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Last Updated: March 29, 2024

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 Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Roche, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aptapharma Inc, Chemistry Hlth, Hetero Labs Ltd V, and Teva Pharms Usa, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oseltamivir phosphate. Thirty-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
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
Drug ClassNeuraminidase Inhibitor
Mechanism of ActionNeuraminidase Inhibitors
Medical Subject Heading (MeSH) Categories 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
Hetero Labs Ltd Iii OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209438-001 Feb 23, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 210157-002 Jan 21, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Invagen Pharms OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 217467-003 Oct 3, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 212544-002 May 20, 2020 AB RX 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 OSELTAMIVIR PHOSPHATE

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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