GATIFLOXACIN Drug Patent Profile
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When do Gatifloxacin patents expire, and when can generic versions of Gatifloxacin launch?
Gatifloxacin is a drug marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, and Torrent. and is included in six NDAs.
The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gatifloxacin
A generic version of GATIFLOXACIN was approved as gatifloxacin by LUPIN LTD on August 28th, 2013.
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Questions you can ask:
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Summary for GATIFLOXACIN
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 140 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,447 |
| Drug Prices: | Drug price information 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
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 |
Pharmacology for GATIFLOXACIN
| Drug Class | Quinolone Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for GATIFLOXACIN
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Inc | GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 079084-001 | Aug 19, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 206446-001 | Jun 8, 2018 | DISCN | No | No | ⤷ 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 | |||
| Torrent | GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 213542-001 | Nov 3, 2021 | DISCN | 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 |
