Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Harvard Business School
Boehringer Ingelheim
Chubb
McKesson
Dow
AstraZeneca
Farmers Insurance
Fish and Richardson

Generated: August 18, 2018

DrugPatentWatch Database Preview

Levofloxacin - Generic Drug Details

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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, Lannett Co Inc, 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-three 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-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for levofloxacin
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up5MG/MLINJECTABLE; INJECTION
➤ Sign Up➤ Sign Up250MGTABLET; ORAL
➤ Sign Up➤ Sign Up750MGTABLET; 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
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438-002 Jun 20, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375-002 Sep 16, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890-002 Mar 30, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361-003 Jun 20, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Expired US Patents for levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-003 Sep 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin SOLUTION;ORAL 021721-001 Oct 21, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for levofloxacin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
80016 Netherlands ➤ Sign Up 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
C/GB97/085 United Kingdom ➤ Sign Up PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
C0041 Belgium ➤ Sign Up 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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Citi
Daiichi Sankyo
Harvard Business School
Queensland Health
Covington
Argus Health
Healthtrust
Moodys

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.