OZENOXACIN - Generic Drug Details
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What are the generic drug sources for ozenoxacin and what is the scope of freedom to operate?
Ozenoxacin
is the generic ingredient in one branded drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ozenoxacin has thirty-seven patent family members in twenty-three countries.
There is one drug master file entry for ozenoxacin.
Summary for OZENOXACIN
| International Patents: | 37 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 2 |
| Patent Applications: | 136 |
| What excipients (inactive ingredients) are in OZENOXACIN? | OZENOXACIN excipients list |
| DailyMed Link: | OZENOXACIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OZENOXACIN
*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 OZENOXACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ferrer Internacional S.A. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for OZENOXACIN
US Patents and Regulatory Information for OZENOXACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ferrer Internacional | XEPI | ozenoxacin | CREAM;TOPICAL | 208945-001 | Dec 11, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Ferrer Internacional | XEPI | ozenoxacin | CREAM;TOPICAL | 208945-001 | Dec 11, 2017 | RX | Yes | Yes | ⤷ 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 OZENOXACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ferrer Internacional | XEPI | ozenoxacin | CREAM;TOPICAL | 208945-001 | Dec 11, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OZENOXACIN
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Chile | 2011000848 | Composicion de crema topica estable que comprende ozenoxacina y un excipiente farmaceuticamente adecuado y uso de la composicion para la erradicacion de infecciones nasofaringeas en portadores nasales asintomaticos, y para el tratamiento o prevencion de infecciones de la piel, del tracto genital, y enfermedades de transmision sexual. | ⤷ Sign Up |
| Russian Federation | 2011119764 | СТАБИЛЬНАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ), ЛЕКАРСТВЕННОЕ СРЕДСТВО (ВАРИАНТЫ) И СПОСОБЫ ЛЕЧЕНИЯ И ПРОФИЛАКТИКИ КОЖНЫХ ИНФЕКЦИЙ И ИНФЕКЦИЙ КОЖНЫХ СТРУКТУР, ЗАБОЛЕВАНИЙ, ПЕРЕДАЮЩИХСЯ ПОЛОВЫМ ПУТЕМ И ИНФЕКЦИЙ ПОЛОВЫХ ПУТЕЙ, ИНФЕКЦИЙ НОСОГЛОТКИ У ЧЕЛОВЕКА ИЛИ ЖИВОТНОГО | ⤷ Sign Up |
| South Korea | 20110071086 | PHARMACEUTICAL TOPICAL COMPOSITIONS | ⤷ Sign Up |
| South Korea | 101682256 | ⤷ Sign Up | |
| Japan | 5873120 | ⤷ Sign Up | |
| European Patent Office | 2177208 | Compositions pharmaceutiques topiques (Pharmaceutical topical compositions) | ⤷ Sign Up |
| European Patent Office | 2344130 | COMPOSITIONS PHARMACEUTIQUES TOPIQUES (PHARMACEUTICAL TOPICAL COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OZENOXACIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2344130 | 1790031-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519 |
| 2344130 | 2017/038 | Ireland | ⤷ Sign Up | PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519 |
| 2344130 | 122017000073 | Germany | ⤷ Sign Up | PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517 |
| 2344130 | 2017C/031 | Belgium | ⤷ Sign Up | PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519 |
| 2344130 | 300884 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519 |
| 2344130 | 132017000093887 | Italy | ⤷ Sign Up | PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711 |
| 2344130 | C201730036 | Spain | ⤷ Sign Up | PRODUCT NAME: OZENOXACINO; NATIONAL AUTHORISATION NUMBER: 82357-ES/H/0414/001/DC; DATE OF AUTHORISATION: 20170830; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): ES/H/414/01/DC; DATE OF FIRST AUTHORISATION IN EEA: 20170519 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
