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Last Updated: August 7, 2020

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Phentermine hydrochloride - Generic Drug Details

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

Phentermine hydrochloride is the generic ingredient in eleven branded drugs marketed by Teva, Glaxosmithkline, Ferndale Labs, Shire Richwood, Mast Mm, 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, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Citius Pharms, Avanthi Inc, Actavis Elizabeth, Kvk Tech Inc, Novast Labs, Polygen Pharms, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, and Vivus, and is included in one hundred NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride has two patent family members in two countries.

There are seventeen drug master file entries for phentermine hydrochloride. Thirty-three suppliers are listed for this compound.

Recent Clinical Trials for phentermine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MinnesotaPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Jaime Moore, MD MPHPhase 2

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
Sun Pharm Industries PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040525-001 Oct 23, 2003 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
Camall PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 087226-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mast Mm ONA-MAST phentermine hydrochloride TABLET;ORAL 086260-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Elite Labs Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040228-001 Jun 19, 1997 AA RX No No   Start Trial   Start Trial   Start Trial
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-003 Mar 27, 2012 DISCN No No   Start Trial   Start Trial Y   Start Trial
Elite Labs Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040460-001 Jan 14, 2003 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

Expired US Patents for phentermine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-001 Jun 13, 2011   Start Trial   Start Trial
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-003 Mar 27, 2012   Start Trial   Start Trial
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-002 Jun 13, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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