ZYVOX Drug Patent Profile

Which patents cover Zyvox, and what generic alternatives are available?

Zyvox is a drug marketed by Pfizer and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyvox

A generic version of ZYVOX was approved as linezolid by HIKMA on June 3^rd, 2015.

Summary for ZYVOX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	121
Patent Applications:	5,041
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZYVOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYVOX
What excipients (inactive ingredients) are in ZYVOX?	ZYVOX excipients list
DailyMed Link:	ZYVOX at DailyMed

See drug prices for ZYVOX

Pharmacology for ZYVOX

Drug Class

Oxazolidinone Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for ZYVOX

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ZYVOX

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 ZYVOX

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

Expired US Patents for ZYVOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	FOR SUSPENSION;ORAL	021132-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-003	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000

International Patents for ZYVOX

See the table below for patents covering ZYVOX around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I293028
New Zealand	271805	OXAZINE AND THIAZINE OXAZOLIDINONE DERIVATIVES AND ANTIMICROBIAL COMPOSITIONS THEREOF
South Korea	100864745
Hong Kong	1054325	噁唑烷酮片劑的配方 (OXAZOLIDINONE TABLET FORMULATION)
Denmark	1265608
Canada	2395603	FACIES DE CRISTAUX DE LINEZOLIDE (FORME II) (LINEZOLID-CRYSTAL FORM II)
China	1130379

Supplementary Protection Certificates for ZYVOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0717738	02C0005	France		PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0717738	SPC001/2002	Ireland		SPC001/2002: 20031204, EXPIRES: 20160104
0717738	CA 2002 00004	Denmark
0717738	PA2004004,C0717738	Lithuania		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	PA2004004	Lithuania		PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
0717738	SPC/GB01/025	United Kingdom		PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
0717738	12/2002	Austria		PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105