Viewing data from:

SUPRENZA

NDA

PHENTERMINE HYDROCHLORIDE | N202088 | CITIUS PHARMACEUTICALS LLC

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

2027

2028

2029

Today

8440170

Mar. 14, 2029IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00245	8440170	IPR	Spangenberg, Erich et al.	Terminated	2015-11-24	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALPEX PHARMA, S.A. et al v. ZYDUS PHARMACEUTICALS USA, INC. et al 1:2013cv04076 1 patentANDA 204663phentermine hydrochloride	D.N.J.	2013-07-01	Terminated 2013-10-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED USA LLCPHENTERMINE HYDROCHLORIDE USP

DMF 34321979

OLON SPAPHENTERMINE HYDROCHLORIDE

DMF 152892001

CHEMISCHE FABRIK BERG GMBHPHENTERMINE HYDROCHLORIDE USP

DMF 154422001

SYMED LABS LTDPHENTERMINE HYDROCHLORIDE

DMF 248562011

ZYDUS LIFESCIENCES LTDPHENTERMINE HYDROCHLORIDE USP

DMF 261452012

MALLADI DRUGS AND PHARMACEUTICALS LTDPHENTERMINE HYDROCHLORIDE

DMF 386572023

TROPONWERKE GMBH CO KGInactivePHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE)

DMF 12141968

CAMBREX CHARLES CITY INCInactivePHENTERMINE HYDROCHLORIDE

DMF 154612001

CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INCInactivePHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT

DMF 159402002

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2013	SUPPL -6	View Letter (PDF)
Jun 12, 2013	SUPPL -5	View Letter (PDF)
Dec 11, 2012	SUPPL -4	View Letter (PDF)
Mar 30, 2012	SUPPL -2	View Letter (PDF)
Mar 29, 2012	ORIG -1	View Letter (PDF)
Oct 17, 2011	SUPPL -1	View Letter (PDF)
Jun 16, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

1 patent0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 13, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8440170	Mar 14, 2029	—	—	Yes	—	—

#002 — 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

1 patent0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 13, 2011

#003 — 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

1 patent0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Mar 27, 2012