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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8932610 | Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation |
Mar, 2030
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Otovel's patents.
Latest Legal Activities on Otovel's Patents
Given below is the list of recent legal activities going on the following patents of Otovel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 13 Jul, 2022 | US8932610 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Jul, 2018 | US8932610 |
| Recordation of Patent Grant Mailed | 13 Jan, 2015 | US8932610 |
| Patent Issue Date Used in PTA Calculation | 13 Jan, 2015 | US8932610 |
| Email Notification | 25 Dec, 2014 | US8932610 |
| Issue Notification Mailed | 23 Dec, 2014 | US8932610 |
| Dispatch to FDC | 15 Dec, 2014 | US8932610 |
| Application Is Considered Ready for Issue | 12 Dec, 2014 | US8932610 |
| Printer Rush- No mailing | 12 Dec, 2014 | US8932610 |
| Information Disclosure Statement considered | 11 Dec, 2014 | US8932610 |
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 |
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
Explore Our Curated Drug Screens
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.
Alternative Brands for Otovel
Otovel which is used for treating acute otitis media., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Sandoz |
| |||
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 Lab Salvat in 2016.
Approval 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
Treatment:
Otovel is used for treating acute otitis media.
Dosage:
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 |