Imipramine hydrochloride - Generic Drug Details

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What are the generic drug sources for imipramine hydrochloride and what is the scope of patent protection?

Imipramine hydrochloride is the generic ingredient in five branded drugs marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, West Ward, Abbott, Alra, and Sanofi Aventis Us, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for imipramine hydrochloride. Fourteen suppliers are listed for this compound.

Sponsor

Phase

Wright State University

Phase 1

Benha University

N/A

Wright State Physicians

Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	086268-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Specgx Llc	TOFRANIL	imipramine hydrochloride	TABLET;ORAL	087846-001	May 22, 1984	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vangard	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	088036-001	Nov 3, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	088276-001	Oct 21, 1983	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	084869-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PRESAMINE	imipramine hydrochloride	TABLET;ORAL	011836-007	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	081048-001	Jun 5, 1990		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	19
NDAs:	40
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	52
Patent Applications:	1,486
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in imipramine hydrochloride?	imipramine hydrochloride excipients list
DailyMed Link:	imipramine hydrochloride at DailyMed