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Linezolid - Generic Drug Details

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Linezolid is the generic ingredient in three branded drugs marketed by Sandoz Inc, Gate Pharms, Aurobindo Pharma Ltd, Alkem Labs Ltd, Teva Pharms, Novel Labs Inc, Pharmacia And Upjohn, Alembic Pharms Ltd, Amneal Pharms, Hetero Labs Ltd V, Hospira Inc, Mylan Pharms Inc, Teva Pharms Usa, Fresenius Kabi Usa, Roxane, and Glenmark Pharms, and is included in nineteen NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-two patent family members in thirty-six countries.

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

Summary for Generic Name: linezolid

Tradenames:3
Patents:2
Applicants:16
NDAs:19
Drug Master File Entries: see list22
Suppliers / Packaging: see list27
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: linezolid

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms
LINEZOLID
linezolid
TABLET;ORAL078987-001Dec 21, 2015RXNo► subscribe► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 2000RXYes6,559,305*PED► subscribeY► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
SOLUTION;IV (INFUSION)021131-002Apr 18, 2000RXNo6,559,305*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: linezolid

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
FOR SUSPENSION;ORAL021132-001Apr 18, 20005,688,792*PED► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 20005,688,792*PED► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 20005,688,792*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: linezolid

Country Document Number Estimated Expiration
Czech Republic302292► subscribe
MexicoPA02009316► subscribe
Portugal1265608► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LINEZOLID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/025United Kingdom► subscribePRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
2004004,C0717738Lithuania► subscribePRODUCT NAME: LINEZOLIDUM ((S)-N-((3-(3-FLUOR-4-(4-MORFOLINIL)FENIL)-2-OKSO--5-OKSAZOLIDINIL)METIL)-ACETAMIDAS); REGISTRATION NO/DATE: 02/8199/2 20030313
/2002Austria► subscribePRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
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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.

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