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OTOVEL Drug Profile
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Which patents cover Otovel, and what generic alternatives are available?
Otovel is a drug marketed by Laboratorios Salvat and is included in one NDA. There is one patent protecting this drug.
This drug has eighteen patent family members in fifteen countries.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
US ANDA Litigation and Generic Entry Outlook for Otovel
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 24, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for OTOVEL
| International Patents: | 18 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OTOVEL |
| DailyMed Link: | OTOVEL at DailyMed |
Generic Entry Opportunity Date for OTOVEL
Generic Entry Date for OTOVEL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/DROPS;OTIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for OTOVEL
| Drug Class | Quinolone Antimicrobial Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for OTOVEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Laboratorios Salvat | OTOVEL | ciprofloxacin hydrochloride; fluocinolone acetonide | SOLUTION/DROPS;OTIC | 208251-001 | Apr 29, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 OTOVEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2549465 | Start Trial |
| Brazil | 112012021638 | Start Trial |
| Australia | 2011223095 | Start Trial |
| Canada | 2790652 | Start Trial |
| Russian Federation | 2012141641 | Start Trial |
| Hong Kong | 1162145 | Start Trial |
| South Korea | 20130026430 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | 132013902137451 | Italy | Start Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
| 1429780 | SPC/GB12/058 | United Kingdom | Start Trial | 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 | 13C0012 | France | Start Trial | 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 | Start Trial | PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
