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Gabapentin - Generic Drug Details

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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, 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, Glenmark Generics, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, and Arbor Pharms Llc, and is included in forty-seven NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in seventeen countries.

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

Summary for Generic Name: gabapentin

Tradenames:4
Patents:17
Applicants:33
NDAs:47
Drug Master File Entries: see list26
Suppliers / Packagers: see list102
Bulk Api Vendors: see list93
Clinical Trials: see list102
Patent Applications: see list6,333
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. Form Dosage
<disabled><disabled>CAPSULE;ORAL100MG
<disabled><disabled>CAPSULE;ORAL300MG
<disabled><disabled>CAPSULE;ORAL400MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
GABAPENTIN
gabapentin
TABLET;ORAL200651-001Oct 6, 2011RXNoNo► subscribe► subscribe
Apotex Inc
GABAPENTIN
gabapentin
TABLET;ORAL077894-002Oct 10, 2006RXNoNo► subscribe► subscribe
Teva Pharms
GABAPENTIN
gabapentin
CAPSULE;ORAL075435-003Oct 8, 2004RXNoNo► 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, 19985,084,479*PED► subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-003Dec 30, 19934,024,175► subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-001Dec 30, 19934,087,544*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
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► subscribe
8,529,955Methods of treatment using a gastric retained gabapentin dosage► 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
Canada2464322► subscribe
New Zealand523214► subscribe
European Patent Office2260832► 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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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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