OTOVEL Drug Patent Profile

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

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

See drug prices for OTOVEL

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

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.

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
Laboratorios 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
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)
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.)
Poland	2366408

Supplementary Protection Certificates for OTOVEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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

Market Dynamics and Financial Trajectory for OTOVEL

Introduction to OTOVEL

OTOVEL, a formulation of ciprofloxacin 0.3% and fluocinolone acetonide 0.025%, is a significant player in the treatment of acute otitis media, particularly in pediatric patients with tympanostomy tubes. Here, we delve into the market dynamics and financial trajectory of OTOVEL.

Market Context: Acute Otitis Media Treatment

The global acute otitis media treatment market has been on a growth trajectory, valued at US$ 1,943.9 million in 2016 and expected to grow at a Compound Annual Growth Rate (CAGR) of 5.1% from 2017 to 2025[1][4].

Launch and Impact

OTOVEL was launched in 2016 by Laboratorios SALVAT S.A. and Arbor Pharmaceuticals, LLC. This launch was a pivotal moment in the market, as it introduced a new treatment option for acute otitis media with tympanostomy tubes (AOMT) in pediatric patients. The introduction of OTOVEL has been a factor contributing to the growth of the acute otitis media treatment market[1][4].

Market Share and Regional Presence

The global acute otitis media treatment market is segmented by region, with North America and Europe being significant markets. The launch of OTOVEL has helped its manufacturers gain a notable market share in these regions. However, the exact market share of OTOVEL within the broader acute otitis media treatment market is not explicitly stated, but it is part of the growing segment driven by novel drug launches[1][4].

Competitive Landscape

The otic drugs market, including treatments for acute otitis media, is competitive with various players offering both branded and generic drugs. OTOVEL competes with other branded drugs as well as generic antibiotics like cefixime, which was approved by the US FDA in 2015. Despite this competition, the launch of novel drugs like OTOVEL has created a conducive environment for market growth[1][3].

Financial Performance

While specific financial figures for OTOVEL are not provided, the overall financial performance of the acute otitis media treatment market can give some insights. The market's growth is driven by the demand for effective treatments, and the launch of new products like OTOVEL contributes to this growth. The market size is expected to increase, driven by factors such as the rising prevalence of ear infections and advancements in drug formulations[1][3].

Revenue and Growth Projections

The global otic drugs market, which includes treatments for acute otitis media, is projected to reach $2.24 billion by 2028, growing at a CAGR of 7.0% from 2024 to 2028. This growth is driven by enhanced global healthcare access, increased investments in research and drug development, and a heightened focus on patient education and support[3].

Challenges and Opportunities

One of the major challenges for OTOVEL and other branded drugs in this market is the presence of generic drugs at lower prices. For instance, the approval of generic cefixime in 2015 posed a competitive threat to branded antibiotics. However, the launch of novel drugs and the focus on increasing online presence through educational resources and websites can help mitigate these challenges and expand the customer base[1].

Innovation and Market Trends

The market is witnessing several trends that could impact OTOVEL's trajectory. These include the management of antimicrobial resistance, the rise of targeted therapies, and innovative drug delivery methods. The emergence of personalized ear care and advanced solutions in drug development are also key trends shaping the future of the otic drugs market[3].

Key Takeaways

• Market Growth: The acute otitis media treatment market is growing, driven by the launch of novel drugs like OTOVEL.
• Competitive Landscape: OTOVEL competes with both branded and generic drugs in a competitive market.
• Financial Performance: The overall market growth indicates a positive financial trajectory for new and innovative treatments.
• Challenges and Opportunities: The presence of generic drugs and the need for continuous innovation are key factors to consider.
• Market Trends: Trends such as antimicrobial resistance management and personalized ear care are shaping the market.

FAQs

Q: What is OTOVEL used for? A: OTOVEL is used for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients.

Q: Who launched OTOVEL? A: OTOVEL was launched by Laboratorios SALVAT S.A. and Arbor Pharmaceuticals, LLC in 2016.

Q: What are the key drivers of the acute otitis media treatment market? A: The key drivers include the launch of novel drugs, rising prevalence of ear infections, and advancements in drug formulations.

Q: How does OTOVEL compete in the market? A: OTOVEL competes with both branded and generic antibiotics, with a focus on its unique formulation and targeted treatment benefits.

Q: What are the projected growth figures for the otic drugs market? A: The otic drugs market is projected to reach $2.24 billion by 2028, growing at a CAGR of 7.0% from 2024 to 2028.

Cited Sources

1. Coherent Market Insights: "Acute Otitis Media Treatment Market Size And Forecast To 2025"
2. GlobeNewswire: "Otic Drugs Market To Surge At A CAGR Of 7.0%: Global Growth Driven By Rising Prevalence Of Ear Infections And Innovations In Drug Formulations"
3. Coherent Market Insights: "Acute Otitis Media Treatment Market Size and Trends"