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Serving leading biopharmaceutical companies globally:

Chubb
Novartis
Cantor Fitzgerald
Express Scripts
Colorcon
Julphar
US Army
Johnson and Johnson
Covington
Argus Health

Generated: October 19, 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?

Gabapentin
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 Pharms Ltd, 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 seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: gabapentin

US Patents:17
Tradenames:4
Applicants:36
NDAs:49
Drug Master File Entries: see list28
Suppliers / Packagers: see list107
Bulk Api Vendors: see list93
Clinical Trials: see list322
Patent Applications: see list6,038
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
u► Subscribe600MGTABLET;ORAL
u► Subscribe800MGTABLET;ORAL
u► Subscribe400MGCAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms
GABAPENTIN
gabapentin
TABLET;ORAL076017-002Apr 28, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
GABAPENTIN
gabapentin
TABLET;ORAL075827-001Dec 15, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
GABAPENTIN
gabapentin
TABLET;ORAL205807-002Mar 10, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
GABAPENTIN
gabapentin
SOLUTION;ORAL202024-001Mar 23, 2012AARXNoNo► Subscribe► Subscribe► Subscribe
Alkem Labs Ltd
GABAPENTIN
gabapentin
TABLET;ORAL206402-001Dec 23, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
GABAPENTIN
gabapentin
TABLET;ORAL090335-002Jun 1, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
GABAPENTIN
gabapentin
CAPSULE;ORAL075360-001Apr 6, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Ranbaxy
GABAPENTIN
gabapentin
TABLET;ORAL076605-001Sep 14, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Parke Davis
NEURONTIN
gabapentin
SOLUTION;ORAL021129-001Mar 2, 2000AARXYesYes► Subscribe► SubscribeY► Subscribe
Alkem
GABAPENTIN
gabapentin
CAPSULE;ORAL090858-002Dec 17, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gabapentin

Non-Orange Book Patents for Generic Ingredient: gabapentin

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
8,409,613Gastric retained gabapentin dosage form► Subscribe
7,612,112Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,529,955Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,580,303Gastric retained gabapentin dosage form► Subscribe
8,231,905Gastric retained gabapentin dosage form► Subscribe
8,333,991Gastric retained gabapentin dosage form► Subscribe
8,440,232Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,119,166Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,475,813Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► 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: gabapentin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9855107► Subscribe
Spain2213108► Subscribe
Japan4083818► Subscribe
Germany60101581► Subscribe
Australia8138698► Subscribe
European Patent Office2266539► Subscribe
South Korea20030023876► Subscribe
Denmark1439825► Subscribe
World Intellectual Property Organization (WIPO)2006015294► Subscribe
European Patent Office1446106► 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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Serving leading biopharmaceutical companies globally:

Moodys
Cipla
Argus Health
QuintilesIMS
Queensland Health
Fuji
Farmers Insurance
Mallinckrodt
Colorcon
Dow

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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