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Last Updated: March 28, 2024

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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 eighty 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.

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:80
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)*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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.

Pharmacology for vyleesi (autoinjector)
Anatomical Therapeutic Chemical (ATC) Classes for vyleesi (autoinjector)

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

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)

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)

FDA Regulatory Exclusivity protecting vyleesi (autoinjector)

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  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
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
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 Y Y ⤷  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

International Patents for vyleesi (autoinjector)

See the table below for patents covering vyleesi (autoinjector) around the world.

Country Patent Number Title Estimated Expiration
New Zealand 516030 Compositions and methods for treatment of sexual dysfunction using MSH analogs containing the sequence His-Phe-Arg-Trp ⤷  Try a Trial
Israel 180490 ⤷  Try a Trial
Mexico 362610 USOS DE BREMELANOTIDA EN TERAPIA PARA LA DISFUNCIÓN SEXUAL FEMENINA. (BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION.) ⤷  Try a Trial
Mexico PA06013814 TERAPIA DE AGENTES MULTIPLES PARA LA DISFUNCION SEXUAL. (MULTIPLE AGENT THERAPY FOR SEXUAL DYSFUNCTION.) ⤷  Try a Trial
Hong Kong 1047881 ⤷  Try a Trial
Canada 2568218 ⤷  Try a Trial
New Zealand 707246 Uses of bremelanotide in therapy for female sexual dysfunction ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.