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: | 4,478 |
| 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 |
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 |
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 |
|---|---|---|---|
| European Patent Office | 2299979 | COMPOSITIONS ANTIMICROBIENNES À LIBÉRATION CONTRÔLÉE ET PROCÉDÉS POUR LE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE ANTIMICROBIAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS) | ⤷ Sign Up |
| Peru | 20100137 | COMPOSICIONES ANTIMICROBIANAS DE LIBERACION CONTROLADA Y METODOS PARA EL TRATAMIENTO DE TRASTORNOS OTICOS | ⤷ Sign Up |
| Japan | 2016153423 | 制御放出型コルチコステロイド組成物、および耳の疾患を処置する方法 (CONTROLLED RELEASE CORTICOSTEROID COMPOSITIONS AND METHODS FOR TREATMENT OF OTIC DISORDERS) | ⤷ Sign Up |
| Australia | 2009246870 | Controlled release corticosteroid compositions and methods for the treatment of otic disorders | ⤷ Sign Up |
| Hong Kong | 1215394 | 控制釋放型耳結構調節和先天性免疫系統調節組合物、裝置以及治療耳部病症的方法 (CONTROLLED-RELEASE OTIC STRUCTURE MODULATING AND INNATE IMMUNE SYSTEM MODULATING COMPOSITIONS, DEVICES, 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 | 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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