OTOVEL Drug Patent Profile

Which patents cover Otovel, and when can generic versions of Otovel launch?

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

US Patents and Regulatory Information for OTOVEL

OTOVEL is protected by one US patents.

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			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
Poland	2366408
Russian Federation	2549465	ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ (AQUEOUS TRANSPARENT SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF EAR INFLAMMATION)
Spain	2391721
European Patent Office	2366408
South Korea	20130026430

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	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
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

Investment Scenario and Fundamentals Analysis for OTOVEL

Last updated: February 20, 2026

What is OTOVEL?

OTOVEL, with the generic name otilonium bromide, is a drug used primarily for the treatment of irritable bowel syndrome (IBS). It was initially developed for gastrointestinal motility disorders and is marketed in several countries, especially in Latin America and parts of Europe.

Market Overview

• Indication: Symptomatic relief of IBS-related abdominal pain and discomfort.
• Market Size: Estimated global IBS treatment market valued at $2.4 billion as of 2022, with a CAGR of 3.2% (Grand View Research).
• Geographic Focus: Dominant in Latin America, with commercialization in Spain, Italy, and Russia. Limited presence in North America and Asia.

Patent Status and Market Exclusivity

• Otilonium bromide's original patent expired in multiple jurisdictions between 2005-2010.
• In markets where patents have lapsed, generic competition has emerged.
• No recent patents strengthen exclusivity or provide additional market barriers.

Regulatory Environment

• Approved in Latin America, Europe, parts of Asia.
• No FDA approval for the U.S. market, limiting growth potential there.
• EU market access granted through national regulatory agencies; no centralized European approval.

Commercial Landscape

• Several generic formulations available in existing markets.
• Limited brand name manufacturers; mainly regional or local pharma companies.
• Minimal or no recent R&D activity for new formulations or indications.

Financial and Investment Considerations

Revenue and Operating Performance

• Little recent publicly available financial data; approximate sales in select markets ($20-50 million annually in Latin America).
• Margins are niche, constrained by generic competition.

R&D and Market Expansion

• No announced plans for new clinical trials or indications.
• Market entry in new regions unlikely without significant regulatory or formulation modifications.

Competitive Positioning

• Faces generic competition where patents have expired.
• No significant barriers to entry for competitors.

Investment Risks

• Patent expiry diminishing exclusivity.
• Limited pipeline and R&D activity.
• Regulatory constraints outside existing markets.
• Fragmentation with local competitors.

Investment Opportunities and Challenges

Opportunities	Challenges
Potential niche in IBS market in emerging markets	Heavy generic competition limits margins
Existing approval in multiple regions	Limited pipeline, no new indications planned
Low capital requirement for entry	Market size growth is moderate

Strategic Outlook

• Given patent expiry and lack of pipeline, OTOVEL's growth prospects are limited.
• Investment could be viable if positioned as a niche or if a company's regional distribution strength is leveraged.
• More suitable for players with an established presence in Latin American or European OTC gastrointestinal markets.

Key Takeaways

• OTOVEL operates in a mature, low-growth niche segment with limited exclusivity.
• Patent and regulatory expirations have eroded barriers to generic competition.
• The market is fragmented, with modest sales volumes and thin margins.
• No significant ongoing R&D suggests limited future value creation.
• Risk remains high for new entrants or investors without regional market penetration strategies.

FAQs

1. What are the main advantages of investing in OTOVEL?
Investors may benefit from existing regional market presence, especially in Latin America, where OTC gastrointestinal products have stable demand.

2. What are the primary risks associated with OTOVEL?
Patent expiration, high competition from generics, limited pipeline, and regulatory restrictions in potential new markets increase investment risk.

3. Is there potential for new formulations or indications?
Currently, no public announcements indicate R&D efforts for new formulations or indications, limiting future growth.

4. How does OTOVEL compare to other IBS treatments?
OTOVEL’s market share is small compared to newer prescription drugs and alternative therapies, which have stronger clinical data and patent protection.

5. What markets present growth opportunities for OTOVEL?
Latin America and select European markets may sustain modest sales; growth in emerging markets depends on regulatory approval and local acceptance.

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References

1. Grand View Research. (2022). IBS Treatment Market Size, Share & Trends Analysis.
2. European Medicines Agency. (2022). Approved Drugs List.
3. U.S. Food and Drug Administration. (2022). Regulatory Status of Gastrointestinal Drugs.
4. MarketWatch. (2023). Generic Pharmaceuticals Market Data.
5. IBISWorld. (2023). Gastroenterology Market in Latin America.