Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Mallinckrodt
Colorcon
Harvard Business School
AstraZeneca

Last Updated: February 19, 2020

DrugPatentWatch Database Preview

LINEZOLID Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

When do Linezolid patents expire, and when can generic versions of Linezolid launch?

Linezolid is a drug marketed by Hikma, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Celltrion, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms. and is included in twenty-two NDAs.

The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the linezolid profile page.

US ANDA Litigation and Generic Entry Outlook for Linezolid

A generic version of LINEZOLID was approved as linezolid by TEVA PHARMS on June 27th, 2012.

  Start Trial

Drug patent expirations by year for LINEZOLID
Drug Prices for LINEZOLID

See drug prices for LINEZOLID

Recent Clinical Trials for LINEZOLID

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

SponsorPhase
European UnionPhase 3
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 3
European and Developing Countries Clinical Trials Partnership (EDCTP)Phase 3

See all LINEZOLID clinical trials

Recent Litigation for LINEZOLID

Identify potential future generic entrants

District Court Litigation
Case NameDate
SYMED LABS LIMITED v. ROXANE LABORATORIES, INC.2015-11-25
Pharmacia & Upjohn Company LLC v. Apotex, Inc.2013-03-15

See all LINEZOLID litigation

Pharmacology for LINEZOLID
Medical Subject Heading (MeSH) Categories for LINEZOLID
Synonyms for LINEZOLID
(Linezolid)N-[3-(3-Fluoro-4-morpholin-4-yl-phenyl)-2-oxo-oxazolidin-5-ylmethyl]-acetamide
(R)-N-((3-(3-fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide
(S)-3-(3-Fluoro-4-morpholin-4-yl-phenyl)-5-[(1-hydroxy-ethylamino)-methyl]-oxazolidin-2-one
(S)-N-((3-(3-fluoro-4-(4-morpholinyl)phenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide
(S)-N-((3-(3-fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide
(S)-N-((3-fluoro-4-morpholinophenyl)-2-oxaoxazolidin-5-yl)methyl)acetamide
(S)-N-[ [3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-oxazolidin-5-yl]methyl]-acetamide
(S)-N-[[3-(3-Fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl]methyl]acetamide
(S)-N-[[3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-oxazolidinyl]methyl]acetamide
(S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide
111GE017
165800-03-3
800L033
A810662
AB0012049
AB00639994_10
AB00639994_11
AB00639994-06
AB00639994-08
AB00639994-09
AC1L9B3M
Acetamide, N-(((5S)-3-(3-fluoro-4-(4-morpholinyl)phenyl)-2-oxo-5-oxazolidinyl)methyl)-
Acetamide, N-((3-(3-fluoro-4-(4-morpholinyl)phenyl)-2-oxo-5-oxazolidinyl)methyl)-, (S)-
Acetamide, N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-
AJ-32488
AK105905
AKOS016340522
AM84567
AN-15409
AX8042607
BCP05586
BCP9000855
BDBM50116067
Benzotriazol-2-yl-acetonitrile
BIDD:GT0404
C-20237
C08146
C16H20FN3O4
CAS-165800-03-3
CC-29960
CCG-101009
CHEBI:63607
CHEMBL126
cid_441401
CJ-07345
CPD000466335
CS-0756
D00947
DB00601
DSSTox_CID_26489
DSSTox_GSID_46489
DSSTox_RID_81660
DTXSID5046489
FT-0080803
FT-0602524
GA2609
HMS2051F08
HMS2089K06
HMS3260C14
HMS3713K10
HSDB 7478
HY-10394
ISQ9I6J12J
J90009
KS-00000BB5
KS-1178
Linezlid
Linezoid
Linezolid (JAN/USAN/INN)
Linezolid (PNU-100766)
Linezolid (Zyvox)
Linezolid [USAN:INN:BAN]
Linezolid [USAN:INN]
Linezolid & VRC3375
Linezolid, >=98% (HPLC)
Linezolid, 98%
Linezolid, Pharmaceutical Secondary Standard; Certified Reference Material
Linezolid, United States Pharmacopeia (USP) Reference Standard
Linezolid|165800-03-3|Zyvoxid
LINEZOLIDE
Linezolidum
LS-173594
M-8338
MFCD00937825
MLS000759444
MLS001424075
MolPort-003-986-503
N-(((5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl)methyl)-acetamide
N-(((S)-3-(3-Fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide
N-((3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide
N-((S)-2-oxo-3-(S)-2,3,3a,4-tetrahydro-1H-benzo[b]pyrrolo[1,2-d][1,4]oxazin-7-yl-oxazolidin-5-ylmethyl)-acetamide
N-({(5S)-3-[3-fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide
N-({5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide, N-[[(S)-3-(3-Fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl]methyl]acetamide
N-[(R)-3-(3-Fluoro-4-morpholin-4-yl-phenyl)-2-oxo-oxazolidin-5-ylmethyl]-acetamide
N-[(S)-3-(3-Fluoro-4-morpholin-4-yl-phenyl)-2-oxo-oxazolidin-5-ylmethyl]-acetamide
N-[[(5S)-3-(3-fluoranyl-4-morpholin-4-yl-phenyl)-2-oxidanylidene-1,3-oxazolidin-5-yl]methyl]ethanamide
N-[[(5S)-3-(3-fluoro-4-morpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl]acetamide
N-[[(5S)-3-(3-fluoro-4-morpholino-phenyl)-2-oxo-oxazolidin-5-yl]methyl]acetamide
N-[[(5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide
N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide
N-[3-(3-Fluoro-4-morpholin-4-yl-phenyl)-2-oxo-oxazolidin-5-ylmethyl]-acetamide
N-[3-(3-Fluoro-4-morpholin-4-yl-phenyl)-2-oxo-oxazolidin-5-ylmethyl]-acetamide(linezolid)
N-{[(5s)-3-(3-Fluoro-4-Morpholin-4-Ylphenyl)-2-Oxo-1,3-Oxazolidin-5-Yl]methyl}acetamide
N-{[(5S)-3-[3-fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl}acetamide
NC00259
NCGC00164628-01
NCGC00260781-01
NCGC00263531-03
NCGC00263531-10
NDA 21-130 Zyvox (linezolid tablets)
NDA 21-131 Zyvox for injection (linezolid injection)
NDA 21-132 Zyvox oral suspension (linzolid oral suspension)
PNU 100766
PNU-100766
Q-201308
QCR-88
s1408
SAM001246624
SC-11638
SCHEMBL5027
SMR000466335
SR-01000759376
SR-01000759376-4
SR-01000759376-5
ST2408359
SW197639-3
SYN3021
TL8001272
Tox21_112246
Tox21_500096
TYZROVQLWOKYKF-ZDUSSCGKSA-N
U 100766
U-100,766
U-100766
UNII-ISQ9I6J12J
ZINC2008866
Zivoxid
ZLD
Zyvox
Zyvox (TN)
Zyvox; PNU 100766; U 100766
Zyvoxa
Zyvoxam
Zyvoxid
Paragraph IV (Patent) Challenges for LINEZOLID
Tradename Dosage Ingredient NDA Submissiondate
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-12-29
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-09-01
ZYVOX FOR SUSPENSION;ORAL linezolid 021132 2009-08-03
ZYVOX TABLET;ORAL linezolid 021130 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   Start Trial   Start Trial   Start Trial
Amneal Pharms LINEZOLID linezolid TABLET;ORAL 204536-001 Dec 21, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc LINEZOLID linezolid TABLET;ORAL 207526-001 Aug 22, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd LINEZOLID linezolid SOLUTION;INTRAVENOUS 205154-001 Dec 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 205442-001 Jul 7, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 204696-002 Mar 2, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Gate Pharms LINEZOLID linezolid TABLET;ORAL 091210-001 Feb 5, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Mallinckrodt
Johnson and Johnson
Harvard Business School
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.