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Generated: December 10, 2018

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Linezolid - Generic Drug Details

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

Linezolid is the generic ingredient in three branded drugs marketed by West-ward Pharms Int, Pharmacia And Upjohn, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in twenty-four NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Linezolid has seventy-nine patent family members in thirty-six countries.

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

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-(((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
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
D07UYO
DB00601
DSSTox_CID_26489
DSSTox_GSID_46489
DSSTox_RID_81660
DTXSID5046489
FT-0080803
FT-0602524
GA2609
HE063000
HE316819
HMS2051F08
HMS2089K06
HMS3260C14
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 sodium chloride
Linezolid, >=98% (HPLC)
Linezolid, Pharmaceutical Secondary Standard; Certified Reference Material
Linezolid, United States Pharmacopeia (USP) Reference Standard
Linezolid|165800-03-3|Zyvoxid
LINEZOLIDE
Linezolidum
linospan
linox
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
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
PNU-100766, U-100766, Zyvoxid, Zyvoxam, Linezolid
Q-201308
QCR-88
s1408
SAM001246624
SC-11638
SCHEMBL5027
SMR000466335
ST2408359
SYN3021
TL8001272
Tox21_112246
Tox21_500096
TYZROVQLWOKYKF-ZDUSSCGKSA-N
U 100766
U-100,766
U-100766
UNII-ISQ9I6J12J
ZINC2008866
Zivoxid
ZLD
Zyvox
Zyvox (TN)
Zyvoxa
Zyvoxam
Zyvoxam (TN)
Zyvoxid
Zyvoxid (TN)

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
Sandoz Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 200904-002 Jul 16, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alembic Pharms Ltd LINEZOLID linezolid TABLET;ORAL 205233-001 Dec 21, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd LINEZOLID linezolid SOLUTION;INTRAVENOUS 205154-001 Dec 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hq Spclt Pharma LINEZOLID linezolid SOLUTION;INTRAVENOUS 207001-002 Jul 7, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for linezolid

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

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Supplementary Protection Certificates for linezolid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005 France ➤ Sign Up PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
2004004,C0717738 Lithuania ➤ Sign Up PRODUCT NAME: LINEZOLIDUM ((S)-N-((3-(3-FLUOR-4-(4-MORFOLINIL)FENIL)-2-OKSO--5-OKSAZOLIDINIL)METIL)-ACETAMIDAS); REGISTRATION NO/DATE: 02/8199/2 20030313
/2002 Austria ➤ Sign Up PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
C/GB01/025 United Kingdom ➤ Sign Up PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
2004004 Lithuania ➤ Sign Up PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Accenture
Daiichi Sankyo
Express Scripts
Dow
Johnson and Johnson
Julphar
Deloitte

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