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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022544

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NDA 022544 describes GRALISE, which is a drug marketed by Assertio and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GRALISE profile page.

The generic ingredient in GRALISE is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 022544
Tradename:GRALISE
Applicant:Assertio
Ingredient:gabapentin
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 022544
Suppliers and Packaging for NDA: 022544
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRALISE gabapentin TABLET;ORAL 022544 NDA Assertio Therapeutics, Inc. 13913-004 13913-004-19 90 TABLET, FILM COATED in 1 BOTTLE (13913-004-19)
GRALISE gabapentin TABLET;ORAL 022544 NDA Assertio Therapeutics, Inc. 13913-004 13913-004-91 19 TABLET, FILM COATED in 1 BOTTLE (13913-004-91)
Paragraph IV (Patent) Challenges for 022544
Tradename Dosage Ingredient NDA Submissiondate
GRALISE TABLET;ORAL gabapentin 022544 2011-10-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 28, 2011TE:BXRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 25, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Expired US Patents for NDA 022544

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011   Start Trial   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011   Start Trial   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011   Start Trial   Start Trial
Assertio 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

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