Otiprio is a drug owned by Alk-abello Inc. It is protected by 8 US drug patents filed from 2015 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 27, 2038. Details of Otiprio's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9603796 | Controlled release antimicrobial compositions and methods for the treatment of otic disorders |
Apr, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11369566 | Controlled release antimicrobial compositions and methods for the treatment of otic disorders |
Apr, 2029
(4 years from now) | Active |
| US9205048 | Controlled release antimicrobial compositions and methods for the treatment of otic disorders |
Apr, 2029
(4 years from now) | Active |
| US9233068 | Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders |
Dec, 2029
(5 years from now) | Active |
| US8318817 | Controlled release antimicrobial compositions and methods for the treatment of otic disorders |
Apr, 2030
(5 years from now) | Active |
| US9220796 | Sterilization of ciprofloxacin composition |
Jul, 2035
(10 years from now) | Active |
| US11040004 | Otic gel formulations for treating otitis externa |
Nov, 2037
(13 years from now) | Active |
| US11246863 | Ciprofloxacin otic composition and kits and method for using same |
Nov, 2038
(14 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 Otiprio's patents.
Latest Legal Activities on Otiprio's Patents
Given below is the list of recent legal activities going on the following patents of Otiprio.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 05 Feb, 2024 | US9220796 |
| Expire Patent | 15 Jan, 2024 | US9205048 |
| Maintenance Fee Reminder Mailed | 21 Aug, 2023 | US9220796 |
| Maintenance Fee Reminder Mailed | 31 Jul, 2023 | US9205048 |
| Patent Issue Date Used in PTA Calculation | 28 Jun, 2022 | US11369566 |
| Recordation of Patent Grant Mailed | 28 Jun, 2022 | US11369566 |
| Email Notification | 09 Jun, 2022 | US11369566 |
| Issue Notification Mailed | 08 Jun, 2022 | US11369566 |
| Dispatch to FDC | 31 May, 2022 | US11369566 |
| Mail Response to 312 Amendment (PTO-271) | 31 May, 2022 | US11369566 |
FDA has granted several exclusivities to Otiprio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Otiprio, 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 Otiprio.
Exclusivity Information
Otiprio holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Otiprio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 10, 2018 |
| New Indication(I-770) | Mar 02, 2021 |
US patents provide insights into the exclusivity only within the United States, but Otiprio 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 Otiprio's family patents as well as insights into ongoing legal events on those patents.
Otiprio's family patents
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Generic Launch
Generic Release Date:
Otiprio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 27, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Otiprio Generics:
Ciprofloxacin is the generic name for the brand Otiprio. 11 different companies have already filed for the generic of Otiprio, with Hikma Farmaceutica having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Otiprio's generic
About Otiprio
Otiprio is a drug owned by Alk-Abello Inc. It is used for treating ear infections and inflammation in both pediatric and adult patients. Otiprio uses Ciprofloxacin as an active ingredient. Otiprio was launched by Alk Abello in 2015.
Market Authorisation Date:
Otiprio was approved by FDA for market use on 10 December, 2015.
Active Ingredient:
Otiprio uses Ciprofloxacin as the active ingredient. Check out other Drugs and Companies using Ciprofloxacin ingredient
Treatment:
Otiprio is used for treating ear infections and inflammation in both pediatric and adult patients.
Dosage:
Otiprio is available in injectable, suspension form for otic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6% (60MG/ML) | INJECTABLE, SUSPENSION | Discontinued | OTIC |