LEVAQUIN Drug Patent Profile

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When do Levaquin patents expire, and what generic alternatives are available?

Levaquin is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in LEVAQUIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levaquin

A generic version of LEVAQUIN was approved as levofloxacin by RISING on December 20^th, 2010.

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Summary for LEVAQUIN

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	24
Patent Applications:	5,337
Drug Prices:	Drug price information for LEVAQUIN
What excipients (inactive ingredients) are in LEVAQUIN?	LEVAQUIN excipients list
DailyMed Link:	LEVAQUIN at DailyMed

Drug patent expirations by year for LEVAQUIN

Recent Clinical Trials for LEVAQUIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indonesia University	Phase 1/Phase 2
Harvard Medical School	Phase 2
University of California, San Francisco	Phase 2

See all LEVAQUIN clinical trials

Paragraph IV (Patent) Challenges for LEVAQUIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEVAQUIN	Oral Solution	levofloxacin	25 mg/mL	021721	1	2009-07-30

US Patents and Regulatory Information for LEVAQUIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996		DISCN	Yes	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
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004		DISCN	Yes	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

Expired US Patents for LEVAQUIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-003	Sep 8, 2000	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-002	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	TABLET;ORAL	020634-002	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

EU/EMA Drug Approvals for LEVAQUIN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789 Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for LEVAQUIN

See the table below for patents covering LEVAQUIN around the world.

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Country	Patent Number	Title	Estimated Expiration
Yugoslavia	42422		⤷ Sign Up
Ireland	861631		⤷ Sign Up
Spain	556292		⤷ Sign Up
India	155680	A PROCESS FOR PREPARING A 9-HALO-7-OXO-2,3-DIHYDRO-7H-PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE-6-CARBOXYLIC ACID COMPOUND	⤷ Sign Up
Austria	85057		⤷ Sign Up
Norway	169896		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LEVAQUIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	SPC/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
0206283	98C0041	Belgium	⤷ Sign Up	PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283	C980016	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for LEVAQUIN

Recent Clinical Trials for LEVAQUIN

Paragraph IV (Patent) Challenges for LEVAQUIN

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