Details for New Drug Application (NDA): 022437

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NDA 022437 describes TRELSTAR, which is a drug marketed by Verity and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TRELSTAR profile page.

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.

Summary for 022437

Tradename:	TRELSTAR
Applicant:	Verity
Ingredient:	triptorelin pamoate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022437

Generic Entry Date for 022437^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,166,181 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.

Medical Subject Heading (MeSH) Categories for 022437

Antineoplastic Agents, Hormonal
Luteolytic Agents

Suppliers and Packaging for NDA: 022437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437	NDA	Verity Pharmaceuticals Inc.	74676-5906	74676-5906-1	1 KIT in 1 CARTON (74676-5906-1) * 2 mL in 1 VIAL, SINGLE-DOSE (74676-5906-0) * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	EQ 22.5MG BASE/VIAL
Approval Date:	Mar 10, 2010	TE:		RLD:	Yes
Patent:	10,166,181	Patent Expiration:	Jun 30, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022437

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010	5,776,885	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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