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
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 |
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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.
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 | ||||
>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)
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.
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 |