Is there a generic for Minocycline hydrochloride?

Yes. The FDA Orange Book lists 28 approved generic (ANDA) applications for Minocycline hydrochloride, referencing the brand EMROSI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Minocycline hydrochloride?

EMROSI (NDA 219015, JOURNEY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Minocycline hydrochloride?

The Orange Book lists 29 patents against Minocycline hydrochloride products, with the earliest listed expiry in 2027. 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.

Does Minocycline hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Minocycline hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Minocycline hydrochloride are approved?

Minocycline hydrochloride is approved in the following dosage forms: aerosol, foam, capsule, capsule, extended release, injectable, powder, extended release, suspension, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Minocycline hydrochloride

Minocycline hydrochloride: 12 brands, 28 generics; first approved Aug 10, 1982; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 28 ANDA applications approved.

Earliest patent expiry Mar 07, 2027Latest exclusivity ends Nov 01, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 07, 2027

in 5 mo

Brand (NDA) products

Originator applications

EMROSIRLDRS
JOURNEYNDA 2190152024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx -
ZILXIRLDRS
JOURNEYNDA 2136902020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1.5% BASE AEROSOL, FOAM TOPICAL Rx -
AMZEEQRLDRS
JOURNEYNDA 2123792019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 4% BASE AEROSOL, FOAM TOPICAL Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.5% BASE	AEROSOL, FOAM	TOPICAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4% BASE	AEROSOL, FOAM	TOPICAL	Rx	-

SOLODYNRLD

BAUSCHNDA 05080820068 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

ARESTINRLDRS
ORAPHARMANDA 0507812001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE POWDER, EXTENDED RELEASE DENTAL Rx -
MINOCINRLD
BAUSCHNDA 05064919903 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
EQ 75MG BASE CAPSULE ORAL Discontinued -
MINOCYCLINE HYDROCHLORIDERLD
TRIAX PHARMSNDA 05045119822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Discontinued -
EQ 50MG BASE TABLET ORAL Discontinued -
MINOCINRLDRS
REMPEXNDA 050444-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx -
MINOLIRA
EPI HLTHNDA 20926920172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued -
EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	POWDER, EXTENDED RELEASE	DENTAL	Rx	-

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
EQ 75MG 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	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

XIMINO

JOURNEYNDA 20192220125 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCIN
TRIAX PHARMSNDA 050315-2 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 -
MINOCIN
BAUSCHNDA 050445-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/5ML SUSPENSION ORAL Discontinued -

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/5ML	SUSPENSION	ORAL	Discontinued	-

Generic (ANDA) products (28)

Abbreviated applications

MINOCYCLINE HYDROCHLORIDE
REGCON HOLDINGSANDA 21546620223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 21366220203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB

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

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

MINOCYCLINE HYDROCHLORIDE

RISINGANDA 20344320193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE
RISINGANDA 20146720192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued -
EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

ZYDUS PHARMSANDA 20355320178 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

ALKEM LABS LTDANDA 20445320168 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 09021720163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Discontinued -
EQ 75MG BASE TABLET ORAL Discontinued -
EQ 100MG BASE TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Discontinued	-
EQ 75MG BASE	TABLET	ORAL	Discontinued	-
EQ 100MG BASE	TABLET	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

SUN PHARMANDA 20439420157 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

SUN PHARM INDS LTDANDA 09111820147 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDS INCANDA 09086720133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued -
EQ 75MG BASE CAPSULE ORAL Discontinued -
EQ 100MG BASE CAPSULE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	-
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	-
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 20226120128 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

MINOCYCLINE HYDROCHLORIDE

LUPINANDA 09142420114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 55MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

MINOCYCLINE HYDROCHLORIDE

PHARMOBEDIENTANDA 09091120103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

SANDOZANDA 09042220093 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

MINOCYCLINE HYDROCHLORIDE

BARR LABS INCANDA 06548520097 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 65MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 115MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 105MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE

IMPAX LABS INCANDA 09002420093 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 45MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 90MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
EQ 135MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

MINOCYCLINE HYDROCHLORIDE
AUROBINDO PHARMAANDA 06547020083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 75MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
CHARTWELL RXANDA 06543620073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
TORRENTANDA 06515620043 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
ZYDUSANDA 06300920032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 75MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
STRIDES PHARMA INTLANDA 06513120033 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
TORRENTANDA 06506220003 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 75MG BASE CAPSULE ORAL Rx AB
EQ 100MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
WATSON LABSANDA 06306519992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 75MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
IMPAX LABSANDA 06500519993 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
EQ 75MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
ZYDUSANDA 0630111992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
MINOCYCLINE HYDROCHLORIDE
WATSON LABS TEVAANDA 0631811991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
DYNACIN
ALVOGENANDA 06306719903 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued -
EQ 75MG BASE CAPSULE ORAL Discontinued -
EQ 50MG BASE CAPSULE ORAL Discontinued -
MINOCIN
LEDERLEANDA 062139-
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 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG 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 50MG BASE	TABLET	ORAL	Rx	AB
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Rx	AB
EQ 75MG BASE	TABLET	ORAL	Rx	AB
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
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG 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	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB

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
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	-
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	-
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	-

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

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Nov 01, 2027
in 1 yr

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
7919483	Mar 07, 2027	in 5 mo	U-124
7541347	Apr 02, 2027	in 5 mo	U-917
7544373	Apr 02, 2027	in 5 mo	Product
10137200	Oct 01, 2030	in 4 yr	U-2647
8865139	Oct 01, 2030	in 4 yr	ProductU-2647
9675700	Oct 01, 2030	in 4 yr	ProductU-2647
8992896	Oct 01, 2030	in 4 yr	ProductU-2647
10086080	Oct 01, 2030	in 4 yr	U-2647
10213512	Oct 01, 2030	in 4 yr	ProductU-2647
10517882	Oct 01, 2030	in 4 yr	U-2647
10821187	Oct 01, 2030	in 4 yr	U-2647
8945516	Oct 01, 2030	in 4 yr	Product
10265404	Oct 01, 2030	in 4 yr	Product
10322186	Oct 01, 2030	in 4 yr	U-1631
10946101	Oct 01, 2030	in 4 yr	U-1631
12138311	Oct 01, 2030	in 4 yr	U-1631
12661407	Oct 01, 2030	in 4 yr	U-1631
9084802	May 12, 2031	in 4 yr 7 mo	U-282
9278105	May 12, 2031	in 4 yr 7 mo	U-282
12161656	May 12, 2031	in 4 yr 7 mo	Product
9192615	Nov 17, 2031	in 5 yr 2 mo	Product
11944634	Oct 16, 2032	in 6 yr 1 mo	Product
11103517	Apr 07, 2036	in 9 yr 7 mo	Product
10398641	Sep 08, 2037	in 11 yr	U-2647
10849847	Sep 08, 2037	in 11 yr	U-2647
11364212	Jan 07, 2039	in 12 yr 5 mo	U-4043
11191740	Jan 07, 2039	in 12 yr 5 mo	U-4043
10905664	Jan 07, 2039	in 12 yr 5 mo	U-4043
12594252	Jan 07, 2039	in 12 yr 5 mo	U-4043

Approval history

FDA approval span

First approval

Aug 10, 1982

44 yr 10 mo ago

Most recent approval

Nov 01, 2024

2 yr ago

Approvals span 1982–2024 across 40 FDA applications.

Brand (NDA) 1230%

Generic (ANDA) 2870%

Minocycline hydrochloride: 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.

Ask AI about Minocycline hydrochloride

Key facts

Active ingredient: Minocycline hydrochloride
Brand (NDA): 12
Generic (ANDA): 28
Reference-listed drug: EMROSI
Dosage forms: AEROSOL, FOAM, CAPSULE, CAPSULE, EXTENDED RELEASE, INJECTABLE, POWDER, EXTENDED RELEASE, SUSPENSION, TABLET, TABLET, EXTENDED RELEASE
Routes: DENTAL, INJECTION, ORAL, TOPICAL
TE codes: AB
Earliest patent expiry: Mar 07, 2027
Latest exclusivity: Nov 01, 2027