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Serving leading biopharmaceutical companies globally:

Argus Health
Dow
Chinese Patent Office
Boehringer Ingelheim
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Colorcon
US Army
Chubb
Accenture
AstraZeneca

Generated: December 14, 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 Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Pfizer Pharms, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Parke Davis, Aci Healthcare Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Depomed Inc, and Arbor Pharms Llc, and is included in fifty-one 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 eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Apotex IncGABAPENTINgabapentinCAPSULE;ORAL075360-003Apr 6, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncGRALISEgabapentinTABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma LtdGABAPENTINgabapentinTABLET;ORAL200651-002Oct 6, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cspc Ouyi Pharm CoGABAPENTINgabapentinTABLET;ORAL207057-001Oct 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Acella Pharms LlcGABAPENTINgabapentinSOLUTION;ORAL076403-001May 1, 2012AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cspc Ouyi Pharm CoGABAPENTINgabapentinCAPSULE;ORAL075477-002Mar 23, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinTABLET;ORAL020882-002Oct 9, 1998ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Cspc Ouyi Pharm CoGABAPENTINgabapentinCAPSULE;ORAL075477-003Mar 23, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Arbor Pharms LlcHORIZANTgabapentin enacarbilTABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Cspc Ouyi Pharm CoGABAPENTINgabapentinTABLET;ORAL207057-002Oct 26, 2017ABRXNoNo► Subscribe► Subscribe► 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
Parke DavisNEURONTINgabapentinSOLUTION;ORAL021129-001Mar 2, 2000► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinTABLET;ORAL020882-001Oct 9, 1998► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinCAPSULE;ORAL020235-002Dec 30, 1993► Subscribe► Subscribe
Depomed IncGRALISEgabapentinTABLET;ORAL022544-001Jan 28, 2011► Subscribe► Subscribe
Parke DavisNEURONTINgabapentinSOLUTION;ORAL021129-001Mar 2, 2000► Subscribe► Subscribe
Depomed IncGRALISEgabapentinTABLET;ORAL022544-002Jan 28, 2011► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinCAPSULE;ORAL020235-003Dec 30, 1993► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinTABLET;ORAL020882-002Oct 9, 1998► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinCAPSULE;ORAL020235-001Dec 30, 1993► Subscribe► Subscribe
Pfizer PharmsNEURONTINgabapentinTABLET;ORAL020882-002Oct 9, 1998► Subscribe► 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
8,475,813Methods of treatment using a gastric retained gabapentin dosage► 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
8,440,232Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,333,991Gastric retained gabapentin dosage form► Subscribe
8,592,481Gastric retentive gabapentin dosage forms and methods for using same► Subscribe
8,409,613Gastric retained gabapentin dosage form► Subscribe
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► Subscribe
8,231,905Gastric 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
Canada2575555► Subscribe
Canada2635466► Subscribe
Japan2000513028► Subscribe
Japan4083818► Subscribe
China101484153► Subscribe
Japan2009040787► Subscribe
Japan2013006863► Subscribe
Japan2003535886► Subscribe
European Patent Office1446106► Subscribe
Australia2006332690► 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:

Cantor Fitzgerald
Farmers Insurance
Boehringer Ingelheim
Cerilliant
Covington
McKesson
Accenture
Merck
Colorcon
Chinese Patent Office

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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