OTIPRIO Drug Patent Profile

When do Otiprio patents expire, and what generic alternatives are available?

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 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:	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

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

Anatomical Therapeutic Chemical (ATC) Classes for OTIPRIO

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for OTIPRIO

OTIPRIO is protected by eight US patents.

Patents protecting OTIPRIO

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
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No			Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No			Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No			Y	Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No			Y

International Patents for OTIPRIO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101367479
Mexico	2010011545	FORMULACIONES PARA TRATAR ENFERMEDADES Y AFECCIONES DEL OIDO. (AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS.)
European Patent Office	2299976	COMPOSITIONS DE MODULATEUR DE CELLULES SENSORIELLES AURICULAIRES À LIBÉRATION CONTRÔLÉE ET PROCÉDÉS DE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE AURIS SENSORY CELL MODULATOR COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS)
Japan	5551685
Canada	2954170	STERILISATION D'UNE COMPOSITION DE CIPROFLOXACINE (STERILIZATION OF CIPROFLOXACIN COMPOSITION)
Peru	20091836	FORMULACIONES PARA EL OIDO PARA TRATAR ENFERMEDADES Y CONDICIONES OTICAS
Taiwan	201004633	Auris formulations for treating otic diseases and conditions

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	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