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Generated: September 21, 2018

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 two suppliers. 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-eight drug master file entries for this compound. One hundred and eleven 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 Depomed, Inc. 13913-004 13913-004-19 90 TABLET, FILM COATED in 1 BOTTLE (13913-004-19)
GRALISE gabapentin TABLET;ORAL 022544 NDA Depomed, Inc. 13913-004 13913-004-91 19 TABLET, FILM COATED in 1 BOTTLE (13913-004-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 28, 2011TE:BXRLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2018
Regulatory Exclusivity Use:FOR THE MANAGEMENT OF POSTHERPETIC NEURALGIA
Patent:➤ Sign UpPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 25, 2021Product Flag?YSubstance Flag?Delist Request?

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 ➤ Sign Up ➤ Sign Up
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Assertio 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

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Healthtrust
Farmers Insurance
Chinese Patent Office
Cerilliant
Julphar
Citi
Baxter
Argus Health

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