FINAFLOXACIN - Generic Drug Details
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What are the generic sources for finafloxacin and what is the scope of freedom to operate?
Finafloxacin
is the generic ingredient in one branded drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Finafloxacin has forty-two patent family members in eighteen countries.
Summary for FINAFLOXACIN
| International Patents: | 42 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 7 |
| Patent Applications: | 178 |
| DailyMed Link: | FINAFLOXACIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FINAFLOXACIN
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for FINAFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MerLion Pharmaceuticals GmbH | Phase 2 |
| MerLion Pharmaceuticals GmbH | Phase 1 |
US Patents and Regulatory Information for FINAFLOXACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 FINAFLOXACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FINAFLOXACIN
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5980440 | ⤷ Sign Up | |
| Russian Federation | 2693476 | КОМПОЗИЦИИ ФИНАФЛОКСАЦИНА В ВИДЕ СУСПЕНЗИИ (FINAFLOXACIN SUSPENSION COMPOSITIONS) | ⤷ Sign Up |
| China | 104869999 | Finafloxacin suspension compositions | ⤷ Sign Up |
| Taiwan | 201102395 | Compositions and methods for treating ophthalmic, otic, or nasal infections | ⤷ Sign Up |
| European Patent Office | 2448587 | COMPOSITIONS COMPRENANT DE LA FINAFLOXACINE ET MÉTHODES DE TRAITEMENT D'INFECTIONS OPHTALMIQUES, OTIQUES OU NASALES (COMPOSITIONS COMPRISING FINAFLOXACIN AND METHODS FOR TREATING OPHTHALMIC, OTIC, OR NASAL INFECTIONS) | ⤷ Sign Up |
| Japan | 2012532115 | ⤷ Sign Up | |
| Japan | 2015134827 | 眼、耳または鼻の感染症を処置するためのフィナフロキサシンを含む組成物および方法 (COMPOSITIONS COMPRISING FINAFLOXACIN AND METHODS FOR TREATING OPHTHALMIC, OTIC, OR NASAL INFECTIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
