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Last Updated: June 7, 2020

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GRALISE Drug 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in sixteen countries.

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

US ANDA 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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Paragraph IV (Patent) Challenges for GRALISE
Tradename Dosage Ingredient NDA Submissiondate
GRALISE TABLET;ORAL gabapentin 022544 2011-10-31

US Patents and Regulatory Information for GRALISE

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   Start Trial   Start Trial Y   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 022544-001 Jan 28, 2011   Start Trial   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011   Start Trial   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011   Start Trial   Start Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Mallinckrodt
Harvard Business School
Baxter

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