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Last Updated: May 24, 2022

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

See all TAMIFLU clinical trials

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

TAMIFLU is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting TAMIFLU

INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CAPSULE;ORAL 021087-001 Oct 27, 1999 See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007 See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007 See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 See Plans and Pricing See Plans and Pricing
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007 See Plans and Pricing See Plans and Pricing
>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
Hungary 228450 NOVEL SELECTIVE INHIBITORS OF VIRAL OR BACTERIAL NEURAMINIDASES See Plans and Pricing
China 1185223 See Plans and Pricing
China 1733707 See Plans and Pricing
Japan 2006036770 NOVEL SELECTIVE INHIBITOR TO VIRUS OR BACTERIAL NEURAMINIDASE See Plans and Pricing
New Zealand 520724 Tetrahydro-pyridine compounds for inhibiting neuraminidase and treating influenza neuraminidase See Plans and Pricing
Greece 3033914 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAMIFLU

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

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Boehringer Ingelheim
AstraZeneca
Dow
Mallinckrodt

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