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Gabapentinis the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cspc Ouyi, Granules, Graviti Pharms, 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-seven NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Gabapentin has eighty-seven patent family members in forty-seven countries.
There are twenty-nine drug master file entries for gabapentin. Seventy-six suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for gabapentin
|Drug Master File Entries:||29|
|Finished Product Suppliers / Packagers:||76|
|Raw Ingredient (Bulk) Api Vendors:||136|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for gabapentin|
|Drug Sales Revenues:||Drug sales revenues for gabapentin|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for gabapentin|
|What excipients (inactive ingredients) are in gabapentin?||gabapentin excipients list|
|DailyMed Link:||gabapentin at DailyMed|
Recent Clinical Trials for gabapentin
Identify potential brand extensions & 505(b)(2) entrants
|David Cochran||Phase 4|
|Eagles Autism Foundation||Phase 4|
|Thomas Jefferson University||Phase 3|
Generic filers with tentative approvals for GABAPENTIN
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
|Drug Class||Anti-epileptic Agent |
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Invagen Pharms||GABAPENTIN||gabapentin||CAPSULE;ORAL||090705-001||Dec 30, 2009||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Tris Pharma Inc||GABAPENTIN||gabapentin||SOLUTION;ORAL||091286-001||Mar 14, 2016||AA||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Sandoz||GABAPENTIN||gabapentin||TABLET;ORAL||076120-001||Jan 27, 2006||DISCN||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Almatica||GRALISE||gabapentin||TABLET;ORAL||022544-001||Jan 28, 2011||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Upjohn||NEURONTIN||gabapentin||TABLET;ORAL||020882-001||Oct 9, 1998||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Upjohn||NEURONTIN||gabapentin||SOLUTION;ORAL||021129-001||Mar 2, 2000||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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