Oseltamivir Phosphate

Treats acute, uncomplicated influenza A and B. Sold as Tamiflu. Every FDA application for this active ingredient: 2 branded and 37 generic.

As of Nov 15, 2026, FDA lists 39 applications for Oseltamivir Phosphate (sold as Tamiflu), first approved Oct 27, 1999, with 11 new uses approved and 0 published complete response letters.

First approved: Oct 27, 1999
Applications: 39
New uses approved: 11
Complete response letters: 0
Medicare spending, 2025: $40.0M
First approved in the EU: Jun 20, 2002

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Oseltamivir Phosphate	Part D	$39.9M	+113%	1,198,541
Tamiflu	Part D	$100K	+77%	961

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

OSELTAMIVIR 6 MG/ML SUSPENSION: $0.155 per MLGeneric · -6% in a year
TAMIFLU 6 MG/ML SUSPENSION: $2.43 per MLBrand · +0% in a year
TAMIFLU 75 MG CAPSULE: $14.52 per unitBrand · -1% in a year

Approvals in the EU (EMA)

First approved in the EU 32 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ebilfumin, genericActavis Group PTC ehf · May 22, 2014
Tamiflu, new substanceRoche Registration GmbH · Jun 20, 2002

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

TamifluA drug with a new additional dosage for newborns and infants for the treatment of influenza A or B virus infection. · Chugai Pharmaceutical Co., Ltd. · Mar 24, 2017
TamifluDrugs with a new additional indication and a new dosage for prophylaxis of influenza A or B virus infections. · Chugai Pharmaceutical Co., Ltd. · Dec 18, 2009

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
A/Texas Flu ChallengeInfluenza · Emory University	Phase 1	Recruiting	Dec 31, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 27, 1999	TamifluNDA 21087 · New molecular entity	Roche	63	Marketed
Dec 14, 2000	TamifluNDA 21246 · New dosage form	Roche	47	Marketed
Aug 3, 2016	Oseltamivir PhosphateANDA 202595	Natco	3	Marketed
Feb 24, 2017	Oseltamivir PhosphateANDA 208578	Zydus Pharms	5	Marketed
May 17, 2017	Oseltamivir PhosphateANDA 209093	Amneal Pharms	0	Marketed
Sep 14, 2017	Oseltamivir PhosphateANDA 207211	Macleods Pharms	3	Marketed
Sep 14, 2017	Oseltamivir PhosphateANDA 209113	Zydus Pharms	5	Marketed
Oct 31, 2017	Oseltamivir PhosphateANDA 208823	Alvogen	3	Marketed
Jan 9, 2018	Oseltamivir PhosphateANDA 208348	Lupin	3	Marketed
Feb 20, 2018	Oseltamivir PhosphateANDA 208347	Lupin	4	Marketed
Feb 23, 2018	Oseltamivir PhosphateANDA 209438	Hetero Labs Ltd Iii	0	Marketed
Feb 27, 2018	Oseltamivir PhosphateANDA 210186	Amneal Pharms Ny	4	Discontinued
Jun 8, 2018	Oseltamivir PhosphateANDA 209421	Strides Pharma	2	Marketed
Feb 27, 2019	Oseltamivir PhosphateANDA 211125	Teva Pharms USA	0	Marketed
Jun 24, 2019	Oseltamivir PhosphateANDA 211823	Alembic	1	Marketed
Mar 4, 2020	Oseltamivir PhosphateANDA 212739	Sunshine	0	Marketed
May 20, 2020	Oseltamivir PhosphateANDA 212544	Msn	0	Marketed
May 27, 2020	Oseltamivir PhosphateANDA 212784	Ajanta Pharma Ltd	3	Marketed
Jan 21, 2021	Oseltamivir PhosphateANDA 210157	Rising	0	Discontinued
Aug 30, 2021	Oseltamivir PhosphateANDA 212858	Invagen Pharms	0	Marketed
Oct 1, 2021	Oseltamivir PhosphateANDA 215208	Epic Pharma LLC	0	Marketed
Jan 5, 2022	Oseltamivir PhosphateANDA 213594	Sunshine	0	Marketed
Jan 13, 2022	Oseltamivir PhosphateANDA 211894	Strides Pharma	0	Marketed
Feb 28, 2022	Oseltamivir PhosphateANDA 214949	Leading	0	Discontinued
Mar 28, 2022	Oseltamivir PhosphateANDA 209590	Hetero Labs Ltd V	1	Marketed
May 2, 2022	Oseltamivir PhosphateANDA 215313	Msn	0	Marketed
Jul 25, 2022	Oseltamivir PhosphateANDA 214726	Accord Hlthcare	0	Discontinued
Feb 14, 2023	Oseltamivir PhosphateANDA 215538	Epic Pharma LLC	0	Marketed
Oct 3, 2023	Oseltamivir PhosphateANDA 217467	Invagen Pharms	0	Marketed
Nov 24, 2023	Oseltamivir PhosphateANDA 218009	Zhejiang Poly Pharm	1	Marketed
May 1, 2024	Oseltamivir PhosphateANDA 218565	Laurus	0	Marketed
May 10, 2024	Oseltamivir PhosphateANDA 218131	Aurobindo Pharma Ltd	0	Marketed
Jul 2, 2024	Oseltamivir PhosphateANDA 217303	Pharmobedient	0	Marketed
Oct 30, 2024	Oseltamivir PhosphateANDA 217133	Beijing Jialin	0	Marketed
Dec 3, 2024	Oseltamivir PhosphateANDA 217451	Cediprof Inc	0	Discontinued
Mar 3, 2025	Oseltamivir PhosphateANDA 213695	Jubilant Generics	0	Marketed
Jul 9, 2025	Oseltamivir PhosphateANDA 217274	Shandong	0	Marketed
Jan 22, 2026	Oseltamivir PhosphateANDA 213437	Upsher Smith Labs	0	Discontinued
Jun 25, 2026	Oseltamivir PhosphateANDA 218307	Alembic	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA