Is there a generic for Doxycycline hyclate?

Yes. The FDA Orange Book lists 99 approved generic (ANDA) applications for Doxycycline hyclate, referencing the brand LYMEPAK. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Doxycycline hyclate?

LYMEPAK (NDA 209844, CHARTWELL PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Doxycycline hyclate?

The Orange Book lists 4 patents against Doxycycline hyclate products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Doxycycline hyclate are approved?

Doxycycline hyclate is approved in the following dosage forms: capsule, capsule, coated pellets, capsule, delayed release, injectable, system, extended release, tablet, tablet, delayed release.

FDA Orange Book · active-ingredient family

Doxycycline hyclate

Doxycycline hyclate: 11 brands, 99 generics; first approved Mar 29, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 99 ANDA applications approved.

Earliest patent expiry Feb 03, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 03, 2028

in 1 yr 6 mo

Brand (NDA) products

Originator applications

LYMEPAKRLD
CHARTWELL PHARMANDA 2098442018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
ACTICLATE CAPRLD
CHARTWELL RXNDA 2082532016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—

DORYXRLD

MAYNE PHARMANDA 05079520148 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 50MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 60MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	—
EQ 120MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

ACTICLATERLD
CHARTWELL RXNDA 20593120142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DORYXRLD
MAYNE PHARMANDA 05058220012 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued —
EQ 75MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued —
PERIOSTATRLD
GALDERMA LABS LPNDA 0507832001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Discontinued —
PERIOSTATRLD
COLLAGENEXNDA 0507441998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE CAPSULE ORAL Discontinued —
ATRIDOXRLD
DEN-MATNDA 0507511998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG SYSTEM, EXTENDED RELEASE PERIODONTAL Discontinued —
VIBRAMYCINRLD
PFIZERNDA 050007—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
VIBRAMYCINRLD
PFIZERNDA 050442—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued —
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
VIBRA-TABSRLD
PFIZERNDA 050533—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	SYSTEM, EXTENDED RELEASE	PERIODONTAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (99)

Abbreviated applications

DOXYCYCLINE HYCLATE
AVET LIFESCIENCESANDA 2032762026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
DOXYCYCLINE HYCLATE
MACLEODS PHARMS LTDANDA 2111372025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
STRIDES PHARMA INTLANDA 06253820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
EQ 50MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
MACLEODS PHARMS LTDANDA 2114182025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
STERISCIENCEANDA 2179722025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
ASPIROANDA 2188882025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
DR REDDYSANDA 2187532025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
PHARMOBEDIENTANDA 2170782025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
AMNEALANDA 2174872024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
DOXYCYCLINE HYCLATE
KINDOSANDA 2180532024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
HERITAGEANDA 2178542024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
SLATE RUN PHARMAANDA 21768520242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
PHARMOBEDIENTANDA 2095602024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
TORRENTANDA 21435620242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Discontinued —
EQ 150MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
LUPINANDA 2177942024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 50MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 200MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

DOXYCYCLINE HYCLATE

LUPINANDA 20874120238 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 60MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 120MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE
GLANDANDA 2155832023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
PH HEALTHANDA 2166902022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
AMNEALANDA 2165992022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
PRAXGENANDA 2124872022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE

ALEMBICANDA 21307520224 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB

DOXYCYCLINE HYCLATE
NESHER PHARMSANDA 20826320212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
ALEMBICANDA 21053620212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
EQ 50MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
CHARTWELLANDA 06250520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
EQ 50MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
ORYZAANDA 2134752021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
EPIC PHARMA LLCANDA 21420720202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
BIONPHARMAANDA 20939320202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
RISINGANDA 20998720202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Discontinued —
EQ 150MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
ALEMBICANDA 21174420202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
AJANTA PHARMA LTDANDA 21158420202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
ZHEJIANG YONGTAIANDA 21261020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
ACELLAANDA 2106642020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
ALEMBICANDA 2105372020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
CHANGZHOU PHARMANDA 2113432019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
CHANGZHOU PHARMANDA 2094022019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
APOTEXANDA 20924320192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Discontinued —
EQ 150MG BASE TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 50MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 50MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE

PRINSTON INCANDA 20749420193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 50MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB

DOXYCYCLINE HYCLATE

ZYDUS PHARMSANDA 20677220183 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE
AVET LIFESCIENCESANDA 2099692018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
AJANTA PHARMA LTDANDA 21101220182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
ALEMBICANDA 21052720182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
ZYDUS LIFESCIENCESANDA 20777420182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE

ACTAVIS ELIZABETHANDA 09013420184 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 50MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB

DOXYCYCLINE HYCLATE
ZYDUS LIFESCIENCESANDA 2077732017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
AMNEAL PHARMS COANDA 20937220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Discontinued —
EQ 150MG BASE TABLET ORAL Discontinued —
DOXYCYCLINERS
ZYDUS PHARMSANDA 20775720172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
LUPINANDA 20881820172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
NOVEL LABS INCANDA 2075582017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
DR REDDYS LABS SAANDA 20876520172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET ORAL Rx AB
EQ 150MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
AMNEAL PHARMSANDA 2072892016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB

DOXYCYCLINE HYCLATE

RISINGANDA 09043120165 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 50MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 80MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

DOXYCYCLINE HYCLATE

HERITAGEANDA 20085620134 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 75MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 100MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 150MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB
EQ 200MG BASE	TABLET, DELAYED RELEASE	ORAL	Rx	AB

DOXYCYCLINE
MYLAN LABS LTDANDA 0914062012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
AUROBINDO PHARMA USAANDA 0910522012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —
DOXYCYCLINE HYCLATE
IMPAX LABS INCANDA 09050520102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —
EQ 100MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —
DOXYCYCLINE HYCLATE
PHARMOBEDIENTANDA 0652872006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
BAUSCHANDA 06528120052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued —
EQ 100MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued —
DOXYCYCLINE HYCLATERS
CHARTWELL MOLECULARANDA 0652772005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
HIKMA INTL PHARMSANDA 0651032005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
EPIC PHARMA LLCANDA 0651822005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
HERITAGE PHARMAANDA 0651632005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
SUN PHARM INDUSTRIESANDA 0651342005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
HIKMA INTL PHARMSANDA 0650952003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
PLIVAANDA 0631871992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE, COATED PELLETS ORAL Discontinued —
DOXYCYCLINE HYCLATE
WEST-WARD PHARMS INTANDA 06299219892 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
INTERPHARMANDA 06276319882 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
INTERPHARMANDA 0627641988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE
HIKMAANDA 06256919882 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued —
DOXYCYCLINE HYCLATE
PVT FORMANDA 06263119862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
SUN PHARM INDUSTRIESANDA 06267619862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 50MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
SUN PHARM INDUSTRIESANDA 0626771986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
WARNER CHILCOTTANDA 06259419852 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DORYX
WARNER CHILCOTTANDA 0626531985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued —
DOXYCYCLINE HYCLATE
WARNER CHILCOTTANDA 0625931985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
HALSEYANDA 06211919852 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXY-LEMMON
TEVAANDA 0625811985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
SUPERPHARMANDA 0624941985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
HIKMA INTL PHARMSANDA 06239619842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 50MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
SUPERPHARMANDA 06246919842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
PAR PHARMANDA 0624341984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
CHARTWELLANDA 06250019842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB
DOXY-LEMMON
TEVAANDA 06249719842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
RANBAXYANDA 06247919832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
PAR PHARMANDA 0624421983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXY 100RS
FRESENIUS KABI USAANDA 06247519832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP
EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP
DOXYCYCLINE HYCLATE
HEATHERANDA 06246319832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE
HIKMAANDA 06245019832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued —
DOXYCYCLINE HYCLATE
EPIC PHARMA LLCANDA 06226919832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
EQ 50MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
HEATHERANDA 0624621983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
WATSON LABSANDA 06239219832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Discontinued —
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
MYLANANDA 0624321983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
ACTAVIS LABS FL INCANDA 0624211983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
DOXYCYCLINE HYCLATE
MUTUAL PHARMANDA 06241819832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
ACTAVIS LABS FL INCANDA 06203119822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 50MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
MUTUAL PHARMANDA 0623911982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued —
DOXYCYCLINE HYCLATE
STRIDES PHARMAANDA 06233719822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB
DOXYCYCLINE HYCLATE
WATSON LABSANDA 061717—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCYCLINE HYCLATE
WATSON LABSANDA 062142—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXYCHEL HYCLATE
RACHELLEANDA 061953—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8715724	Feb 03, 2028	in 1 yr 6 mo	Product
9295652	Oct 23, 2034	in 8 yr 3 mo	ProductU-918
9511031	Oct 23, 2034	in 8 yr 3 mo	Product
9446057	Dec 23, 2034	in 8 yr 5 mo	ProductU-918

Approval history

FDA approval span

First approval

Mar 29, 1982

45 yr 1 mo ago

Most recent approval

Feb 19, 2026

6 mo ago

Approvals span 1982–2026 across 110 FDA applications.

Brand (NDA) 1110%

Generic (ANDA) 9990%

Doxycycline hyclate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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