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Serving leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Argus Health
Federal Trade Commission
Accenture
Cantor Fitzgerald
Medtronic
UBS
Harvard Business School
Mallinckrodt

Generated: November 18, 2017

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 Hq Spclt Pharma, 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, Nang Kuang Pharm Co, Teva Pharms Usa, Fresenius Kabi Usa, West-ward Pharms Int, Glenmark Pharms, Sagent Pharms, and Zydus Pharms Usa Inc, and is included in twenty-three 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 and five supplementary protection certificates in four countries.

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

Pharmacology for linezolid

Medical Subject Heading (MeSH) Categories for linezolid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd
LINEZOLID
linezolid
TABLET;ORAL205233-001Dec 21, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
LINEZOLID
linezolid
TABLET;ORAL078845-001Dec 21, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
FOR SUSPENSION;ORAL021132-001Apr 18, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Teva Pharms Usa
LINEZOLID
linezolid
TABLET;ORAL078061-001May 18, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
LINEZOLID
linezolid
FOR SUSPENSION;ORAL200068-001Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Hq Spclt Pharma
LINEZOLID
linezolid
SOLUTION;IV (INFUSION)207001-002Jul 7, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
LINEZOLID
linezolid
SOLUTION;IV (INFUSION)206917-001Aug 4, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
LINEZOLID
linezolid
SOLUTION;IV (INFUSION)200904-001Jul 16, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Nang Kuang Pharm Co
LINEZOLID
linezolid
SOLUTION;IV (INFUSION)207354-001Dec 20, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Alkem Labs Ltd
LINEZOLID
linezolid
TABLET;ORAL205517-001Dec 21, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: linezolid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 2000► Subscribe► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
FOR SUSPENSION;ORAL021132-001Apr 18, 2000► Subscribe► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 2000► Subscribe► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
SOLUTION;IV (INFUSION)021131-001Apr 18, 2000► Subscribe► 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
Spain2312422► Subscribe
South Korea100864745► Subscribe
Poland356433► Subscribe
Yugoslavia69802► Subscribe
South Korea20070094673► Subscribe
Malaysia136370► Subscribe
Austria412413► Subscribe
Brazil0108846► Subscribe
Norway20065836► Subscribe
World Intellectual Property Organization (WIPO)0170225► 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
C0005France► SubscribePRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
/2002Austria► SubscribePRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
2004004Lithuania► SubscribePRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
Chinese Patent Office
Moodys
Healthtrust
Colorcon
Merck
Argus Health
Cantor Fitzgerald
Queensland Health

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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