OTOVEL Drug Patent Profile
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Which patents cover Otovel, and what generic alternatives are available?
Otovel is a drug marketed by Laboratorios Salvat and is included in one NDA. There is one patent protecting this drug.
This drug has eighteen patent family members in fifteen countries.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
DrugPatentWatch® Generic Entry Outlook for Otovel
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 24, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for OTOVEL
International Patents: | 18 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OTOVEL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTOVEL |
What excipients (inactive ingredients) are in OTOVEL? | OTOVEL excipients list |
DailyMed Link: | OTOVEL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OTOVEL
Generic Entry Date for OTOVEL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/DROPS;OTIC |
*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 OTOVEL
Drug Class | Corticosteroid Fluoroquinolone Antibacterial |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OTOVEL
US Patents and Regulatory Information for OTOVEL
OTOVEL is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OTOVEL 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 OTOVEL
Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE OTITIS MEDIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Laboratorios Salvat | OTOVEL | ciprofloxacin hydrochloride; fluocinolone acetonide | SOLUTION/DROPS;OTIC | 208251-001 | Apr 29, 2016 | 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 |
International Patents for OTOVEL
When does loss-of-exclusivity occur for OTOVEL?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0368
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 11223095
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012021638
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 90652
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2811741
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 66408
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 66408
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 62145
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 44922
Estimated Expiration: ⤷ Try a Trial
Patent: 13521245
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12010009
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 66408
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 49465
Estimated Expiration: ⤷ Try a Trial
Patent: 12141641
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1777157
Estimated Expiration: ⤷ Try a Trial
Patent: 130026430
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 91721
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 OTOVEL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 080368 | DISOLUCIONES ACUOSAS TRANSPARENTES DE ACETONIDO DE FLUOCINOLONA PARA EL TRATAMIENTO DE LA INFLAMACION DE OIDO | ⤷ Try a Trial |
Poland | 2366408 | ⤷ Try a Trial | |
Hong Kong | 1162145 | AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION | ⤷ Try a Trial |
Japan | 2013521245 | ⤷ Try a Trial | |
South Korea | 20130026430 | AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION | ⤷ Try a Trial |
Canada | 2790652 | SOLUTIONS TRANSPARENTES AQUEUSES DE FLUOCINOLONE ACETONIDE DANS LE TRAITEMENT DE L'INFLAMMATION OTIQUE (AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1429780 | 13C0012 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
1429780 | SPC/GB12/058 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
1429780 | 132013902137451 | Italy | ⤷ Try a Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
1429780 | 122012000070 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |