SUPRENZA Drug Patent Profile

When do Suprenza patents expire, and what generic alternatives are available?

Suprenza is a drug marketed by Citius Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in SUPRENZA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suprenza

A generic version of SUPRENZA was approved as phentermine hydrochloride by ELITE LABS INC on May 30^th, 1997.

Summary for SUPRENZA

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	44
Patent Applications:	909
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SUPRENZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPRENZA
DailyMed Link:	SUPRENZA at DailyMed

See drug prices for SUPRENZA

Anatomical Therapeutic Chemical (ATC) Classes for SUPRENZA

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 SUPRENZA

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 SUPRENZA

SUPRENZA is protected by one US patents.

Patents protecting SUPRENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011		DISCN	No	No			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011		DISCN	No	No			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012		DISCN	No	No			Y

Expired US Patents for SUPRENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011

International Patents for SUPRENZA

See the table below for patents covering SUPRENZA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2001510785
Japan	4947833
World Intellectual Property Organization (WIPO)	2009098169
Portugal	1001748
European Patent Office	1001748	PROCEDE DE PREPARATION DE GRANULES SERVANT A PRODUIRE DES COMPRIMES SOLUBLES DANS LA BOUCHE A DESINTEGRATION RAPIDE (A PROCESS FOR THE PREPARATION OF A GRANULATE SUITABLE TO THE PREPARATION OF RAPIDLY DISINTEGRABLE MOUTH-SOLUBLE TABLETS)

Supplementary Protection Certificates for SUPRENZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212