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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Chinese Patent Office
Boehringer Ingelheim
Deloitte
Accenture
McKinsey
Citi
Teva
McKesson

Generated: January 19, 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, 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-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.

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

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
Gate Pharms LINEZOLID linezolid TABLET;ORAL 091210-001 Feb 5, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novel Labs Inc LINEZOLID linezolid TABLET;ORAL 207526-001 Aug 22, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz Inc LINEZOLID linezolid SOLUTION;IV (INFUSION) 200904-002 Jul 16, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa LINEZOLID linezolid SOLUTION;IV (INFUSION) 204764-001 Mar 15, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hq Spclt Pharma LINEZOLID linezolid SOLUTION;IV (INFUSION) 207001-001 Jul 7, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Teva Pharms LINEZOLID linezolid SOLUTION;IV (INFUSION) 200222-001 Jun 27, 2012 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc LINEZOLID linezolid TABLET;ORAL 206097-001 Feb 22, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 021130-002 Apr 18, 2000 ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid SOLUTION;IV (INFUSION) 021131-001 Apr 18, 2000 ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for linezolid

Supplementary Protection Certificates for linezolid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005 France ➤ Subscribe PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
C/GB01/025 United Kingdom ➤ Subscribe PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
/2002 Austria ➤ Subscribe PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
2004004 Lithuania ➤ Subscribe PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
2004004,C0717738 Lithuania ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Cipla
Covington
Fuji
Julphar
Medtronic
Queensland Health
Boehringer Ingelheim

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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