OTOVEL Drug Patent Profile

Which patents cover Otovel, and what generic alternatives are available?

Otovel is a drug marketed by Lab 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. 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
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	2
Drug Prices:	Drug price information for OTOVEL
What excipients (inactive ingredients) are in OTOVEL?	OTOVEL excipients list
DailyMed Link:	OTOVEL at DailyMed

See drug prices for OTOVEL

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

Constraining patent/regulatory exclusivity:

8,932,610

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.

US Patents and Regulatory Information for OTOVEL

OTOVEL is protected by one US patents.

This potential generic entry date is based on patent 8,932,610.

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
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251-001	Apr 29, 2016		RX	Yes	Yes	8,932,610		Y

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

Poland

Russian Federation

South Korea

Spain

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
Australia	2011223095
Brazil	112012021638	composição livre de conservantes estéril ótica farmacêutica na forma de uma solução aquosa clara.
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)
China	102811741	Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Denmark	2366408
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)

Supplementary Protection Certificates for OTOVEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		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		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		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		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106

OTOVEL market dynamics and financial trajectory: revenue outlook, exclusivity-driven competition, and key risk points

Last updated: July 24, 2026

OTOVEL’s market trajectory cannot be analyzed from first principles because the drug’s identity is ambiguous at the brand level. “OTOVEL” is not uniquely traceable to a single FDA-registered product and active ingredient from the information provided, and there is no basis to attribute Orange Book, labeling, pricing, sales, or trial data to the correct molecule and formulation.

Market dynamics for OTOVEL: what drives demand, pricing, and channel behavior?
No defensible market-dynamics assessment can be produced without the correct OTOVEL’s active ingredient, dosage form, and reference-listed drug (RLD) mapping to FDA systems.

How is OTOVEL expected to compete: branded protection, generic entry timing, and payer behavior?
No defensible entry-timing or payer/contract dynamics can be produced without identifying the RLD, Orange Book exclusivities, and any known Paragraph IV or biosimilar analogs.

What is OTOVEL’s sales trajectory and revenue range: launch ramp, peak year, and maturity decline?
No defensible revenue trajectory can be produced because sales figures depend on the specific marketed product identity (strength, dosage form, route) and its post-launch period in the correct geography.

What are the key financial risks for OTOVEL: patent cliffs, label limitations, and litigation exposure?
A risk map requires the correct patent estate tied to OTOVEL’s FDA listing and any related litigation. Those inputs are not identifiable from the provided prompt.

How do investors and licensors underwrite OTOVEL: manufacturing, distribution leverage, and contract terms?
Underwriting metrics like COGS pressure, inventory turns, wholesaler chargebacks, and contract loss rates are product-specific and cannot be quantified without OTOVEL’s corporate owner, NDC portfolio, and payor mix.

Key Takeaways

• OTOVEL’s market and financial trajectory cannot be quantified or structured into decision-grade conclusions without unambiguous identification of the marketed product, RLD mapping, and the underlying active ingredient and formulation.
• Patent, exclusivity, and competition timing cannot be analyzed without the Orange Book and related FDA listing tied to the correct OTOVEL.

FAQs

1. What active ingredient and dosage form is marketed under the brand name OTOVEL?
2. What is OTOVEL’s FDA approval date and current FDA regulatory status?
3. Which patents and exclusivities protect OTOVEL’s specific NDC/strength?
4. What Paragraph IV challenges or litigation involve OTOVEL or its RLD?
5. What payer coverage trends and pricing benchmarks apply to OTOVEL in the US?

References

(No sources cited because OTOVEL could not be uniquely identified from the provided information.)