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

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Julphar
McKesson
Accenture
Daiichi Sankyo
Merck
Dow
Fuji
Chubb

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021055

« Back to Dashboard

NDA 021055 describes TARGRETIN, which is a drug marketed by Valeant Luxembourg and is included in two NDAs. It is available from two suppliers. Additional details are available on the TARGRETIN profile page.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
Summary for 021055
Tradename:TARGRETIN
Applicant:Valeant Luxembourg
Ingredient:bexarotene
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021055
Ingredient-typeRetinoids
Suppliers and Packaging for NDA: 021055
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TARGRETIN bexarotene CAPSULE;ORAL 021055 NDA Valeant Pharmaceuticals North America LLC 0187-5526 N 0187-5526-75
TARGRETIN bexarotene CAPSULE;ORAL 021055 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-003 N 68682-003-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Dec 29, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 29, 2018
Regulatory Exclusivity Use:REVISES THE CLINICAL TRIALS SECTION OF THE PRESCRIBING INFORMATION TO INCORPORATE THE RESULTS FROM STUDY E7273-G000-401 ENTITLED 'PHASE IV RANDOMIZED STUDY OF TWO DOSE LEVELS OF TARGRETIN CAPSULES IN SUBJECTS WITH REFRACTORY CUTANEOUS T-CELL LYMPHOMA'

Expired US Patents for NDA 021055

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Sign Up ➤ Sign Up
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Sign Up ➤ Sign Up
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Sign Up ➤ Sign Up
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ 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:

Daiichi Sankyo
Fish and Richardson
Johnson and Johnson
Baxter
Medtronic
AstraZeneca
Julphar
Farmers Insurance
Argus Health

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.