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 12^th, 2003.

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Summary for GRALISE

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	18
Patent Applications:	4,662
Drug Prices:	Drug price information for GRALISE
Drug Sales Revenues:	Drug sales revenues for GRALISE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GRALISE
What excipients (inactive ingredients) are in GRALISE?	GRALISE excipients list
DailyMed Link:	GRALISE at DailyMed

Drug patent expirations by year for GRALISE

Recent Clinical Trials for GRALISE

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
University of California, Davis	Phase 3
University of Balamand	Phase 4

See all GRALISE clinical trials

Pharmacology for GRALISE

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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

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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
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
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	AB2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-005	Apr 18, 2023		RX	Yes	Yes	⤷ 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

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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
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	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	022544-002	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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1439825	MÉTHODES DE TRAITEMENT À L'AIDE D'UN DOSAGE DE GABAPENTINE À RETENUE GASTRIQUE (METHODS OF TREATMENT USING A GASTRIC RETAINED GABAPENTIN DOSAGE FORM)	⤷ Sign Up
Portugal	1294363		⤷ Sign Up
Mexico	2007001187	FORMA DE DOSIFICACION RETENIDA GASTRICA DE GABAPENTINA. (A GASTRIC RETAINED DOSAGE FORM OF GABAPENTIN.)	⤷ Sign Up
Taiwan	200800155		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03035040		⤷ Sign Up
World Intellectual Property Organization (WIPO)	0197783		⤷ Sign Up
Israel	153464	CONTROLLED RELEASE ORAL DRUG DOSAGE FORM	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration