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Generated: May 29, 2017

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Pregabalin - Generic Drug Details

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What are the generic sources for pregabalin and what is the scope of pregabalin patent protection?

is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has sixty-five patent family members in thirty-one countries.

There are thirty-six drug master file entries for pregabalin. Thirteen suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Summary for Generic Name: pregabalin

Drug Master File Entries: see list36
Suppliers / Packagers: see list13
Bulk Api Vendors: see list63
Clinical Trials: see list80
Patent Applications: see list6,301
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pregabalin at DailyMed

Tentative approvals for PREGABALIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe25MGCAPSULE; ORAL
► Subscribe► Subscribe300MGCAPSULE; ORAL
► Subscribe► Subscribe225MGCAPSULE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo6,001,876► SubscribeY ► Subscribe
Pf Prism Cv
SOLUTION;ORAL022488-001Jan 4, 2010RXYesYesRE41920► Subscribe ► Subscribe
Pf Prism Cv
CAPSULE;ORAL021446-002Dec 30, 2004RXYesNo► Subscribe► Subscribe
Pf Prism Cv
CAPSULE;ORAL021446-001Dec 30, 2004RXYesNoRE41920► Subscribe ► Subscribe
Pf Prism Cv
CAPSULE;ORAL021446-005Dec 30, 2004RXYesNo► Subscribe► Subscribe
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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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