TRELSTAR Drug Patent Profile

Which patents cover Trelstar, and when can generic versions of Trelstar launch?

Trelstar is a drug marketed by Verity and is included in three NDAs. There is one patent protecting this drug.

This drug has forty-six patent family members in thirty-one countries.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trelstar

Trelstar was eligible for patent challenges on June 15, 2004.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRELSTAR

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	10
Patent Applications:	3,116
Drug Prices:	Drug price information for TRELSTAR
What excipients (inactive ingredients) are in TRELSTAR?	TRELSTAR excipients list
DailyMed Link:	TRELSTAR at DailyMed

See drug prices for TRELSTAR

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TRELSTAR

NDA:

022437

Dosage:

INJECTABLE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRELSTAR

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 2
Sir Mortimer B. Davis - Jewish General Hospital	Phase 2/Phase 3
Medical College of Wisconsin

See all TRELSTAR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRELSTAR

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRELSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes			Y

Expired US Patents for TRELSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000

International Patents for TRELSTAR

When does loss-of-exclusivity occur for TRELSTAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRELSTAR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2164467	COMPOSITION PHARMACEUTIQUE À LIBÉRATION LENTE, FAITE DE MICROPARTICULES (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Slovenia	2164467
Canada	2688478	COMPOSITION PHARMACEUTIQUE A LIBERATION LENTE, FAITE DE MICROPARTICULES (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Canada	2021767	METHODE DE PREPARATION D'UN COMPOSE PHARMACEUTIQUE SOUS FORME DE MICROPARTICULES (METHOD FOR PREPARING A PHARMACEUTICAL COMPOSITION IN THE FORM OF MICROPARTICLES)