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Last Updated: May 26, 2022

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 are five patents 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-eight 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

See drug prices for GRALISE

Drug Sales Revenue Trends for GRALISE

See drug sales revenues for GRALISE

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

Anatomical Therapeutic Chemical (ATC) Classes 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 five US patents.

Patents protecting GRALISE

Methods of treatment using a gastric retained gabapentin dosage
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Gastric retained gabapentin dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gastric retained gabapentin dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Gastric retained gabapentin dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Gastric retained gabapentin dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 GRALISE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
>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
Japan 4083818 See Plans and Pricing
Germany 60101581 See Plans and Pricing
Canada 2290624 FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE ARETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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AstraZeneca
Mallinckrodt
Harvard Business School
Baxter

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