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Last Updated: January 29, 2022

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PHENTERMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for phentermine hydrochloride and what is the scope of freedom to operate?

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, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, and Vivus, and is included in one hundred NDAs. There are seven 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 suppliers are listed for this compound.

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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

SponsorPhase
KVK-Tech, Inc.Phase 4
HealthPartners InstitutePhase 4
The University of Texas Health Science Center, HoustonPhase 4

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 Inds Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040790-001 Aug 21, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Kvk Tech PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040876-001 Mar 31, 2008 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Invagen Pharms PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 202942-001 Feb 5, 2014 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 087190-001 Approved Prior to Jan 1, 1982 AA RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Prinston Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040377-001 Jan 4, 2002 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Elite Labs Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040227-001 Jun 18, 1997 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-002 Jun 13, 2011 ⤷  Try it Free ⤷  Try it Free
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-003 Mar 27, 2012 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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