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Last Updated: January 28, 2023

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
Formulation / Manufacturing:see details
Drug Prices: Drug price information for OTOVEL
What excipients (inactive ingredients) are in OTOVEL?OTOVEL excipients list
DailyMed Link:OTOVEL at DailyMed
Drug patent expirations by year for OTOVEL
Drug Prices for OTOVEL

See drug prices for OTOVEL

DrugPatentWatch® Estimated Generic Entry Opportunity 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.

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 11223095
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012021638
Estimated Expiration: See Plans and Pricing

Canada

Patent: 90652
Estimated Expiration: See Plans and Pricing

China

Patent: 2811741
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 66408
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 66408
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 62145
Estimated Expiration: See Plans and Pricing

Japan

Patent: 44922
Estimated Expiration: See Plans and Pricing

Patent: 13521245
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12010009
Estimated Expiration: See Plans and Pricing

Poland

Patent: 66408
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 49465
Estimated Expiration: See Plans and Pricing

Patent: 12141641
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1777157
Estimated Expiration: See Plans and Pricing

Patent: 130026430
Estimated Expiration: See Plans and Pricing

Spain

Patent: 91721
Estimated Expiration: See Plans and Pricing

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
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.) See Plans and Pricing
Spain 2391721 See Plans and Pricing
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) See Plans and Pricing
Australia 2011223095 Aqueous clear solutions of Fluocinolone Acetonide for treatment of otic inflammation See Plans and Pricing
Poland 2366408 See Plans and Pricing
Denmark 2366408 See Plans and Pricing
European Patent Office 2366408 Solutions claires aqueuses d'ac├ętonide de fluocinolone pour le traitement de l'inflammation otique (Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OTOVEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 122012000070 Germany See Plans and Pricing 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 See Plans and Pricing 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 13C0012 France See Plans and Pricing 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 132013902137451 Italy See Plans and Pricing PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Moodys
Dow
Boehringer Ingelheim
Baxter

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.