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
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Questions you can ask:
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Summary for OTOVEL
International Patents: | 18 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Drug Prices: | Drug price information 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 |
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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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
Patent: DISOLUCIONES ACUOSAS TRANSPARENTES DE ACETONIDO DE FLUOCINOLONA PARA EL TRATAMIENTO DE LA INFLAMACION DE OIDO
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 11223095
Patent: Aqueous clear solutions of Fluocinolone Acetonide for treatment of otic inflammation
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2012021638
Patent: composição livre de conservantes estéril ótica farmacêutica na forma de uma solução aquosa clara.
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 90652
Patent: SOLUTIONS TRANSPARENTES AQUEUSES DE FLUOCINOLONE ACETONIDE DANS LE TRAITEMENT DE L'INFLAMMATION OTIQUE (AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION)
Estimated Expiration: ⤷ Subscribe
China
Patent: 2811741
Patent: Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 66408
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 66408
Patent: Solutions claires aqueuses d'acétonide de fluocinolone pour le traitement de l'inflammation otique (Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation)
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 62145
Patent: AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 44922
Estimated Expiration: ⤷ Subscribe
Patent: 13521245
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 12010009
Patent: DISOLUCIONES ACUOSAS TRANSPARENTES DE ACETONIDO DE FLUOCINOLONA PARA EL TRATAMIENTO DE LA INFLAMACION DE OIDO. (AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION.)
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 66408
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 49465
Patent: ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ (AQUEOUS TRANSPARENT SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF EAR INFLAMMATION)
Estimated Expiration: ⤷ Subscribe
Patent: 12141641
Patent: ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1777157
Estimated Expiration: ⤷ Subscribe
Patent: 130026430
Patent: AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 91721
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Japan | 2013521245 | ⤷ Subscribe | |
Hong Kong | 1162145 | AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION | ⤷ Subscribe |
Brazil | 112012021638 | composição livre de conservantes estéril ótica farmacêutica na forma de uma solução aquosa clara. | ⤷ Subscribe |
Russian Federation | 2012141641 | ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ | ⤷ Subscribe |
Spain | 2391721 | ⤷ Subscribe | |
South Korea | 20130026430 | AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1429780 | 132013902137451 | Italy | ⤷ Subscribe | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
1429780 | 13C0012 | France | ⤷ Subscribe | 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 | 122012000070 | Germany | ⤷ Subscribe | PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808 |
1429780 | SPC/GB12/058 | United Kingdom | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
OTOVEL Market Analysis and Financial Projection Experimental
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