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TAMIFLU

NDA

OSELTAMIVIR PHOSPHATE | N021246 | HOFFMANN LA ROCHE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

47 trials from ClinicalTrials.gov — 1 recruiting, 27 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients NCT00867139	Phase 1/2	Completed	Fred Hutchinson Cancer Center	7	2009-03 → 2010-01
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza NCT02369159	Phase 3	Completed	BioCryst Pharmaceuticals	137	2015-03-11 → 2020-05-14
Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults NCT00921726	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	17	2009-07 → 2009-10
Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions NCT02941731	Phase 1	Completed	Hanmi Pharmaceutical Company Limited	32	2015-04 → 2015-09
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers NCT01172847	Phase 1	Completed	Hoffmann-La Roche	24	2009-08 → 2010-02
Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.NCT00304434	Phase 4	Completed	US Department of Veterans Affairs	48	2005-02 → 2007-02
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza NCT02954354	Phase 3	Completed	Shionogi	1,436	2016-12-08 → 2017-04-24
ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir NCT02609399	Phase 4	Completed	Johns Hopkins University	180	2015-11-01 → 2018-05-31
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms NCT03629184	Phase 3	Completed	Hoffmann-La Roche	173	2018-11-20 → 2019-04-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.43

per ml

Lowest NADAC/Unit

$2.43

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00004082205TAMIFLU 6 MG/ML SUSPENSION	$2.43	ML	Brand	$0.1567	2026-02-18

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$118.98

Highest Price

$149.59

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00004-0822-05TAMIFLU 6MG/ML SUSPENSION,ORAL	$149.59	FSS	Genentech USA, Inc.	09/14/2028
00004-0822-05TAMIFLU 6MG/ML SUSPENSION,ORAL	$118.98	Big4	Genentech USA, Inc.	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain23 active DMFs

23 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDOSELTAMIVIR PHOSPHATE USP

DMF 215572008

SOLARA ACTIVE PHARMA SCIENCES LTDOSELTAMIVIR PHOSPHATE

DMF 229262009

MSN PHARMACHEM PRIVATE LTDOSELTAMIVIR PHOSPHATE [ROUTE CODE - "OT"]

DMF 238892010

MACLEODS PHARMACEUTICALS LTDOSELTAMIVIR PHOSPHATE

DMF 275332013

MATRIX PHARMACORP PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 300122015

LUPIN LTDOSELTAMIVIR PHOSPHATE USP

DMF 302532016

HETERO LABS LTDOSELTAMIVIR PHOSPHATE

DMF 304122016

RAKS PHARMA PVT LTDOSELTAMIVIR PHOSPHATE USP

DMF 333732018

LAURUS LABS LTDOSELTAMIVIR PHOSPHATE USP

DMF 337672020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 339072020

INNOVARE LABS PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 347752020

AMPAC FINE CHEMICALS LLCOSELTAMIVIR PHOSPHATE DRUG SUBSTANCE

DMF 352342021

MSN LIFE SCIENCES PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 354092020

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 355142021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDOSELTAMIVIR PHOSPHATE

DMF 358762021

AZICO BIOPHORE INDIA PRIVATE LTDOSELTAMIVIR PHOSPHATE

DMF 361832021

CHROMO LABORATORIES INDIA PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 369712022

ZYDUS LIFESCIENCES LTDOSELTAMIVIR PHOSPHATE USP

DMF 376772022

RUYUAN HEC PHARM CO LTDOSELTAMIVIR PHOSPHATE NON-STERILE BULK DRUG SUBSTANCE

DMF 387162023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE USP

DMF 393142023

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 406032024

FUJIAN FUKANG PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 421352025

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)OSELTAMIVIR PHOSPHATE USP

DMF 432362025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

41 letters from Drugs@FDA

Date	Submission	Document
Aug 11, 2021	SUPPL -55	View Letter (PDF)
Aug 5, 2019	SUPPL -54	View Letter (PDF)
Dec 19, 2018	SUPPL -53	View Letter (PDF)
Apr 6, 2018	SUPPL -52	View Letter (PDF)
Jun 22, 2016	SUPPL -51	View Letter (PDF)
Nov 28, 2014	SUPPL -43	View Letter (PDF)
Oct 16, 2014	SUPPL -48	View Letter (PDF)
Jun 3, 2014	SUPPL -47	View Letter (PDF)
Jan 29, 2013	SUPPL -44	View Letter (PDF)
Dec 21, 2012	SUPPL -45	View Letter (PDF)
Aug 20, 2012	SUPPL -42	View Letter (PDF)
Mar 24, 2011	SUPPL -39	View Letter (PDF)
Feb 9, 2011	SUPPL -40	View Letter (PDF)
Dec 21, 2010	SUPPL -31	View Letter (PDF)
Nov 10, 2010	SUPPL -38	View Letter (PDF)
Feb 26, 2010	SUPPL -35	View Letter (PDF)
Feb 26, 2010	SUPPL -34	View Letter (PDF)
Oct 21, 2009	SUPPL -26	View Letter (PDF)
Oct 21, 2009	SUPPL -25	View Letter (PDF)
Oct 21, 2009	SUPPL -22	View Letter (PDF)
Oct 21, 2009	SUPPL -24	View Letter (PDF)
Oct 19, 2009	SUPPL -11	View Letter (PDF)
Oct 19, 2009	SUPPL -32	View Letter (PDF)
Oct 19, 2009	SUPPL -23	View Letter (PDF)
Oct 19, 2009	SUPPL -13	View Letter (PDF)
Oct 19, 2009	SUPPL -14	View Letter (PDF)
Oct 19, 2009	SUPPL -19	View Letter (PDF)
Oct 19, 2009	SUPPL -20	View Letter (PDF)
Oct 19, 2009	SUPPL -18	View Letter (PDF)
Oct 19, 2009	SUPPL -16	View Letter (PDF)
Oct 19, 2009	SUPPL -12	View Letter (PDF)
Oct 16, 2009	SUPPL -8	View Letter (PDF)
Apr 30, 2009	SUPPL -33	View Letter (PDF)
Jan 18, 2008	SUPPL -30	View Letter (PDF)
Oct 10, 2007	SUPPL -28	View Letter (PDF)
Jul 5, 2007	SUPPL -27	View Letter (PDF)
Nov 16, 2006	SUPPL -21	View Letter (PDF)
Jan 18, 2006	SUPPL -17	View Letter (PDF)
Jul 1, 2004	SUPPL -10	View Letter (PDF)
Apr 26, 2002	SUPPL -7	View Letter (PDF)
Dec 14, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 12MG BASE/ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 14, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 6MG BASE/ML

RLDAB

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Mar 21, 2011