Details for New Drug Application (NDA): 022526
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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 Action | P-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: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 18, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2028 | Product 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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