Details for New Drug Application (NDA): 022058

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NDA 022058 describes SUPPRELIN LA, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SUPPRELIN LA profile page.

The generic ingredient in SUPPRELIN LA is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.

Summary for 022058

Tradename:	SUPPRELIN LA
Applicant:	Endo Operations
Ingredient:	histrelin acetate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022058

Generic Entry Date for 022058^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,062,652 Dosage: IMPLANT;SUBCUTANEOUS

^*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.

Pharmacology for NDA: 022058

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Suppliers and Packaging for NDA: 022058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058	NDA	ENDO USA, Inc.	67979-002	67979-002-01	1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;SUBCUTANEOUS			Strength	50MG
Approval Date:	May 3, 2007	TE:		RLD:	Yes
Patent:	8,062,652	Patent Expiration:	Jun 16, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY

Expired US Patents for NDA 022058

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	5,266,325	⤷ Subscribe
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	5,292,515	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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