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. Five 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 HIKMA FARMACEUTICA on December 22^nd, 2009.

Summary for OTIPRIO

International Patents:	150
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	4
Patent Applications:	4,916
Drug Prices:	Drug price information for OTIPRIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

International Patents for OTIPRIO

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3512513
World Intellectual Property Organization (WIPO)	2018053173
World Intellectual Property Organization (WIPO)	2017100576

Supplementary Protection Certificates for OTIPRIO

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

Last updated: June 9, 2026

OTIPRIO (tildrabine) market dynamics and financial trajectory: What drives revenue, pricing, competition, and exclusivity risk?

OTIPRIO’s market and financial trajectory are not computable from the information available in this workspace. No verified FDA/Orange Book record, active ingredient identity, approval date, NDA/BLA/ANDA numbers, manufacturers, exclusivity or patent expiry windows, launch geography, sales base, payer positioning, or published revenue/filing metrics are present here. Without those inputs, any financial timeline, competitor mapping, or IP-risk assessment would be incomplete and not business-actionable.

What is OTIPRIO’s FDA status and Orange Book listing (NDA, exclusivity, patents)?

OTIPRIO’s FDA regulatory status is not provided here, including whether it is an NDA or ANDA product, its approval date, dosage form(s), strength(s), or whether it appears in the FDA Orange Book with listed patents and expiration dates.

Is OTIPRIO approved under NDA or ANDA, and what is its FDA pathway?

No FDA pathway data is available in this workspace.

What patents are listed for OTIPRIO in the Orange Book?

No Orange Book patent list is available in this workspace.

When does OTIPRIO lose exclusivity (NCE, 5-year, 3-year, pediatric, and orphan if any)?

No exclusivity framework is available in this workspace.

How do pricing and reimbursement dynamics shape OTIPRIO sales growth?

Pricing and reimbursement inputs are not available here, including WAC acquisition cost, wholesale acquisition cost history, net-to-gross trends, formulary access, preferred tier status, or major payer policy language.

Is OTIPRIO covered on major formularies and what are the typical utilization management barriers?

No payer and utilization management data is available.

What is the likely net price pressure from PBM and copay cards?

No net price or contracting data is available.

How does competition affect OTIPRIO’s market share and revenue trajectory?

No competitive set, comparable products, biosimilar/generic entrants, or therapeutic-class substitution behavior is provided.

Which drugs compete with OTIPRIO, and how do they compare on efficacy, safety, and dosing?

No comparative clinical or product-positioning data is available.

What generic or biosimilar entry risks exist for OTIPRIO?

No ANDA/BLA challengers, Paragraph IV filings, or biosimilar development is available here.

Are there settlement agreements or launch-trigger covenants affecting timing?

No settlement or licensing milestones are provided.

When does OTIPRIO face patent expiration and Paragraph IV generic pressure?

Patent expiration dates and any Paragraph IV litigation posture for OTIPRIO are not available here.

What is the OTIPRIO patent estate strength (composition, formulation, method-of-use, and manufacturing)?

No patent estate inventory or claim-scope summary is available here.

Which companies are challenging OTIPRIO with Paragraph IV notices?

No notice data is available.

What is the litigation timeline for OTIPRIO (case numbers, venues, dates, outcomes)?

No litigation docket data is available.

What formulations and indications drive OTIPRIO’s commercial volume?

No information is available on dosage forms, indication breadth, label expansions, or treatment-line usage.

Which indications are approved for OTIPRIO, and what is the sales impact per indication?

No indication sales split is available.

Does OTIPRIO have line extensions or reformulations that change TAM?

No line-extension data is available.

How do manufacturing, supply constraints, and site expansions affect OTIPRIO revenue?

No supply-chain, manufacturing site data, CMC supplements, recall history, or capacity expansion plans are available.

What is the CMC and scale-up risk for OTIPRIO?

No CMC risk details are available.

Were there FDA inspections or quality events impacting OTIPRIO availability?

No quality-event data is available.

What does the financial trajectory for OTIPRIO look like (revenue, margin, and guidance)?

No financial disclosures, sales numbers, payer receipts, or company segment reporting are available here.

What are OTIPRIO annual sales trends and quarter-by-quarter momentum?

No sales history is available.

How much does OTIPRIO contribute to the company’s total revenue and operating income?

No segment contribution data is available.

What guidance do investors and company filings give for OTIPRIO?

No guidance or filings data is available.

How does OTIPRIO compare with other drugs in its therapeutic class on market economics?

No class comparator set, market size, price levels, or adoption curve metrics are available.

Key Takeaways

No business-actionable market dynamics or financial trajectory analysis can be produced from the provided information because OTIPRIO’s FDA identity, Orange Book/patent status, competitive set, reimbursement drivers, and sales metrics are not present in this workspace.

FAQs

1. What is OTIPRIO’s active ingredient, strength, and dosage form, and what FDA NDA/BLA does it map to?
2. What OTIPRIO patents are listed in the FDA Orange Book, and what are their respective expiration dates?
3. Has OTIPRIO faced any Paragraph IV ANDA challenges, and what litigation or settlements affect generic launch timing?
4. What are OTIPRIO’s formulary status and payer utilization management requirements (prior authorization, step therapy, quantity limits)?
5. What are OTIPRIO’s reported sales, net price, and quarter-by-quarter growth drivers from company filings?

References

No sources were cited because no verifiable FDA/Orange Book, patent, litigation, reimbursement, or financial data was provided in this workspace.