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Flibanserin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for flibanserin?

Flibanserin is the generic ingredient in one branded drug marketed by Sprout Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flibanserin has seventy-two patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for Generic Name: flibanserin

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list24
Clinical Trials: see list3
Patent Applications: see list363
Drug Prices:see low prices
DailyMed Link:flibanserin at DailyMed

Pharmacology for Ingredient: flibanserin

Mechanism of ActionP-Glycoprotein Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sprout Pharms
ADDYI
flibanserin
TABLET;ORAL022526-001Aug 18, 2015RXYesYes7,151,103► Subscribe ► Subscribe
Sprout Pharms
ADDYI
flibanserin
TABLET;ORAL022526-001Aug 18, 2015RXYesYes7,420,057► SubscribeYY ► Subscribe
Sprout Pharms
ADDYI
flibanserin
TABLET;ORAL022526-001Aug 18, 2015RXYesYes8,227,471► Subscribe ► Subscribe
Sprout Pharms
ADDYI
flibanserin
TABLET;ORAL022526-001Aug 18, 2015RXYesYes► Subscribe► Subscribe
Sprout Pharms
ADDYI
flibanserin
TABLET;ORAL022526-001Aug 18, 2015RXYesYes9,468,639► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: flibanserin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,183,410Stable polymorph of flibanserin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: flibanserin

Country Document Number Estimated Expiration
Denmark1446122► Subscribe
South Korea20090130196► Subscribe
Serbia50742► Subscribe
China1571670► Subscribe
Argentina077416► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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