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 Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Norvium Bioscience, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Viatris, Acella Pharms Llc, Amneal Pharms, Annora Pharma, Belcher, Mission Pharmacal, Pai Holdings Pharm, Rubicon, Abon Pharms Llc, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Humanwell, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms, Zydus Pharms Usa Inc, Almatica, and Azurity, and is included in seventy-one NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has twenty-four patent family members in nine countries.

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

Summary for gabapentin

International Patents:	24
US Patents:	6
Tradenames:	4
Applicants:	49
NDAs:	71
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	78
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	518
Patent Applications:	7,124
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

See drug prices for gabapentin

Drug Sales Revenue Trends for gabapentin

See drug sales revenues for gabapentin

Recent Clinical Trials for gabapentin

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

Sponsor	Phase
University of Miami	Phase 3
Tanta University	N/A
Beni-Suef University	Phase 2

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	600MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	600MG	TABLET, 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

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for gabapentin

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	GABAPENTIN	gabapentin	TABLET;ORAL	076017-003	Apr 28, 2004	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	GABAPENTIN	gabapentin	TABLET;ORAL	205807-002	Mar 10, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	GABAPENTIN	gabapentin	CAPSULE;ORAL	214956-001	May 10, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	⤷ Sign Up	⤷ Sign Up
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	⤷ Sign Up	⤷ Sign Up
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for gabapentin

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Country	Patent Number	Title	Estimated Expiration
Denmark	1439825		⤷ Sign Up
China	101484153		⤷ Sign Up
Canada	2635466		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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