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Last Updated: November 21, 2024

PHENTERMINE HYDROCHLORIDE Drug Patent 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, Aurobindo Pharma Ltd, Kvk Tech Inc, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, and Actavis Labs Fl Inc. and is included in eighty-eight NDAs.

The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phentermine Hydrochloride

A generic version of PHENTERMINE HYDROCHLORIDE was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25^th, 2024.

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Summary for PHENTERMINE HYDROCHLORIDE

US Patents:	0
Applicants:	33
NDAs:	88
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	47
Patent Applications:	909
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENTERMINE HYDROCHLORIDE
DailyMed Link:	PHENTERMINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PHENTERMINE HYDROCHLORIDE

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Johns Hopkins University	Phase 4
WW International Inc.	Phase 4

See all PHENTERMINE HYDROCHLORIDE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE

Drug Class	Sympathomimetic Amine Anorectic
Physiological Effect	Appetite Suppression Increased Sympathetic Activity

Anatomical Therapeutic Chemical (ATC) Classes for PHENTERMINE HYDROCHLORIDE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982-004	Jun 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nuvo Pharm	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	205019-001	Dec 5, 2014	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Pharms	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	086329-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	040377-001	Jan 4, 2002	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	088414-001	Oct 19, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	088430-001	Mar 27, 1984		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

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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.