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, Laurus, 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-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for oseltamivir phosphate

US Patents:	0
Tradenames:	2
Applicants:	24
NDAs:	31
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	25
Patent Applications:	4,801
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in oseltamivir phosphate?	oseltamivir phosphate excipients list
DailyMed Link:	oseltamivir phosphate at DailyMed

Recent Clinical Trials for oseltamivir phosphate

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

Sponsor	Phase
Nanjing Zenshine Pharmaceuticals	Phase 1
Laboratorios Andromaco S.A.	Phase 1
Sunshine Lake Pharma Co., Ltd.	Phase 1

See all oseltamivir phosphate clinical trials

Pharmacology for oseltamivir phosphate

Drug Class	Neuraminidase Inhibitor
Mechanism of Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for oseltamivir phosphate

Antiviral Agents
Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for oseltamivir phosphate

J05AH	Neuraminidase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	FOR SUSPENSION;ORAL	210186-001	Feb 27, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	214726-002	Jul 25, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	202595-002	Aug 3, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	202595-001	Aug 3, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sunshine	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	FOR SUSPENSION;ORAL	213594-001	Jan 5, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-002	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-002	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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