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Last Updated: March 28, 2024

Phentermine hydrochloride - Generic Drug Details


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What are the generic 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
Merro Pharm Usa PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 206342-001 Nov 18, 2016 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Elite Labs Inc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040460-001 Jan 14, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 203068-001 Aug 6, 2014 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 088625-001 Aug 23, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040555-001 Apr 15, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avanthi Inc LOMAIRA phentermine hydrochloride TABLET;ORAL 203495-001 Sep 12, 2016 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 087190-001 Approved Prior to Jan 1, 1982 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-002 Jun 13, 2011 ⤷  Try a Trial ⤷  Try a Trial
Citius Pharms SUPRENZA phentermine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202088-003 Mar 27, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for phentermine hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2009098169 ⤷  Try a Trial
European Patent Office 2254558 COMPRIMÉS À DISSOLUTION ORALE AYANT UN ASPECT MOUCHETÉ (ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE) ⤷  Try a Trial
>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 ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.