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Generated: September 23, 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 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, 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-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 Up750MGTABLET; ORAL
➤ Sign Up➤ Sign Up500MGTABLET; 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 IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919-003 Feb 10, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361-002 Jun 20, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics LEVOFLOXACIN levofloxacin TABLET;ORAL 200250-002 Jun 20, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652-003 Sep 7, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919-002 Feb 10, 2016 AP 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
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375-003 Sep 16, 2011 AP 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

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Expired US Patents for LEVOFLOXACIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996 ➤ Sign Up ➤ Sign Up
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 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 IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-003 Sep 8, 2000 ➤ Sign Up ➤ Sign Up
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
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

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Moodys
US Army
Covington
Argus Health
Harvard Business School
Mallinckrodt
Healthtrust
Chinese Patent Office

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