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Last Updated: June 26, 2022

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, Epic Pharma Llc, Hetero Labs Ltd Iii, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Roche, Ajanta Pharma Ltd, Alvogen Pine Brook, Amneal Pharms Ny, Aptapharma Inc, Hetero Labs Ltd V, Leading Pharma Llc, and Teva Pharms Usa, and is included in twenty-six 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.

Summary for oseltamivir phosphate
Recent Clinical Trials for oseltamivir phosphate

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

SponsorPhase
Laboratorios Andromaco S.A.Phase 1
Sunshine Lake Pharma Co., Ltd.Phase 1
The Affiliated Hospital of Qingdao UniversityPhase 1

See all oseltamivir phosphate clinical trials

Pharmacology for oseltamivir phosphate
Medical Subject Heading (MeSH) Categories for oseltamivir phosphate
Anatomical Therapeutic Chemical (ATC) Classes for oseltamivir phosphate
Paragraph IV (Patent) Challenges for OSELTAMIVIR PHOSPHATE
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 oseltamivir phosphate

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 021087-001 Oct 27, 1999 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 211125-001 Feb 27, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 208578-003 Feb 24, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 209113-001 Sep 14, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aptapharma Inc OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 212858-001 Aug 30, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 210157-001 Jan 21, 2021 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 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 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
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 021087-002 Jul 2, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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