Flibanserin - Generic Drug Details
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What are the generic sources for flibanserin and what is the scope of patent protection?
Flibanserin
is the generic ingredient in one branded drug marketed by Sprout Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Flibanserin has eighty-two patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for flibanserin
International Patents: | 82 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 19 |
Patent Applications: | 502 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in flibanserin? | flibanserin excipients list |
DailyMed Link: | flibanserin at DailyMed |
Recent Clinical Trials for flibanserin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Andrew McDonald | Phase 2 |
Sprout Pharmaceuticals, Inc | Phase 2 |
Mohit Khera | Phase 2 |
Pharmacology for flibanserin
Mechanism of Action | P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for flibanserin
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for flibanserin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20040023704 | See Plans and Pricing | |
South Korea | 20110132479 | See Plans and Pricing | |
Croatia | P20040352 | PRIMJENA FLIBANSERINA U LIJEČENJU SEKSUALNE DISFUNKCIJE (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS) | See Plans and Pricing |
South Africa | 200309586 | STABLE POLYMORPH OF FLIBANSERIN TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS | See Plans and Pricing |
Serbia | 50876 | UPOTREBA FLIBANSERINA U LEČENJU SEKSUALNIH POREMEĆAJA (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS) | See Plans and Pricing |
Poland | 210224 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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