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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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OTOVEL

Generic Entry Date for OTOVEL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208251 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 ⤷ 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

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Glossary

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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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2011223095	Aqueous clear solutions of Fluocinolone Acetonide for treatment of otic inflammation	⤷ Sign Up
European Patent Office	2366408	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)	⤷ Sign Up
South Korea	20130026430	AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OTOVEL

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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	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
1429780	132013902137451	Italy	⤷ Sign Up	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