DrugPatentWatch Database Preview
OTOVEL Drug Profile
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 sixteen patent family members in thirteen countries.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
Summary for OTOVEL
| International Patents: | 16 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| 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:
NEW COMBINATION 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Laboratorios Salvat | OTOVEL | ciprofloxacin hydrochloride; fluocinolone acetonide | SOLUTION/DROPS;OTIC | 208251-001 | Apr 29, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2790652 | ➤ Try a Free Trial |
| Australia | 2011223095 | ➤ Try a Free Trial |
| China | 102811741 | ➤ Try a Free Trial |
| Japan | 5744922 | ➤ Try a Free Trial |
| Russian Federation | 2012141641 | ➤ Try a Free Trial |
| Mexico | 2012010009 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB12/058 | United Kingdom | ➤ Try a Free 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 |
| C0012 | France | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
