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VYLEESI (AUTOINJECTOR) Drug Patent Profile

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When do Vyleesi (autoinjector) patents expire, and what generic alternatives are available?

Vyleesi (autoinjector) is a drug marketed by Cosette and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-one patent family members in twenty-six countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Vyleesi (autoinjector)

Vyleesi (autoinjector) was eligible for patent challenges on June 21, 2023.

Indicators of Generic Entry

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Summary for VYLEESI (AUTOINJECTOR)

International Patents:	81
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	VYLEESI (AUTOINJECTOR) at DailyMed

Drug patent expirations by year for VYLEESI (AUTOINJECTOR)

Pharmacology for VYLEESI (AUTOINJECTOR)

Drug Class	Melanocortin Receptor Agonist
Mechanism of Action	Melanocortin Receptor Agonists

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

VYLEESI (AUTOINJECTOR) is protected by five US patents and one FDA Regulatory Exclusivity.

Patents protecting VYLEESI (AUTOINJECTOR)

Uses of bremelanotide in therapy for female sexual dysfunction
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

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Patent Expiration: ⤷ Sign Up
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

Compositions and methods for treatment of sexual dysfunction
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting VYLEESI (AUTOINJECTOR)

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for VYLEESI (AUTOINJECTOR)

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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

International Patents for VYLEESI (AUTOINJECTOR)

See the table below for patents covering VYLEESI (AUTOINJECTOR) around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1047881		⤷ Sign Up
European Patent Office	1755638		⤷ Sign Up
South Korea	102253526		⤷ Sign Up
Israel	238276	תכשיר המכיל ברמלנוטיד לשימוש בטיפול באי תפקוד מיני נשי (A composituon comprising bremelanotide for use in treating female sexual dysfunction)	⤷ Sign Up
Germany	60019598		⤷ Sign Up
Brazil	112015009936	método para tratar disfunção sexual feminina em uma paciente do sexo feminino diagnosticada com disfunção sexual feminina, mas desejando ter atividade sexual; uso de uma dose de formulação; bremelanotide para uso em um método para tratar disfunção sexual feminina; e unidade de dose pré-carregada	⤷ Sign Up
European Patent Office	1441750		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration