GATIFLOXACIN - Generic Drug Details

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

Gatifloxacin is the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, Torrent, Allergan, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for gatifloxacin. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for GATIFLOXACIN

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	33
Patent Applications:	7,110
Drug Prices:	Drug price trends for GATIFLOXACIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GATIFLOXACIN
What excipients (inactive ingredients) are in GATIFLOXACIN?	GATIFLOXACIN excipients list
DailyMed Link:	GATIFLOXACIN at DailyMed

See drug prices for GATIFLOXACIN

Drug Sales Revenue Trends for GATIFLOXACIN

See drug sales revenues for GATIFLOXACIN

Recent Clinical Trials for GATIFLOXACIN

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

Sponsor	Phase
Shaheed Benazir Bhutto University Sheringal Dir Upper	Phase 1
Khyber Medical University Peshawar	Phase 1
Laboratorios Sophia S.A de C.V.	Phase 3

See all GATIFLOXACIN clinical trials

Generic filers with tentative approvals for GATIFLOXACIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.3%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for GATIFLOXACIN

Drug Class	Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for GATIFLOXACIN

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for GATIFLOXACIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYMAXID	Ophthalmic Solution	gatifloxacin	0.5 %	022548	1	2010-12-07
ZYMAR	Ophthalmic Solution	gatifloxacin	0.3 %	021493	1	2007-07-19

US Patents and Regulatory Information for GATIFLOXACIN

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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
Torrent	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	213542-001	Nov 3, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	203189-001	Sep 3, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	202653-001	Aug 28, 2013	AT	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

Expired US Patents for GATIFLOXACIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003	⤷ Sign Up	⤷ Sign Up
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	⤷ Sign Up	⤷ Sign Up
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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