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Last Updated: May 8, 2021

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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, Macleods Pharms Ltd, MSN, Mylan, Natco Pharma Ltd, Nesher Pharms, Strides Pharma, Sunshine, Roche, Ajanta Pharma Ltd, Alvogen Pine Brook, Amneal Pharms Ny, and Teva Pharms Usa, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for oseltamivir phosphate
Recent Clinical Trials for oseltamivir phosphate

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

SponsorPhase
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Phase 1
Austarpharma, LLCPhase 1
Institute of Liver and Biliary Sciences, IndiaPhase 2

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
Strides Pharma OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209421-003 Jun 8, 2018 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 210157-002 Jan 21, 2021 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Nesher Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 209113-001 Sep 14, 2017 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Amneal Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209093-003 May 17, 2017 AB RX 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 oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Get Started for $10   Get Started for $10
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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