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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 022526


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NDA 022526 describes ADDYI, which is a drug marketed by Sprout Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ADDYI profile page.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.
Summary for 022526
Tradename:ADDYI
Applicant:Sprout Pharms
Ingredient:flibanserin
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022526
Generic Entry Date for 022526*:
Constraining patent/regulatory exclusivity:
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 NDA: 022526
Mechanism of ActionP-Glycoprotein Inhibitors
Suppliers and Packaging for NDA: 022526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADDYI flibanserin TABLET;ORAL 022526 NDA Sprout Pharmaceuticals, Inc. 58604-214 58604-214-30 1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 18, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 9, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

Expired US Patents for NDA 022526

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 ⤷  Sign Up ⤷  Sign Up
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 ⤷  Sign Up ⤷  Sign Up
Sprout Pharms ADDYI flibanserin TABLET;ORAL 022526-001 Aug 18, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.