Qlosi is a drug owned by Orasis Pharmaceuticals Ltd. It is protected by 4 US drug patents filed from 2023 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 18, 2037. Details of Qlosi'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). | |||
| US10639297 | Ophthalmic pharmaceutical compositions and uses relating thereto |
Aug, 2037
(12 years from now) | Active |
| US9867810 | Ophthalmic pharmaceutical compositions and uses relating thereto |
Aug, 2037
(12 years from now) | Active |
| US11129812 | Ophthalmic pharmaceutical compositions and uses relating thereto |
Aug, 2037
(12 years from now) | Active |
| US11974986 | Ophthalmic pharmaceutical compositions and uses relating thereto |
Aug, 2037
(12 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 Qlosi's patents.
Latest Legal Activities on Qlosi's Patents
Given below is the list of recent legal activities going on the following patents of Qlosi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 25 Oct, 2023 | US10639297 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Sep, 2021 | US11129812 |
| Recordation of Patent Grant Mailed Critical | 28 Sep, 2021 | US11129812 |
| Email Notification Critical | 09 Sep, 2021 | US11129812 |
| Issue Notification Mailed Critical | 08 Sep, 2021 | US11129812 |
| Application Is Considered Ready for Issue Critical | 25 Aug, 2021 | US11129812 |
| Dispatch to FDC | 25 Aug, 2021 | US11129812 |
| Mail Response to 312 Amendment (PTO-271) Critical | 24 Aug, 2021 | US11129812 |
| Email Notification Critical | 24 Aug, 2021 | US11129812 |
| Response to Amendment under Rule 312 Critical | 19 Aug, 2021 | US11129812 |
FDA has granted several exclusivities to Qlosi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qlosi, 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 Qlosi.
Exclusivity Information
Qlosi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Qlosi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 17, 2026 |
US patents provide insights into the exclusivity only within the United States, but Qlosi 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 Qlosi's family patents as well as insights into ongoing legal events on those patents.
Qlosi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qlosi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 18, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qlosi Generic API suppliers:
Pilocarpine Hydrochloride is the generic name for the brand Qlosi. 8 different companies have already filed for the generic of Qlosi, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Qlosi's generic
Alternative Brands for Qlosi
Qlosi which is used for correcting age-related loss of near vision (presbyopia)., has several other brand drugs using the same active ingredient (Pilocarpine Hydrochloride). 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 | |
|---|---|---|
| Abbvie |
| |
| Alcon |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pilocarpine Hydrochloride, Qlosi's active ingredient. Check the complete list of approved generic manufacturers for Qlosi
About Qlosi
Qlosi is a drug owned by Orasis Pharmaceuticals Ltd. It is used for correcting age-related loss of near vision (presbyopia). Qlosi uses Pilocarpine Hydrochloride as an active ingredient. Qlosi was launched by Orasis Pharms in 2023.
Approval Date:
Qlosi was approved by FDA for market use on 17 October, 2023.
Active Ingredient:
Qlosi uses Pilocarpine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Pilocarpine Hydrochloride ingredient
Treatment:
Qlosi is used for correcting age-related loss of near vision (presbyopia).
Dosage:
Qlosi is available in solution form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4% | SOLUTION | Prescription | OPHTHALMIC |