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Generated: April 20, 2018

DrugPatentWatch Database Preview

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
Nang Kuang Pharm Co LINEZOLID linezolid SOLUTION;IV (INFUSION) 207354-002 Dec 20, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc LINEZOLID linezolid TABLET;ORAL 206097-001 Feb 22, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms LINEZOLID linezolid TABLET;ORAL 204536-001 Dec 21, 2015 AB 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
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 TABLET;ORAL 021130-001 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 FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn ZYVOX linezolid SOLUTION;IV (INFUSION) 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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Non-Orange Book US Patents for linezolid

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,444,813 Linezolid-crystal form II ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for linezolid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
2004004 Lithuania ➤ Sign Up PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
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
C0005 France ➤ Sign Up PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Daiichi Sankyo
Teva
Julphar
Boehringer Ingelheim
Covington
Johnson and Johnson
Moodys

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.