Linezolid - Generic Drug Details

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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 Speclt, 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:	146
Patent Applications:	6,600
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
Institut de Recherche Pour le Developpment	Phase 2
KNCV Tuberculosis Foundation	Phase 2
Tuberculosis Network European Trialsgroup	Phase 2

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

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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
Mylan Labs Ltd	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	205154-002	Dec 6, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	LINEZOLID	linezolid	TABLET;ORAL	204239-001	Dec 21, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Speclt	LINEZOLID	linezolid	TABLET;ORAL	078987-001	Dec 21, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gate Pharms	LINEZOLID	linezolid	TABLET;ORAL	091210-001	Feb 5, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	200904-002	Jul 16, 2015	AP	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 linezolid

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

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