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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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:	⤷ Sign Up	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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.