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Details for New Drug Application (NDA): 021257

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NDA 021257 describes TRAVATAN, which is a drug marketed by Alcon Pharms Ltd and Novartis Pharms Corp and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRAVATAN profile page.

The generic ingredient in TRAVATAN is travoprost. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the travoprost profile page.

Summary for NDA: 021257

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 16, 2001TE:RLD:Yes

Expired Orange Book Patents for NDA: 021257

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
TRAVATAN
travoprost
SOLUTION/DROPS;OPHTHALMIC021257-001Mar 16, 20015,510,383► Subscribe
Alcon Pharms Ltd
TRAVATAN
travoprost
SOLUTION/DROPS;OPHTHALMIC021257-001Mar 16, 20015,631,287► Subscribe
Alcon Pharms Ltd
TRAVATAN
travoprost
SOLUTION/DROPS;OPHTHALMIC021257-001Mar 16, 20016,011,062► Subscribe
Alcon Pharms Ltd
TRAVATAN
travoprost
SOLUTION/DROPS;OPHTHALMIC021257-001Mar 16, 20015,889,052► Subscribe
Alcon Pharms Ltd
TRAVATAN
travoprost
SOLUTION/DROPS;OPHTHALMIC021257-001Mar 16, 20015,849,792► 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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