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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Army
Novartis
Accenture
McKinsey
Federal Trade Commission
McKesson
Citi
Daiichi Sankyo
Baxter

Generated: June 22, 2017

DrugPatentWatch Database Preview

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 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 four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: gabapentin

Tradenames:4
Patents:18
Applicants:36
NDAs:49
Drug Master File Entries: see list26
Suppliers / Packagers: see list104
Bulk Api Vendors: see list93
Clinical Trials: see list312
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
Ivax Sub Teva Pharms
GABAPENTIN
gabapentin
TABLET;ORAL076017-004Apr 29, 2005ABRXNoNo► Subscribe► Subscribe
Ivax Sub Teva Pharms
GABAPENTIN
gabapentin
CAPSULE;ORAL075477-003Mar 23, 2005DISCNNoNo► Subscribe► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo8,686,034► Subscribe ► Subscribe
Ranbaxy
GABAPENTIN
gabapentin
TABLET;ORAL076605-002Sep 14, 2005DISCNNoNo► Subscribe► Subscribe
Ivax Sub Teva Pharms
GABAPENTIN
gabapentin
CAPSULE;ORAL075477-002Mar 23, 2005DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms
NEURONTIN
gabapentin
TABLET;ORAL020882-001Oct 9, 19984,087,544*PED► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
TABLET;ORAL020882-001Oct 9, 19985,084,479*PED► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-003Dec 30, 19935,084,479*PED► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
TABLET;ORAL020882-002Oct 9, 19985,084,479*PED► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-001Dec 30, 19934,894,476*PED► Subscribe
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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
8,333,991Gastric retained gabapentin dosage form► Subscribe
8,440,232Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,475,813Methods of treatment using a gastric retained gabapentin dosage► Subscribe
7,612,112Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,409,613Gastric 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
Australia2001239893► Subscribe
New Zealand523214► Subscribe
Japan2008508317► Subscribe
Hong Kong1027298► Subscribe
Japan2016166239► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Harvard Business School
Deloitte
US Department of Justice
Johnson and Johnson
Medtronic
Healthtrust
Accenture
Moodys
McKinsey

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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