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Last Updated: July 15, 2024

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, 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 eight drug master file entries for phentermine hydrochloride. Thirty-five suppliers are listed for this compound.

Recent Clinical Trials for phentermine hydrochloride

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

SponsorPhase
WW International Inc.Phase 4
KVK-Tech, Inc.Phase 4
HealthPartners InstitutePhase 4

See all phentermine hydrochloride clinical trials

Pharmacology for phentermine hydrochloride
Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUPRENZA Orally Disintegrating Tablets phentermine hydrochloride 37.5 mg 202088 1 2013-03-22
SUPRENZA Orally Disintegrating Tablets phentermine hydrochloride 15 mg and 30 mg 202088 1 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
Mast Mm ONA-MAST phentermine hydrochloride CAPSULE;ORAL 086511-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 088610-001 Jun 4, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 084487-001 Apr 9, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-003 Mar 27, 2012 ⤷  Sign Up ⤷  Sign Up
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-002 Jun 13, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for phentermine hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2254558 COMPRIMÉS À DISSOLUTION ORALE AYANT UN ASPECT MOUCHETÉ (ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009098169 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for phentermine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 2190050-1 Sweden ⤷  Sign Up PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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