Is there a generic for Imipramine pamoate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Imipramine pamoate, referencing the brand TOFRANIL-PM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Imipramine pamoate?

TOFRANIL-PM (NDA 017090, 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 Imipramine pamoate are approved?

Imipramine pamoate is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Imipramine pamoate

Imipramine pamoate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOFRANIL-PM · NDA 017090

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
TOFRANIL-PMRLD×4	SPECGX LLC	NDA 017090	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
IMIPRAMINE PAMOATE×4	RISING	ANDA 202338	—	Jun 28, 2013
IMIPRAMINE PAMOATE×4	HIKMA	ANDA 091099	AB	Apr 16, 2010
IMIPRAMINE PAMOATE×4	LUPIN LTD	ANDA 090444	AB	Apr 16, 2010

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.

Imipramine pamoate — frequently asked questions

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

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