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Serving 500+ biopharmaceutical companies globally:

Julphar
Express Scripts
Queensland Health
Federal Trade Commission
Cantor Fitzgerald
Daiichi Sankyo
Deloitte
Chubb
McKesson
Baxter

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021481

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NDA 021481 describes FUZEON, which is a drug marketed by Roche and is included in one NDA. It is available from one supplier. Additional details are available on the FUZEON profile page.

The generic ingredient in FUZEON is enfuvirtide. One supplier is listed for this compound. Additional details are available on the enfuvirtide profile page.

Summary for NDA: 021481

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

Suppliers and Packaging for NDA: 021481

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUZEON
enfuvirtide
INJECTABLE;SUBCUTANEOUS 021481 NDA Genentech, Inc. 0004-0381 0004-0381-40 1 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength90MG/VIAL
Approval Date:Mar 13, 2003TE:RLD:Yes

Expired Orange Book Patents for NDA: 021481

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
FUZEON
enfuvirtide
INJECTABLE;SUBCUTANEOUS021481-001Mar 13, 20035,464,933► Subscribe
Roche
FUZEON
enfuvirtide
INJECTABLE;SUBCUTANEOUS021481-001Mar 13, 20036,475,491► Subscribe
Roche
FUZEON
enfuvirtide
INJECTABLE;SUBCUTANEOUS021481-001Mar 13, 20036,133,418► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Cipla
Citi
UBS
US Army
Johnson and Johnson
Daiichi Sankyo
Fuji
Express Scripts

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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