Otovel Patent Expiration

Otovel is a drug owned by Laboratorios Salvat Sa. It is protected by 1 US drug patent filed in 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 24, 2030. Details of Otovel's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8932610 Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Mar, 2030

(5 years from now)


FDA has granted several exclusivities to Otovel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Otovel, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Otovel.

Exclusivity Information

Otovel holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Otovel's exclusivity codes and their expiration dates are given below.

Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Apr 29, 2019

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US patents provide insights into the exclusivity only within the United States, but Otovel is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Otovel's family patents as well as insights into ongoing legal events on those patents.

Otovel's family patents

Otovel has patent protection in a total of 15 countries. It's US patent count contributes only to 6.2% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Otovel.

Family Patents

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Generic Launch

Generic Release Date:

Otovel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 24, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Otovel Generics:

There are no approved generic versions for Otovel as of now.

About Otovel

Otovel is a drug owned by Laboratorios Salvat Sa. It is used for treating acute otitis media. Otovel uses Ciprofloxacin Hydrochloride; Fluocinolone Acetonide as an active ingredient. Otovel was launched by Laboratorios Salvat in 2016.

Market Authorisation Date:

Otovel was approved by FDA for market use on 29 April, 2016.

Active Ingredient:

Otovel uses Ciprofloxacin Hydrochloride; Fluocinolone Acetonide as the active ingredient. Check out other Drugs and Companies using Ciprofloxacin Hydrochloride; Fluocinolone Acetonide ingredient


Otovel is used for treating acute otitis media.


Otovel is available in solution/drops form for otic use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.3% BASE;0.025% SOLUTION/DROPS Prescription OTIC