FACTIVE Drug Patent Profile
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Which patents cover Factive, and what generic alternatives are available?
Factive is a drug marketed by Lg Chem Ltd and is included in one NDA.
The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Additional details are available on the gemifloxacin mesylate profile page.
Summary for FACTIVE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 2 |
| Patent Applications: | 207 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in FACTIVE? | FACTIVE excipients list |
| DailyMed Link: | FACTIVE at DailyMed |
Recent Clinical Trials for FACTIVE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Samsung Medical Center | Phase 3 |
| LG Life Sciences | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for FACTIVE
Paragraph IV (Patent) Challenges for FACTIVE
| 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 FACTIVE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 FACTIVE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lg Chem Ltd | FACTIVE | gemifloxacin mesylate | TABLET;ORAL | 021158-001 | Apr 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FACTIVE
See the table below for patents covering FACTIVE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 1179533 | ⤷ Try a Trial | |
| Denmark | 1223935 | ⤷ Try a Trial | |
| Denmark | 0981527 | ⤷ Try a Trial | |
| South Korea | 0131999 | ⤷ Try a Trial | |
| Hungary | 227536 | NAPHTYRIDINE CARBOXYLIC ACID DERIVATIVE SALT | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated 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.
ISSN: 2162-2639
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