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Generated: May 22, 2017

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Gabapentin - Generic Drug Details

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

is the generic ingredient in four branded drugs marketed by Sciegen Pharms Inc, Alkem Labs Ltd, Acella Pharms Llc, Invagen Pharms, Ranbaxy, Sun Pharm Inds Ltd, Marksans Pharma, Teva Pharms Usa, Ivax Sub Teva Pharms, Sandoz, Amneal Pharms, Zydus Pharms Usa Inc, Teva, Amneal Pharms Ny, Parke Davis, Teva Pharms, Pfizer Pharms, Mylan Pharms Inc, Sun Pharm Inds, Aci Healthcare Ltd, Depomed Inc, Actavis Elizabeth, Hikma, Aurobindo Pharma Ltd, Alkem, Mylan, Apotex Inc, Taro Pharm, Glenmark Generics, Taro, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, Epic Pharma Llc, and Arbor Pharms Llc, and is included in forty-nine NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has sixty-four patent family members in seventeen countries.

There are twenty-six drug master file entries for gabapentin. One hundred and five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: gabapentin

Drug Master File Entries: see list26
Suppliers / Packagers: see list105
Bulk Api Vendors: see list93
Clinical Trials: see list102
Patent Applications: see list6,382
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gabapentin at DailyMed

Pharmacology for Ingredient: gabapentin

Tentative approvals for GABAPENTIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe600MGTABLET;ORAL
► Subscribe► Subscribe800MGTABLET;ORAL
► Subscribe► Subscribe400MGCAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo6,818,787► SubscribeYY ► Subscribe
Depomed Inc
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes8,252,332► SubscribeY ► Subscribe
Glenmark Generics
TABLET;ORAL077662-001Aug 18, 2006ABRXNoNo► Subscribe► Subscribe
CAPSULE;ORAL090158-001Feb 14, 2011ABRXNoNo► Subscribe► Subscribe
Apotex Inc
TABLET;ORAL077661-004Sep 13, 2006ABRXNoNo► 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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