Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Fuji
Baxter
Chubb
Medtronic
Cipla
Julphar
Chinese Patent Office
Federal Trade Commission
US Department of Justice

Generated: August 23, 2017

DrugPatentWatch Database Preview

Gabapentin - Generic Drug Details

« Back to Dashboard

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-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

Tradenames:4
Patents:17
Applicants:36
NDAs:49
Drug Master File Entries: see list26
Suppliers / Packagers: see list105
Bulk Api Vendors: see list93
Clinical Trials: see list318
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
► 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
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Actavis Elizabeth
GABAPENTIN
gabapentin
TABLET;ORAL075694-002Oct 21, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
GABAPENTIN
gabapentin
CAPSULE;ORAL076537-002Jun 30, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
GABAPENTIN
gabapentin
TABLET;ORAL090335-002Jun 1, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-002Dec 30, 1993► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-003Dec 30, 1993► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-002Dec 30, 1993► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
TABLET;ORAL020882-002Oct 9, 1998► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-002Dec 30, 1993► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► Subscribe
8,529,955Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,580,303Gastric retained gabapentin dosage form► Subscribe
7,612,112Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,592,481Gastric retentive gabapentin dosage forms and methods for using same► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: gabapentin

Country Document Number Estimated Expiration
Austria536863► Subscribe
Japan2013006863► Subscribe
Israel153464► Subscribe
Canada2409999► Subscribe
Portugal1294363► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Cipla
Chubb
Cantor Fitzgerald
Johnson and Johnson
Colorcon
Boehringer Ingelheim
Cerilliant
Covington
AstraZeneca

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot