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Last Updated: January 27, 2023

Gabapentin - Generic Drug Details


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What are the generic sources for gabapentin and what is the scope of patent protection?

Gabapentin is the generic ingredient in four branded drugs marketed by ACI, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Viatris, Acella Pharms Llc, Akorn, Amneal Pharms, Belcher, Pai Holdings Pharm, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, 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 Azurity, and is included in fifty-eight NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has seventy-six patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-two 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

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SponsorPhase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2/Phase 3
Boston Medical CenterPhase 2/Phase 3
University of IowaPhase 4

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing600MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing600MGTABLET, EXTENDED RELEASE;ORAL

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 Strength NDA ANDAs Submitted Submissiondate
GRALISE Tablets gabapentin 300 mg and 600 mg 022544 1 2011-10-31

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
Granules GABAPENTIN gabapentin CAPSULE;ORAL 075360-003 Apr 6, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Inds Ltd GABAPENTIN gabapentin CAPSULE;ORAL 077242-002 Aug 24, 2006 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cspc Ouyi GABAPENTIN gabapentin TABLET;ORAL 207057-002 Oct 26, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
>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.