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Last Updated: August 9, 2020

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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 patent protection?

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 India Ltd, 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, Pfizer Pharms, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Tris Pharma Inc, Vistapharm, Parke Davis, 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-five 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-three suppliers are listed for this compound. There is one tentative approval 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
State University of New York at BuffaloPhase 3
National Center for Advancing Translational Science (NCATS)Phase 2
University of California, San DiegoPhase 2

See all GABAPENTIN clinical trials

Generic filers with tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial600MGTABLET; ORAL
  Start Trial  Start Trial300MGTABLET; 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 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   Start Trial
Jiangsu Hengrui Med GABAPENTIN gabapentin CAPSULE;ORAL 091008-001 Oct 26, 2017 DISCN No 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
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Aci Healthcare Ltd GABAPENTIN gabapentin CAPSULE;ORAL 206943-002 May 14, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth GABAPENTIN gabapentin CAPSULE;ORAL 075350-001 Sep 12, 2003 AB RX No No   Start Trial   Start Trial   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
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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