Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
UBS
Deloitte
Medtronic
AstraZeneca
Cipla
Fish and Richardson
Colorcon
McKinsey
Mallinckrodt

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022544

« Back to Dashboard

NDA 022544 describes GRALISE, which is a drug marketed by Depomed Inc 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 seven suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 022544
Tradename:GRALISE
Applicant:Depomed Inc
Ingredient:gabapentin
Patents:7
Therapeutic Class:Anticonvulsants
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 N 13913-004-91
GRALISE gabapentin TABLET;ORAL 022544 NDA Depomed, Inc. 13913-004 N 13913-004-19

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
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Medtronic
Healthtrust
Chubb
Harvard Business School
McKinsey
QuintilesIMS
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot