Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Boehringer Ingelheim
Moodys
Mallinckrodt
Colorcon

Last Updated: October 1, 2022

Details for New Drug Application (NDA): 022544


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 022544 describes GRALISE, which is a drug marketed by Almatica and is included in one NDA. It is available from two suppliers. There are five 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. Seventy-four suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 022544
Tradename:GRALISE
Applicant:Almatica
Ingredient:gabapentin
Patents:5
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 28, 2011TE:BXRLD:Yes
Patent:See Plans and PricingPatent 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
Patent:See Plans and PricingPatent Expiration:Oct 25, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Oct 25, 2022Product Flag?YSubstance 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
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Moodys
Merck
Medtronic
Harvard Business School

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 verification 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.