XEPI Drug Patent Profile
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Which patents cover Xepi, and what generic alternatives are available?
Xepi is a drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-seven patent family members in twenty-three countries.
The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ozenoxacin profile page.
DrugPatentWatch® Generic Entry Outlook for Xepi
Xepi was eligible for patent challenges on December 11, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 29, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XEPI
International Patents: | 37 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Patent Applications: | 68 |
What excipients (inactive ingredients) are in XEPI? | XEPI excipients list |
DailyMed Link: | XEPI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XEPI
Generic Entry Date for XEPI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL |
*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.
Pharmacology for XEPI
Drug Class | Quinolone Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for XEPI
US Patents and Regulatory Information for XEPI
XEPI is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XEPI is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting XEPI
Pharmaceutical topical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
Pharmaceutical topical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferrer Internacional | XEPI | ozenoxacin | CREAM;TOPICAL | 208945-001 | Dec 11, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 XEPI
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ferrer Internacional | XEPI | ozenoxacin | CREAM;TOPICAL | 208945-001 | Dec 11, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XEPI
When does loss-of-exclusivity occur for XEPI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3901
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09305360
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0920355
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 38384
Estimated Expiration: ⤷ Try a Trial
Patent: 22167
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11000848
Estimated Expiration: ⤷ Try a Trial
Patent: 15002899
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2186460
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 14838
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 44130
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 77208
Estimated Expiration: ⤷ Try a Trial
Patent: 44130
Estimated Expiration: ⤷ Try a Trial
Patent: 70117
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 61552
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09209
Estimated Expiration: ⤷ Try a Trial
Patent: 73120
Estimated Expiration: ⤷ Try a Trial
Patent: 12505867
Estimated Expiration: ⤷ Try a Trial
Patent: 14088456
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 8029
Estimated Expiration: ⤷ Try a Trial
Patent: 11004052
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0884
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014502425
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 44130
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 44130
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 78367
Estimated Expiration: ⤷ Try a Trial
Patent: 11119764
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 44130
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1682256
Estimated Expiration: ⤷ Try a Trial
Patent: 110071086
Estimated Expiration: ⤷ Try a Trial
Patent: 160025034
Estimated Expiration: ⤷ Try a Trial
Patent: 160116353
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 37967
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 04418
Estimated Expiration: ⤷ Try a Trial
Patent: 1018497
Estimated Expiration: ⤷ Try a Trial
Patent: 1511779
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 187
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering XEPI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5873120 | ⤷ Try a Trial | |
Brazil | PI0920355 | composições farmacêuticas tópicas estáveis de ozenoxacina e uso de ozenoxacina | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9951588 | ⤷ Try a Trial | |
Portugal | 2344130 | ⤷ Try a Trial | |
Canada | 2327328 | DERIVES D'ACIDE QUINOLONECARBOXYLIQUE OU SELS DE CEUX-CI (QUINOLONECARBOXYLIC ACID DERIVATIVES OR SALTS THEREOF) | ⤷ Try a Trial |
Japan | 5509209 | ⤷ Try a Trial | |
Denmark | 1070713 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XEPI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2344130 | C201730036 | Spain | ⤷ Try a Trial | 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 |
2344130 | 1790031-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519 |
2344130 | 2017/038 | Ireland | ⤷ Try a Trial | PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519 |
2344130 | 132017000093887 | Italy | ⤷ Try a Trial | PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711 |
2344130 | 122017000073 | Germany | ⤷ Try a Trial | PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517 |
2344130 | 2017C/031 | Belgium | ⤷ Try a Trial | PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519 |
2344130 | 300884 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |