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-five 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.
Summary for GRALISE
International Patents: | 24 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 143 |
Clinical Trials: | 18 |
Patent Applications: | 4,753 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Massachusetts General Hospital | Phase 4 |
University of California, Davis | Phase 3 |
University of Balamand | Phase 4 |
Pharmacology for GRALISE
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
Gastric retained gabapentin dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Gastric retained gabapentin dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
Gastric retained gabapentin dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
Gastric retained gabapentin dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Portugal | 998271 | ⤷ Try a Trial | |
Germany | 69831335 | ⤷ Try a Trial | |
Taiwan | 200800155 | ⤷ Try a Trial | |
Mexico | PA04003946 | METODOS DE TRATAMIENTO USANDO UNA FORMA DE DOSIS DE GABAPENTINA DE RETENCION GASTRICA. (METHODS OF TREATMENT USING A GASTRIC RETAINED GABAPENTIN DOSAGE.) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |