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Last Updated: February 25, 2021

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PHENTERMINE HYDROCHLORIDE Drug Profile

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Which patents cover Phentermine Hydrochloride, and what generic alternatives are available?

Phentermine Hydrochloride is a drug marketed by Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Teva, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Actavis Elizabeth, Kvk Tech Inc, Novast Labs, Polygen Pharms, Prinston Inc, Sandoz Inc, and Sun Pharm Inds Inc. and is included in eighty-seven NDAs.

The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Phentermine Hydrochloride

A generic version of PHENTERMINE HYDROCHLORIDE was approved as phentermine hydrochloride by ELITE LABS INC on May 30^th, 1997.

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Summary for PHENTERMINE HYDROCHLORIDE

US Patents:	0
Applicants:	31
NDAs:	87
Suppliers / Packagers:	30
Bulk Api Vendors:	36
Clinical Trials:	40
Patent Applications:	805
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENTERMINE HYDROCHLORIDE
DailyMed Link:	PHENTERMINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PHENTERMINE HYDROCHLORIDE

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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Sponsor	Phase
University of Minnesota	Phase 3
University of Florida	Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3

See all PHENTERMINE HYDROCHLORIDE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE

Drug Class	Sympathomimetic Amine Anorectic
Physiological Effect	Appetite Suppression Increased Sympathetic Activity

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
SUPRENZA	TABLET, ORALLY DISINTEGRATING;ORAL	phentermine hydrochloride	202088	2013-03-22
SUPRENZA	TABLET, ORALLY DISINTEGRATING;ORAL	phentermine hydrochloride	202088	2012-10-19

US Patents and Regulatory Information for PHENTERMINE HYDROCHLORIDE

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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
Chartwell Rx	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	083923-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Nuvo Pharm	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	205019-001	Dec 5, 2014	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Ivax Pharms	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	086329-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Prinston Inc	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	040377-001	Jan 4, 2002	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Sandoz	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	088414-001	Oct 19, 1983		DISCN	No	No	Start Trial	Start Trial				Start Trial
Upsher Smith Labs	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	088430-001	Mar 27, 1984		DISCN	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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