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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.
The generic ingredient in ADDYI is flibanserin. There is one drug master file entry for this compound. 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:
REVISION TO THE INDICATION TO INCLUDE WOMEN LESS THAN 65 YEARS OF AGE INDEPENDENT OF REPRODUCTIVE STATUS 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 | |||||
| Regulatory Exclusivity Expiration: | Dec 13, 2028 | ||||||||
| Regulatory Exclusivity Use: | REVISION TO THE INDICATION TO INCLUDE WOMEN LESS THAN 65 YEARS OF AGE INDEPENDENT OF REPRODUCTIVE STATUS | ||||||||
| Patent: | 7,151,103 | 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 | 7,420,057 | ⤷ Start Trial |
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | 8,227,471 | ⤷ Start Trial |
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | 9,468,639 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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