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Last Updated: November 25, 2020

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ADDYI Drug Profile

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Which patents cover Addyi, and when can generic versions of Addyi launch?

Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has eighty-two patent family members in thirty-one countries.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.

US ANDA Litigation and Generic Entry Outlook for Addyi

Addyi was eligible for patent challenges on August 18, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 1, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ADDYI
Drug Prices for ADDYI

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Generic Entry Opportunity Date for ADDYI
Generic Entry Date for ADDYI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 ADDYI
Mechanism of ActionP-Glycoprotein Inhibitors

US Patents and Regulatory Information for ADDYI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 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:

Mallinckrodt
Baxter
Moodys
Johnson and Johnson
McKesson
Medtronic

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.