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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, Novast Labs, Polygen Pharms, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, and Vivus, and is included in one hundred NDAs. There are eleven 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-six suppliers are listed for this compound.

Summary for phentermine hydrochloride

International Patents:	2
US Patents:	11
Tradenames:	11
Applicants:	39
NDAs:	100
Drug Master File Entries:	17
Suppliers / Packagers:	36
Bulk Api Vendors:	36
Clinical Trials:	32
Patent Applications:	1,247
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for phentermine hydrochloride
DailyMed Link:	phentermine hydrochloride at DailyMed

Recent Clinical Trials for phentermine hydrochloride

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

Sponsor	Phase
University of Colorado- Nutrition Obesity Research Center	Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Jaime Moore, MD MPH	Phase 2

See all phentermine hydrochloride clinical trials

Recent Litigation for phentermine hydrochloride

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ALPEX PHARMA, S.A. v. ZYDUS PHARMACEUTICALS USA, INC.	2013-07-01

See all phentermine hydrochloride litigation

PTAB Litigation

Petitioner	Date
Erich, Spangenberg	2015-11-24

See all phentermine hydrochloride litigation

Pharmacology for phentermine hydrochloride

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

Synonyms for phentermine hydrochloride

.alpha.-Methylamphetamine hydrochloride

.alpha.,.alpha.-Dimethylphenethylamine hydrochloride

(1,1-DIMETHYL-2-PHENYL)ETHYLAMINE HYDROCHLORIDE

0K2I505OTV

1-Phenyl-2-methyl-2-aminopropane hydrochloride

1-phenyl-2-methyl-2-aminopropanehydrochloride

1-Phenyl-2-methyl-2-propylamine Hydrochloride

1,1-Dimethyl-2-phenylethylamine hydrochloride

1197-21-3

122-09-8 (Parent)

2-Amino-2-methyl-1-phenylpropane hydrochloride

2-methyl-1-phenyl-2-propanamine hydrochloride

2-Methyl-1-phenylpropan-2-amine hydrochloride

2-methyl-1-phenylpropan-2-amine;hydrochloride

AC1L2F9M

Adipex-P

Adipex-p (TN)

AKOS015891196

alpha-Methylamphetamine hydrochloride

alpha-methylamphetaminehydrochloride

alpha,alpha-dimethyl-phenethylaminhydrochloride

alpha,alpha-Dimethylphenethylamine hydrochloride

ANW-58508

AOB5784

API0007710

AS01627

BCP23776

Benzeneethanamine, alpha,alpha-dimethyl-, hydrochloride

Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride

Benzeneethanamine,.alpha.-dimethyl, hydrochloride

benzeneethanamine,alpha,alpha-dimethyl,hydrochloride

CCG-221139

CHEBI:50506

CHEMBL1200912

CTK6A7128

D05459

DEA No. 1640

DTXSID20152550

Duromine Hydrochloride

EINECS 214-821-9

Fastin

Fastin (TN)

FT-0673716

I01-8880

I14-44888

Inoamin Hydrochloride

Ionamin Hydrochloride

Linyl Hydrochloride

Lipopill Hydrochloride

Lomaira

Lonamin Hydrochloride

LS-103359

MG 18370

MG 18570

Mirapront Hydrochloride

MLS003882563

NCAIGTHBQTXTLR-UHFFFAOYSA-N

Normephentermine Hydrochloride

NSC 44090

NSC-44090

NSC44090

Obestin-30

Oby-Trim

Omnibex Hydrochloride

Ona Mast

Ona-Mast

Ona-Mast hydrochloride

Phenethylamine, alpha,alpha-dimethyl-, hydrochloride

Phenteral

Phenteramine hydrochloride

Phentermine HCl

Phentermine hydrochloride (USP)

Phentermine hydrochloride [USAN]

Phentermine hydrochloride [USP]

Phentermine hydrochloride, >=98% (HPLC)

Phentermine hydrochloride, United States Pharmacopeia (USP) Reference Standard

Phentermyl Wyncaps

Phenyl-t-butylamine hydrochloride

phenyl-t-butylaminehydrochloride

Phenyl-tert-butylamine Hydrochloride

S 58

SCHEMBL41585

SMR000058739

Suprenza

TC-147253

TL8000587

Tora

UNII-0K2I505OTV

Wilpo (VAN)

Wilpo Hydrochloride

wilpohydrochloride

WLN: ZX1&1&1R &GH

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
Chartwell Rx	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	088625-001	Aug 23, 1984		DISCN	No	No
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012		RX	Yes	No
Invagen Pharms	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	202858-002	Feb 14, 2014	AA	RX	No	No
Teva	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	086911-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mast Mm	ONA-MAST	phentermine hydrochloride	CAPSULE;ORAL	086516-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Aurolife Pharma Llc	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	203068-001	Aug 6, 2014	AA	RX	No	No
Chartwell Rx	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	087805-001	Dec 6, 1982		DISCN	No	No

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
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011

International Patents for phentermine hydrochloride

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009098169
European Patent Office	2254558