GEMIFLOXACIN MESYLATE - Generic Drug Details
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What are the generic drug sources for gemifloxacin mesylate and what is the scope of freedom to operate?
Gemifloxacin mesylate
is the generic ingredient in two branded drugs marketed by Lg Chem Ltd and Orbion Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for gemifloxacin mesylate.
Summary for GEMIFLOXACIN MESYLATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Patent Applications: | 3,907 |
What excipients (inactive ingredients) are in GEMIFLOXACIN MESYLATE? | GEMIFLOXACIN MESYLATE excipients list |
DailyMed Link: | GEMIFLOXACIN MESYLATE at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for GEMIFLOXACIN MESYLATE
Paragraph IV (Patent) Challenges for GEMIFLOXACIN MESYLATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FACTIVE | Tablets | gemifloxacin mesylate | 320 mg | 021158 | 1 | 2008-03-04 |
US Patents and Regulatory Information for GEMIFLOXACIN MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Orbion Pharms | GEMIFLOXACIN MESYLATE | gemifloxacin mesylate | TABLET;ORAL | 090466-001 | Jun 15, 2015 | 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 |
Expired US Patents for GEMIFLOXACIN MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |