Is there a generic for Clomipramine hydrochloride?

Yes. The FDA Orange Book lists 21 approved generic (ANDA) applications for Clomipramine hydrochloride, referencing the brand ANAFRANIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clomipramine hydrochloride?

ANAFRANIL (NDA 019906, SPECGX LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Clomipramine hydrochloride are approved?

Clomipramine hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Clomipramine hydrochloride

Clomipramine hydrochloride: 1 brand, 21 generics; first approved Dec 29, 1989; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 21 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

ANAFRANILRLDRS

SPECGX LLCNDA 01990619893 strengths

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

Abbreviated applications

Generic (ANDA) products (21)

CLOMIPRAMINE HYDROCHLORIDE

AUROBINDO PHARMAANDA 21644020233 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

ALEMBICANDA 21182220213 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

AJANTA PHARMA LTDANDA 21389720203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

UNIQUEANDA 21228520203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

MICRO LABSANDA 21321920203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

RK PHARMAANDA 21322120203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

TP ANDA HOLDINGSANDA 21065320203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

IXORA LIFESCIENCEANDA 21136420203 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

JUBILANT CADISTAANDA 21221820193 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

MANKIND PHARMAANDA 21176720193 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

LUPINANDA 20929420183 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

AMNEAL PHARMS COANDA 20863220183 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

ZYDUS PHARMSANDA 20896120173 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

WATSON LABSANDA 07475119983 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

PHARMOBEDIENTANDA 07494719983 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

TEVAANDA 07495819973 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

SANDOZANDA 07495319973 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

TEVAANDA 07484919973 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

TAROANDA 07469419963 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

WATSON LABSANDA 07460019963 strengths

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

CLOMIPRAMINE HYDROCHLORIDE

CHARTWELL RXANDA 07436419963 strengths

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

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Dec 29, 1989

37 yr 1 mo ago

Most recent approval

Mar 20, 2023

3 yr 4 mo ago

Approvals span 1989–2023 across 22 FDA applications.

Brand (NDA) 15%

Generic (ANDA) 2195%

Clomipramine 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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