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Last Updated: January 28, 2020

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ZYVOX Drug Profile

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When do Zyvox patents expire, and what generic alternatives are available?

Zyvox is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. There are two patents protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in ZYVOX 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 Zyvox

A generic version of ZYVOX was approved as linezolid by TEVA PHARMS on January 28th, 2020.

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Drug patent expirations by year for ZYVOX
Drug Prices for ZYVOX

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Recent Litigation for ZYVOX

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 ZYVOX litigation

Pharmacology for ZYVOX
Synonyms for ZYVOX
(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
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 (TN)
Zyvox; PNU 100766; U 100766
Zyvoxa
Zyvoxam
Zyvoxid
Paragraph IV (Patent) Challenges for ZYVOX
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 ZYVOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 ZYVOX

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

Supplementary Protection Certificates for ZYVOX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 12/2002 Austria   Start Trial PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
0717738 PA2004004,C0717738 Lithuania   Start Trial 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
0717738 SPC/GB01/025 United Kingdom   Start Trial PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Boehringer Ingelheim
Dow
Johnson and Johnson
Merck

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