VYLEESI (AUTOINJECTOR) Drug Patent Profile

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Which patents cover Vyleesi (autoinjector), and what generic alternatives are available?

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

This drug has seventy-nine patent family members in twenty-five 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 21, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VYLEESI (AUTOINJECTOR)

International Patents:	79
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)

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

Generic Entry Date for VYLEESI (AUTOINJECTOR)^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 210557 Dosage: SOLUTION;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.

Anatomical Therapeutic Chemical (ATC) Classes for VYLEESI (AUTOINJECTOR)

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYLEESI (AUTOINJECTOR) is ⤷ Try a Trial.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYLEESI (AUTOINJECTOR)

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

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting VYLEESI (AUTOINJECTOR)

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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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
Palatin Technologies	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Palatin Technologies	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Palatin Technologies	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Palatin Technologies	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Palatin Technologies	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019	⤷ Try a Trial	⤷ Try a Trial
>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
Mexico	2007000312	PEPTIDOS CICLICOS PARA EL TRATAMIENTO DE CAQUEXIA. (CYCLIC PEPTIDES FOR TREATMENT OF CACHEXIA.)	⤷ Try a Trial
Brazil	PI0510862		⤷ Try a Trial
Australia	2002322466		⤷ Try a Trial
Georgia, Republic of	P20196947	BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration