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Generated: October 16, 2018

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Levofloxacin - Generic Drug Details

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What are the generic drug sources for levofloxacin and what is the scope of levofloxacin freedom to operate?

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, 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.

There are thirty drug master file entries for levofloxacin. Sixty-eight 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
➤ Try a Free Trial➤ Try a Free Trial5MG/MLINJECTABLE; INJECTION
➤ Try a Free Trial➤ Try a Free Trial750MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial500MGTABLET; 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
Glenmark Generics LEVOFLOXACIN levofloxacin TABLET;ORAL 200250-002 Jun 20, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin LEVOFLOXACIN levofloxacin TABLET;ORAL 078424-001 Jun 20, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 201484-001 Nov 22, 2013 DISCN No No ➤ 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 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 levofloxacin TABLET;ORAL 020634-001 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
C0041 Belgium ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
Daiichi Sankyo
Fish and Richardson
Covington
AstraZeneca
US Department of Justice
Federal Trade Commission
Accenture

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