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 twelve 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, Aurobindo Pharma Ltd, Kvk Tech Inc, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, Actavis Labs Fl Inc, and Vivus Llc, and is included in one hundred and one 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-three suppliers are listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE

International Patents:	2
US Patents:	7
Tradenames:	12
Applicants:	41
NDAs:	101
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	47
Patent Applications:	1,403
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENTERMINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PHENTERMINE HYDROCHLORIDE?	PHENTERMINE HYDROCHLORIDE excipients list
DailyMed Link:	PHENTERMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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

Sponsor	Phase
KVK-Tech, Inc.	Phase 4
HealthPartners Institute	Phase 4
The University of Texas Health Science Center, Houston	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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Glossary

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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
Sandoz	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	085671-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	085417-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	204663-001	Jun 28, 2017		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	087918-001	Dec 22, 1983		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

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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

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

Supplementary Protection Certificates for PHENTERMINE HYDROCHLORIDE

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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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