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Last Updated: April 14, 2021

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Gabapentin - Generic Drug Details

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What are the generic sources for gabapentin and what is the scope of freedom to operate?

Gabapentin is the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Upjohn, Acella Pharms Llc, Akorn, Amneal Pharms, Tris Pharma Inc, Vistapharm, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Almatica, and Arbor Pharms Llc, and is included in fifty-six NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has one hundred and six patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for gabapentin

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Drug Sales Revenue Trends for gabapentin

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Recent Clinical Trials for gabapentin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Western University, CanadaPhase 3
Brittany KiracofePhase 4
Mahidol UniversityN/A

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET; ORAL
  Start Trial  Start Trial600MGTABLET; ORAL
  Start Trial  Start TrialUNKNOWNUNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for gabapentin
Paragraph IV (Patent) Challenges for GABAPENTIN
Tradename Dosage Ingredient NDA Submissiondate
GRALISE TABLET;ORAL gabapentin 022544 2011-10-31
NEURONTIN SOLUTION;ORAL gabapentin 021129
NEURONTIN CAPSULE;ORAL gabapentin 020235
NEURONTIN TABLET;ORAL gabapentin 020882

US Patents and Regulatory Information for gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Ltd GABAPENTIN gabapentin TABLET;ORAL 077525-002 Aug 24, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Upjohn NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993 AB RX Yes No   Start Trial   Start Trial   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993   Start Trial   Start Trial
Upjohn NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998   Start Trial   Start Trial
Upjohn NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993   Start Trial   Start Trial
Upjohn NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.