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Last Updated: June 5, 2020

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VYLEESI (AUTOINJECTOR) Drug Profile


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

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

This drug has seventy-seven patent family members in twenty-four 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.

US ANDA Litigation and Generic Entry Outlook for Vyleesi (autoinjector)

Vyleesi (autoinjector) will be eligible for patent challenges on June 21, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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)
Drug patent expirations by year for VYLEESI (AUTOINJECTOR)
Generic Entry Opportunity 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.

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

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

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Dow
Moodys
Baxter
McKinsey

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.