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Last Updated: August 13, 2020

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Oseltamivir phosphate - Generic Drug Details

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What are the generic sources for oseltamivir phosphate and what is the scope of freedom to operate?

Oseltamivir phosphate is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Amneal Pharms, Hetero Labs Ltd Iii, Lupin Atlantis, Macleods Pharms Ltd, MSN, Natco Pharma Ltd, Nesher Pharms, Strides Pharma, Sunshine Lake, Roche, Ajanta Pharma Ltd, Alvogen Pine Brook, Amneal Pharms Ny, and Teva Pharms Usa, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oseltamivir phosphate. Twenty-three suppliers are listed for this compound.

Recent Clinical Trials for oseltamivir phosphate

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

SponsorPhase
Institute of Liver and Biliary Sciences, IndiaPhase 2
Shehnoor AzharPhase 3
Federal Task Force on Science & Technology notified by Government of PakistanPhase 3

See all oseltamivir phosphate clinical trials

Medical Subject Heading (MeSH) Categories for oseltamivir phosphate
Paragraph IV (Patent) Challenges for OSELTAMIVIR PHOSPHATE
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 oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nesher Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 209113-001 Sep 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 202595-002 Aug 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 211823-002 Jun 24, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209438-001 Feb 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sunshine Lake OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 212739-003 Mar 4, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 DISCN No No   Start Trial   Start Trial   Start 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 oseltamivir phosphate

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

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