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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 Orchid Hlthcare, 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 |
| Bulk Api Vendors: | 66 |
| Patent Applications: | 3,296 |
| What excipients (inactive ingredients) are in GEMIFLOXACIN MESYLATE? | GEMIFLOXACIN MESYLATE excipients list |
| DailyMed Link: | GEMIFLOXACIN MESYLATE at DailyMed |
Paragraph IV (Patent) Challenges for GEMIFLOXACIN MESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FACTIVE | TABLET;ORAL | gemifloxacin mesylate | 021158 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orchid Hlthcare | GEMIFLOXACIN MESYLATE | gemifloxacin mesylate | TABLET;ORAL | 090466-001 | Jun 15, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | Start Trial | Start Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | Start Trial | Start Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | Start Trial | Start Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
