Details for New Drug Application (NDA): 210557

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NDA 210557 describes VYLEESI (AUTOINJECTOR), which is a drug marketed by Cosette and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VYLEESI (AUTOINJECTOR) profile page.

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.

Summary for 210557

Tradename:	VYLEESI (AUTOINJECTOR)
Applicant:	Cosette
Ingredient:	bremelanotide acetate
Patents:	5

Pharmacology for NDA: 210557

Mechanism of Action	Melanocortin Receptor Agonists

Suppliers and Packaging for NDA: 210557

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141	80064-141-02	2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01)
VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141	80064-141-04	4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Approval Date:	Jun 21, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 21, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Nov 5, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
Patent:	⤷ Sign Up	Patent Expiration:	Apr 29, 2041	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING ACQUIRED, GENERALIZED HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN A PREMENOPAUSAL FEMALE PATIENT WITH CONTROLLED HYPERTENSION BY INJECTING BREMELANOTIDE MORE THAN ONCE WITH AT LEAST 24 HOURS BETWEEN DOSES AND NO MORE THAN 8 DOSES PER MONTH

Expired US Patents for NDA 210557

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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