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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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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 |
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: ⤷ Sign Up
Australia
Patent: 11223095
Patent: Aqueous clear solutions of Fluocinolone Acetonide for treatment of otic inflammation
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012021638
Patent: composição livre de conservantes estéril ótica farmacêutica na forma de uma solução aquosa clara.
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 2811741
Patent: Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 66408
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Hong Kong
Patent: 62145
Patent: AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 44922
Estimated Expiration: ⤷ Sign Up
Patent: 13521245
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Poland
Patent: 66408
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 12141641
Patent: ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1777157
Estimated Expiration: ⤷ Sign Up
Patent: 130026430
Patent: AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 91721
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Denmark | 2366408 | ⤷ Sign Up | |
| 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) | ⤷ Sign Up |
| China | 102811741 | Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation | ⤷ Sign Up |
| Australia | 2011223095 | Aqueous clear solutions of Fluocinolone Acetonide for treatment of otic inflammation | ⤷ Sign Up |
| Mexico | 2012010009 | 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.) | ⤷ Sign Up |
| Russian Federation | 2549465 | ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ (AQUEOUS TRANSPARENT SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF EAR INFLAMMATION) | ⤷ Sign Up |
| Russian Federation | 2012141641 | ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Sign Up | 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 | 122012000070 | Germany | ⤷ Sign Up | 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 | 132013902137451 | Italy | ⤷ Sign Up | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
| 1429780 | 13C0012 | France | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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