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Last Updated: March 28, 2024

TAMIFLU Drug Patent 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. Thirty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tamiflu

A generic version of TAMIFLU was approved as oseltamivir phosphate by NATCO on August 3rd, 2016.

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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

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SponsorPhase
Genentech, Inc.Phase 4
Weill Medical College of Cornell UniversityPhase 4
Laboratorios Andromaco S.A.Phase 1

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Pharmacology for TAMIFLU
Drug ClassNeuraminidase Inhibitor
Mechanism of ActionNeuraminidase Inhibitors
Paragraph IV (Patent) Challenges for TAMIFLU
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TAMIFLU for Oral Suspension oseltamivir phosphate 6 mg/mL 021246 1 2015-06-18
TAMIFLU Capsules oseltamivir phosphate 30 mg and 45 mg 021087 1 2011-08-02
TAMIFLU Capsules oseltamivir phosphate 75 mg 021087 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007 ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 ⤷  Try a Trial ⤷  Try a Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TAMIFLU

See the table below for patents covering TAMIFLU around the world.

Country Patent Number Title Estimated Expiration
Germany 10299052 ⤷  Try a Trial
Japan 2002161074 NOVEL SELECTIVE INHIBITOR OF VIRAL OR BACTERIAL NEURAMINIDASE ⤷  Try a Trial
China 1147813 ⤷  Try a Trial
Russian Federation 2181357 COMPOSITION OF SELECTIVE INHIBITORS OF VIRAL OR BACTERIAL NEURAMINIDASES (VARIANTS), COMPOUND AND METHOD OF TREATMENT OR PROPHYLAXIS OF INFLUENZA DISEASE ⤷  Try a Trial
Mexico 9706496 NUEVOS INHIBIDORES SELECTIVOS DE LAS NEUROAMINIDASAS VIRALES O BACTERIANAS. (NOVEL SELECTIVE INHIBITORS OF VIRAL OR BACTERIAL NEURAMINIDASES.) ⤷  Try a Trial
China 1733707 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAMIFLU

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

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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 verification 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.