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Last Updated: May 28, 2024

OTIPRIO Drug Patent Profile


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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 BAXTER HLTHCARE CORP on April 29th, 2008.

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Summary for OTIPRIO
International Patents:150
US Patents:8
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 123
Clinical Trials: 4
Patent Applications: 4,524
Formulation / Manufacturing:see details
Drug Prices: Drug price information for OTIPRIO
What excipients (inactive ingredients) are in OTIPRIO?OTIPRIO excipients list
DailyMed Link:OTIPRIO at DailyMed
Drug patent expirations by year for OTIPRIO
Drug Prices for OTIPRIO

See drug prices for OTIPRIO

Recent Clinical Trials for OTIPRIO

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

SponsorPhase
Boston Medical CenterPhase 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.

Patents protecting OTIPRIO

Otic gel formulations for treating otitis externa
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF OTIC INFECTION OR INFLAMMATION

Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS WITH OTITIS MEDIA WITH EFFUSION UNDERGOING TYMPANOSTOMY TUBE PLACEMENT

Sterilization of ciprofloxacin composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OTIPRIO

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

Country Patent Number Title Estimated Expiration
South Korea 20130100017 CONTROLLED RELEASE CORTICOSTEROID COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010074992 ⤷  Sign Up
Australia 2009274229 Controlled-release otic structure modulating and innate immune system modulating compositions and methods for the treatment of otic disorders ⤷  Sign Up
Japan 2014101392 CONTROLLED RELEASE-TYPE CORTICOSTEROID COMPOSITION AND METHOD FOR TREATING EAR DISEASE ⤷  Sign Up
China 102105133 Controlled-release otic structure modulating and innate immune system modulating compositions and methods for the treatment of otic disorders ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OTIPRIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 122012000070 Germany ⤷  Sign Up 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 13C0012 France ⤷  Sign Up 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 132013902137451 Italy ⤷  Sign Up PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 SPC/GB12/058 United Kingdom ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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