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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
Cantor Fitzgerald
Johnson and Johnson
Harvard Business School
Moodys
Colorcon
QuintilesIMS
Healthtrust

Generated: April 19, 2018

DrugPatentWatch Database Preview

Levofloxacin - Generic Drug Details

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What are the generic sources for levofloxacin and what is the scope of levofloxacin patent protection?

Levofloxacin
is the generic ingredient in six branded drugs marketed by Janssen Pharms, Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, Apotex Inc, Mylan Labs Ltd, Rising Pharms Inc, Watson Labs Teva, Hi Tech Pharma, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, and Wockhardt, and is included in forty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levofloxacin has seven patent family members in seven countries.

There are thirty drug master file entries for levofloxacin. Sixty-seven suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for levofloxacin
Pharmacology for levofloxacin
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MG/MLINJECTABLE; INJECTION
➤ Try a Free Trial➤ Try a Free Trial250MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial750MGTABLET; ORAL

US Patents and Regulatory Information for levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328-001 Jan 24, 2013 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 078282-001 Dec 20, 2010 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801-003 Jan 8, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Rising Pharms Inc LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 077700-001 Dec 20, 2010 AT RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for levofloxacin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB97/085 United Kingdom ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
80016 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
C0041 Belgium ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Cerilliant
Baxter
Merck
Farmers Insurance
McKesson
Julphar
Teva

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.