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-two patent family members in twenty countries.

The generic ingredient in OTIPRIO is ciprofloxacin. There are thirty-four drug master file entries for this compound. Six 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:	152
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	4
Patent Applications:	4,923
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		RX	Yes	Yes
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes			Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes			Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes			Y	Y
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		RX	Yes	Yes			Y

International Patents for OTIPRIO

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

Country	Patent Number	Title	Estimated Expiration
Japan	2017520584	シプロフロキサシン組成物の滅菌
United Kingdom	0907070
Canada	2731766	COMPOSITIONS ANTIMICROBIENNES A LIBERATION CONTROLEE ET PROCEDES POUR LE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE ANTIMICROBIAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS)
Japan	2019085423	耳の疾患と疾病を処置するための耳の製剤と関連する応用 (AURIS FORMULATION FOR TREATING OTIC DISEASE AND CONDITION AND APPLICATION RELATED THERETO)
South Korea	20200035508	귀 질환 및 병태를 치료하기 위한 귀 조제물 (AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS)
South Korea	101390607
Japan	6544535

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	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
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