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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 30th, 1997.

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Drug patent expirations by year for PHENTERMINE HYDROCHLORIDE
Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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SponsorPhase
University of MinnesotaPhase 3
University of FloridaPhase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 3

See all PHENTERMINE HYDROCHLORIDE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE
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

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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