OTIPRIO Drug Patent Profile

When do Otiprio patents expire, and when can generic versions of Otiprio launch?

Otiprio is a drug marketed by Alk Abello and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and fifty patent family members in twenty countries.

The generic ingredient in OTIPRIO is ciprofloxacin. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Otiprio

A generic version of OTIPRIO was approved as ciprofloxacin by BAXTER HLTHCARE CORP on April 29^th, 2008.

Summary for OTIPRIO

International Patents:	150
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	4
Patent Applications:	5,378
Drug Prices:	Drug price information for OTIPRIO
What excipients (inactive ingredients) are in OTIPRIO?	OTIPRIO excipients list
DailyMed Link:	OTIPRIO at DailyMed

See drug prices for OTIPRIO

Recent Clinical Trials for OTIPRIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boston Medical Center	Phase 4
Otonomy, Inc.	Phase 2
Otonomy, Inc.	Phase 3

See all OTIPRIO clinical trials

US Patents and Regulatory Information for OTIPRIO

OTIPRIO is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	8,318,817
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	9,220,796		Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	11,040,004
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	9,233,068		Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	9,603,796		Y	Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	9,205,048

International Patents for OTIPRIO

See the table below for patents covering OTIPRIO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019275578	Sterilization of ciprofloxacin composition
Japan	5421366
Brazil	PI0915770	composição de modulação de apoptose de liberação controlada e métodos para o tratamento de distúrbios ótológicos
World Intellectual Property Organization (WIPO)	2010008995
Argentina	071388	FORMULACIONES PARA EL OIDO PARA EL TRATAMIENTO DE ENFERMEDADES Y CONDICIONES OTICAS. DISPOSITIVO. METODO
United Kingdom	2461186	Sustained release composition for intratympanic delivery of corticosteroid

Supplementary Protection Certificates for OTIPRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

OTIPRIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OTIPRIO

Introduction to OTIPRIO

OTIPRIO® (ciprofloxacin otic suspension) is a sterile, preservative-free otic suspension developed for the treatment of acute otitis externa (AOE) due to Pseudomonas aeruginosa and Staphylococcus aureus in patients six months of age and older. This innovative drug has been a significant player in the otic drugs market, particularly in the treatment of ear infections.

Acquisition and Market Expansion

In a strategic move to broaden its treatment solutions, ALK, a global pharmaceutical company specializing in allergy diagnosis and treatment, acquired OTIPRIO from Otonomy, Inc. in June 2020. This acquisition included an exclusive agreement for the co-promotion of OTIPRIO, which has expanded ALK's portfolio to offer more innovative solutions to healthcare providers, including ENTs, primary care physicians, and pediatricians[1].

Market Growth and Projections

The otic drugs market, within which OTIPRIO operates, is experiencing robust growth. According to The Business Research Company, the otic drugs market is projected to reach $2.24 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 7.0% from 2024 to 2028. This growth is driven by factors such as the rising prevalence of ear infections, advancements in drug formulations, and enhanced global healthcare access[3].

Key Drivers of Growth

Prevalence of Ear Infections

The escalating prevalence of ear infections is a significant driver for the growth of the otic drugs market. Ear infections affect millions globally, and the demand for targeted and efficient treatments continues to rise. The World Health Organization estimates that by 2050, 2.5 billion people will experience hearing loss, with at least 700 million requiring treatment[3].

Innovations in Drug Formulations

OTIPRIO itself is an example of innovative drug formulation. It is a thermosensitive suspension that exists as a liquid at or below room temperature and gels when warmed, making it an effective single-dose treatment administered by healthcare professionals[1].

Impact of COVID-19

The COVID-19 pandemic has also influenced the market dynamics. While it caused disruptions in healthcare services, it also highlighted the importance of treating otitis media, which can be a manifestation or associated symptom of COVID-19. This has led to an increased demand for drugs like OTIPRIO[4].

Financial Performance and Funding

Otonomy's Financial Position

Before the acquisition, Otonomy, Inc. had a strong financial position. In 2020, Otonomy completed an underwritten public offering that raised approximately $69.1 million in gross proceeds. The company also amended its term loan with Oxford Finance LLC to extend the interest-only repayment period, which helped in managing its financial obligations[2].

ALK's Investment and Strategy

ALK's acquisition of OTIPRIO was part of its strategy to broaden its commercial footprint in the U.S. with novel first-in-class products. This move is expected to enhance ALK's revenue streams and expand its market presence in the otic drugs segment[1].

Market Segmentation and End-Users

The otic drugs market, including OTIPRIO, is segmented based on drug class, indication, route of administration, and end-users. OTIPRIO falls under the category of otic anti-infectives and is primarily administered topically. The key end-users include hospitals, specialty clinics, and homecare settings[3].

Geographical Landscape

North America holds the largest share in the otic drugs market, and OTIPRIO is a significant player in this region. The Asia-Pacific region is anticipated to be the fastest-growing market in the forecast period, driven by increasing healthcare access and investments in research and drug development[3].

Competitive Landscape

The otic drugs market is competitive, with major players such as Pfizer Inc., Johnson & Johnson Limited, and Merck and Co. Inc. innovating in drug formulations and delivery methods. OTIPRIO, with its unique thermosensitive properties, stands out as a competitive product in this market[3].

Key Takeaways

• Market Growth: The otic drugs market is projected to grow at a CAGR of 7.0% from 2024 to 2028.
• Innovative Formulation: OTIPRIO's thermosensitive suspension makes it a unique and effective treatment for acute otitis externa.
• Financial Strength: The acquisition by ALK and Otonomy's previous financial position indicate a strong financial trajectory.
• Market Segmentation: OTIPRIO is part of the otic anti-infectives segment, with key end-users including hospitals and specialty clinics.
• Geographical Expansion: North America is the largest market, with Asia-Pacific expected to be the fastest-growing region.

FAQs

1. What is OTIPRIO used for? OTIPRIO is used for the treatment of acute otitis externa (AOE) due to Pseudomonas aeruginosa and Staphylococcus aureus in patients six months of age and older.

2. Who acquired OTIPRIO? ALK, a global pharmaceutical company, acquired OTIPRIO from Otonomy, Inc. in June 2020.

3. What is the projected growth rate of the otic drugs market? The otic drugs market is expected to grow at a CAGR of 7.0% from 2024 to 2028.

4. How does OTIPRIO's formulation work? OTIPRIO is a thermosensitive suspension that exists as a liquid at or below room temperature and gels when warmed, making it an effective single-dose treatment.

5. What are the key drivers of growth for the otic drugs market? The key drivers include the rising prevalence of ear infections, advancements in drug formulations, and enhanced global healthcare access.

Sources

1. ALK Acquires OTIPRIO® (ciprofloxacin otic suspension) from Otonomy - BioSpace
2. Otonomy Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update - GlobeNewswire
3. Otic Drugs Market To Surge At A CAGR Of 7.0% - GlobeNewswire
4. Global Acute Otitis Media Treatment Market Size - Mordor Intelligence