Is there a generic for Doxepin hydrochloride?

Yes. The FDA Orange Book lists 78 approved generic (ANDA) applications for Doxepin hydrochloride, referencing the brand SILENOR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Doxepin hydrochloride?

SILENOR (NDA 022036, CURRAX) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Doxepin hydrochloride?

The Orange Book lists 16 patents against Doxepin 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.

What dosage forms of Doxepin hydrochloride are approved?

Doxepin hydrochloride is approved in the following dosage forms: capsule, concentrate, cream, tablet.

FDA Orange Book · active-ingredient family

Doxepin hydrochloride

Doxepin hydrochloride: 5 brands, 78 generics; first approved May 13, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 78 ANDA applications approved.

Earliest patent expiry May 18, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 18, 2027

in 9 mo

Brand (NDA) products

Originator applications

SILENORRLD
CURRAXNDA 02203620102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB
ZONALONRLDRS
MYLANNDA 0201261994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	CREAM	TOPICAL	Rx	AB

SINEQUANRLD

PFIZERNDA 016798—6 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 10MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 150MG BASE	CAPSULE	ORAL	Discontinued	—

SINEQUANRLD
PFIZERNDA 017516—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML CONCENTRATE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	CONCENTRATE	ORAL	Discontinued	—

DOXEPIN HYDROCHLORIDE

NEW RIVERNDA 016987—6 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 25MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 150MG BASE	CAPSULE	ORAL	Discontinued	—

Generic (ANDA) products (78)

Abbreviated applications

DOXEPIN HYDROCHLORIDE
SUN PHARMA CANADAANDA 2139192026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB
DOXEPIN HYDROCHLORIDE
TAROANDA 21905820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB
DOXEPIN HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 21604120242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB
DOXEPIN HYDROCHLORIDE
AJANTA PHARMA LTDANDA 21856420242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

UNIQUEANDA 21797520235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
AMNEALANDA 2123572023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB
DOXEPIN HYDROCHLORIDE
ZYDUS LIFESCIENCESANDA 20276120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

MICRO LABSANDA 21768820235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
MSNANDA 21482320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx BX
EQ 6MG BASE TABLET ORAL Rx BX

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	BX
EQ 6MG BASE	TABLET	ORAL	Rx	BX

DOXEPIN HYDROCHLORIDE

ZYDUS LIFESCIENCESANDA 21070020235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	BX
EQ 25MG BASE	CAPSULE	ORAL	Rx	BX
EQ 50MG BASE	CAPSULE	ORAL	Rx	BX
EQ 75MG BASE	CAPSULE	ORAL	Rx	BX
EQ 100MG BASE	CAPSULE	ORAL	Rx	BX

DOXEPIN HYDROCHLORIDE
ZYDUS LIFESCIENCESANDA 2101402023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Rx BX
DOXEPIN HYDROCHLORIDE
TEVA PHARMSANDA 2154082023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	CAPSULE	ORAL	Rx	BX

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	CREAM	TOPICAL	Rx	AB

DOXEPIN HYDROCHLORIDE

MSNANDA 21511320225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
ADAPTISANDA 2137962022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Discontinued —

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

DOXEPIN HYDROCHLORIDE

JUBILANT CADISTAANDA 21548320225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

MANKIND PHARMAANDA 21571020225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

ALEMBICANDA 21507620215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

APPCOANDA 21490820215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

IXORA LIFESCIENCEANDA 21161920215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
VELZEN PHARMA PVTANDA 2116182021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Rx AB

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

DOXEPIN HYDROCHLORIDE

EPIC PHARMA LLCANDA 21067520205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

CHARTWELL RXANDA 21026820205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

AIPING PHARM INCANDA 21347420205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

LANNETT CO INCANDA 21299720205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 25MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

DOXEPIN HYDROCHLORIDE
STRIDES PHARMA INTLANDA 20251020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

TAROANDA 21306320205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 25MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—

DOXEPIN HYDROCHLORIDE

AJANTA PHARMA LTDANDA 21262420195 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 21160320195 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE

AMNEAL PHARMS COANDA 20748220175 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
RK PHARMAANDA 20233720162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB
DOXEPIN HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 20195120132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE TABLET ORAL Rx AB
EQ 6MG BASE TABLET ORAL Rx AB
DOXEPIN HYDROCHLORIDE
PHARM ASSOCANDA 0759242004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML CONCENTRATE ORAL Discontinued —
DOXEPIN HYDROCHLORIDERS
LANNETT CO INCANDA 0747211998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML CONCENTRATE ORAL Rx —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0729851991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0729861991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABS TEVAANDA 0729871991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0730541990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0721091990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0730551990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0723751989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0723761989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0723861988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0721101988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PUREPAC PHARMANDA 0723871988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
PHARMOBEDIENT CNSLTGANDA 0719181988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML CONCENTRATE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0715021988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0716531988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0716541988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0715211988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0717631988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0717641988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716851988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716861988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716731988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716741988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716751988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INCANDA 0716761988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE	TABLET	ORAL	Rx	AB
EQ 6MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	CONCENTRATE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	CONCENTRATE	ORAL	Rx	—

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

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

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

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 150MG BASE	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	CONCENTRATE	ORAL	Discontinued	—

DOXEPIN HYDROCHLORIDE

PH HEALTHANDA 07142219876 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 10MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 25MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 50MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 75MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

DOXEPIN HYDROCHLORIDE
TEVA PHARMSANDA 0716091987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML CONCENTRATE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0709721987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0709731987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0709311987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICSANDA 0709321987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0714851987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0714861987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0712381987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0713261987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0712391987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0709521987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SANDOZANDA 0714871987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SANDOZANDA 0715621987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SANDOZANDA 0708271986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SANDOZANDA 0708281986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
SANDOZANDA 0708251986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 75MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0709531986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0709541986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Discontinued —
DOXEPIN HYDROCHLORIDE
WATSON LABSANDA 0709551986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Discontinued —

DOXEPIN HYDROCHLORIDE

MYLAN PHARMS INCANDA 07079119865 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 10MG BASE	CAPSULE	ORAL	Rx	AB
EQ 25MG BASE	CAPSULE	ORAL	Rx	AB
EQ 75MG BASE	CAPSULE	ORAL	Rx	AB
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB

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
9861607	May 18, 2027	in 9 mo	U-620
12083090	May 18, 2027	in 9 mo	U-620
9486437	May 18, 2027	in 9 mo	U-620
10238620	May 18, 2027	in 9 mo	U-620
10653662	May 18, 2027	in 9 mo	U-620
9572814	Jul 20, 2027	in 11 mo	U-620
10653660	Jul 20, 2027	in 11 mo	U-620
11110074	Jul 20, 2027	in 11 mo	U-620
7915307	Aug 24, 2027	in 1 yr	U-620
11234954	Jan 18, 2028	in 1 yr 5 mo	U-620
10548871	Apr 11, 2028	in 1 yr 8 mo	U-620
11096920	Apr 11, 2028	in 1 yr 8 mo	U-620
9907780	Apr 11, 2028	in 1 yr 8 mo	Product
9107898	May 01, 2028	in 1 yr 9 mo	U-620
9532971	Jun 01, 2029	in 2 yr 10 mo	Product
8513299	Sep 07, 2030	in 4 yr 1 mo	U-620

Approval history

FDA approval span

First approval

May 13, 1986

40 yr 10 mo ago

Most recent approval

Apr 28, 2026

4 mo ago

Approvals span 1986–2026 across 83 FDA applications.

Brand (NDA) 56%

Generic (ANDA) 7894%

Doxepin 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.

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