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Last Updated: June 14, 2024

GRALISE Drug Patent Profile


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When do Gralise patents expire, and what generic alternatives are available?

Gralise is a drug marketed by Almatica and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in nine countries.

The generic ingredient in GRALISE is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gralise

A generic version of GRALISE was approved as gabapentin by ACTAVIS ELIZABETH on September 12th, 2003.

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Drug patent expirations by year for GRALISE
Drug Prices for GRALISE

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Drug Sales Revenue Trends for GRALISE

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Recent Clinical Trials for GRALISE

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

SponsorPhase
Massachusetts General HospitalPhase 4
University of California, DavisPhase 3
University of BalamandPhase 4

See all GRALISE clinical trials

Pharmacology for GRALISE
Paragraph IV (Patent) Challenges for GRALISE
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 GRALISE

GRALISE is protected by one US patents.

Patents protecting GRALISE

Methods of treatment using a gastric retained gabapentin dosage
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 AB2 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Almatica GRALISE gabapentin TABLET;ORAL 022544-004 Apr 18, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Almatica GRALISE gabapentin TABLET;ORAL 022544-003 Apr 18, 2023 RX Yes 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 GRALISE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Sign Up ⤷  Sign Up
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Sign Up ⤷  Sign Up
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GRALISE

See the table below for patents covering GRALISE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03035177 ⤷  Sign Up
European Patent Office 1773311 ⤷  Sign Up
European Patent Office 2266539 ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.