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.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-one 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
| 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
| Ingredient-type | Quinolones |
| 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 |
|---|---|---|
| European Patent Office | 2366408 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 2011107436 | ➤ Try a Free Trial |
| Argentina | 080368 | ➤ Try a Free Trial |
| Mexico | 2012010009 | ➤ Try a Free Trial |
| South Korea | 20130026430 | ➤ Try a Free Trial |
| Hong Kong | 1162145 | ➤ Try a Free Trial |
| Spain | 2391721 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for OTOVEL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
