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Last Updated: May 6, 2021

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TAMIFLU Drug Profile

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When do Tamiflu patents expire, and when can generic versions of Tamiflu launch?

Tamiflu is a drug marketed by Roche and is included in two NDAs.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

Drug patent expirations by year for TAMIFLU
Drug Prices for TAMIFLU

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Drug Sales Revenue Trends for TAMIFLU

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Recent Clinical Trials for TAMIFLU

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Austarpharma, LLCPhase 1
Medical Research Council, South AfricaPhase 2/Phase 3
Texas Tech University Health Sciences CenterPhase 2/Phase 3

See all TAMIFLU clinical trials

Paragraph IV (Patent) Challenges for TAMIFLU
Tradename Dosage Ingredient NDA Submissiondate
TAMIFLU FOR SUSPENSION;ORAL oseltamivir phosphate 021246 2015-06-18
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2011-08-02
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2010-11-15

US Patents and Regulatory Information for TAMIFLU

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TAMIFLU

Supplementary Protection Certificates for TAMIFLU

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0759917 38/2002 Austria   Get Started for $10 PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620
0759917 SPC031/2002 Ireland   Get Started for $10 SPC031/2002: 20021107, EXPIRES: 20160226
0759917 90991 Luxembourg   Get Started for $10
0759917 0290024-9 Sweden   Get Started for $10
0759917 CA 2002 00027 Denmark   Get Started for $10
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
Boehringer Ingelheim
AstraZeneca
Dow
Mallinckrodt

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