Linezolid - Generic Drug Details

What are the generic drug sources for linezolid and what is the scope of patent protection?

Linezolid is the generic ingredient in three branded drugs marketed by Hetero Labs, Hikma, Pfizer, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for linezolid. Twenty-four suppliers are listed for this compound.

Summary for linezolid

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	27
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	144
Patent Applications:	6,472
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for linezolid
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linezolid
What excipients (inactive ingredients) are in linezolid?	linezolid excipients list
DailyMed Link:	linezolid at DailyMed

See drug prices for linezolid

Recent Clinical Trials for linezolid

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

Sponsor	Phase
Beijing Chest Hospital	Phase 3
National Medical Center for Infectious Diseases	Phase 3
Assistance Publique Hopitaux De Marseille	Phase 4

See all linezolid clinical trials

Pharmacology for linezolid

Drug Class

Oxazolidinone Antibacterial

Medical Subject Heading (MeSH) Categories for linezolid

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for linezolid

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for LINEZOLID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYVOX	Injection	linezolid	2 mg/mL, 100 mL bag	021131	1	2009-12-29
ZYVOX	Injection	linezolid	2 mg/mL, 300 mL bag	021131	1	2009-09-01
ZYVOX	Oral Suspension	linezolid	100 mg/5 mL	021132	1	2009-08-03
ZYVOX	Tablets	linezolid	600 mg	021130	1	2005-12-21

US Patents and Regulatory Information for linezolid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	LINEZOLID	linezolid	FOR SUSPENSION;ORAL	200068-001	Jun 3, 2015	AB	RX	No	No
Zydus Pharms	LINEZOLID	linezolid	TABLET;ORAL	206097-001	Feb 22, 2017	AB	RX	No	No
Teva Pharms Usa	LINEZOLID	linezolid	TABLET;ORAL	078061-001	May 18, 2015		DISCN	No	No
Mylan Labs Ltd	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	205154-002	Dec 6, 2017	AP	RX	No	No
Teva Pharms	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	200222-001	Jun 27, 2012		DISCN	No	No
Hospira	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	205442-001	Jul 7, 2015		DISCN	No	No
Fresenius Kabi Usa	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	204764-001	Mar 15, 2016	AP	RX	No	No

Expired US Patents for linezolid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-003	Apr 18, 2000
Pfizer	ZYVOX	linezolid	FOR SUSPENSION;ORAL	021132-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-001	Apr 18, 2000