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GRALISE Drug Profile
» See Plans and Pricing
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. Sixty-nine 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.
Summary for GRALISE
International Patents: | 54 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 132 |
Clinical Trials: | 10 |
Patent Applications: | 4,239 |
Formulation / Manufacturing: | see details |
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 |



Recent Clinical Trials for GRALISE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Davis | Phase 3 |
University of Balamand | Phase 4 |
National Cancer Institute (NCI) | N/A |
Pharmacology for GRALISE
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 | |||
>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 | 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 |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | Start Trial | Start Trial |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GRALISE
Country | Patent Number | Estimated Expiration |
---|---|---|
Germany | 60101581 | Start Trial |
Spain | 2213108 | Start Trial |
Mexico | PA02012614 | Start Trial |
South Korea | 100716756 | Start Trial |
Hong Kong | 1027298 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |