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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020646

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NDA 020646 describes GABITRIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the GABITRIL profile page.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for 020646

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 020646

Suppliers and Packaging for NDA: 020646

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABITRIL tiagabine hydrochloride TABLET;ORAL 020646 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-5030 0093-5030-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)
GABITRIL tiagabine hydrochloride TABLET;ORAL 020646 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-5031 0093-5031-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020646

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-005Apr 16, 1999► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
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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.

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