GATIFLOXACIN - Generic Drug Details
✉ Email this page to a colleague
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: | 7,105 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for GATIFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Khyber Medical University Peshawar | Phase 1 |
Shaheed Benazir Bhutto University Sheringal Dir Upper | Phase 1 |
Laboratorios Sophia S.A de C.V. | Phase 3 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 204227-001 | Jul 11, 2016 | AT | RX | 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 | |||
Allergan | ZYMAR | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 021493-001 | Mar 28, 2003 | 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 GATIFLOXACIN
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 |
Allergan | ZYMAR | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 021493-001 | Mar 28, 2003 | ⤷ Sign Up | ⤷ Sign Up |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.