Upneeq is a drug owned by Rvl Pharmaceuticals Inc. It is protected by 14 US drug patents filed from 2020 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 16, 2039. Details of Upneeq'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). | |||
| US11324722 | Compositions and methods for treating ocular disorders |
Dec, 2039
(13 years from now) | Active |
| US11103482 | Oxymetazoline compositions |
Dec, 2039
(13 years from now) | Active |
| US12605363 | Oxymetazoline Compositions |
Dec, 2039
(13 years from now) | Active |
| US12648930 | Compositions And Methods For Treating Ocular Disorders |
Dec, 2039
(13 years from now) | Active |
| US10898573 | Oxymetazoline compositions |
Dec, 2039
(13 years from now) | Active |
| US11701343 | Compositions and methods for treating ocular disorders |
Dec, 2039
(13 years from now) | Active |
| US10799481 | Compositions and methods for treating ocular disorders |
Dec, 2039
(13 years from now) | Active |
| US10940138 | Compositions and methods for treating ocular disorders |
Dec, 2039
(13 years from now) | Active |
| US10814001 | Oxymetazoline compositions |
Dec, 2039
(13 years from now) | Active |
| US11311515 | Oxymetazoline compositions |
Dec, 2039
(13 years from now) | Active |
| US11541036 | Oxymetazoline compositions |
Dec, 2039
(13 years from now) | Active |
| US8357714 | Compositions and methods for non-surgical treatment of ptosis |
Aug, 2031
(4 years from now) | Active |
| US9867808 | Compositions and methods for non-surgical treatment of Ptosis |
Aug, 2031
(4 years from now) | Active |
| US10912765 | Compositions and methods for non-surgical treatment of ptosis |
Aug, 2031
(4 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 Upneeq's patents.
Latest Legal Activities on Upneeq's Patents
Given below is the list of recent legal activities going on the following patents of Upneeq.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 Nov, 2025 | US11324722 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 22 Oct, 2025 | US11311515 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 13 Jul, 2025 | US9867808 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 30 Jan, 2025 | US11103482 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 09 Sep, 2024 | US10940138 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 07 Aug, 2024 | US10912765 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 24 Jul, 2024 | US10898573 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 17 Jul, 2024 | US8357714 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 12 Apr, 2024 | US10814001 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 12 Apr, 2024 | US10799481 |
FDA has granted several exclusivities to Upneeq. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Upneeq, 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
Upneeq.
Exclusivity Information
Upneeq holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Upneeq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 08, 2023 |
US patents provide insights into the exclusivity only within the United States, but
Upneeq 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 Upneeq's family patents as well as insights into
ongoing legal events
on those patents.
Upneeq's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Upneeq:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
| ||||
| A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults | Bayer | NA | COMPLETED
(Jun 1, 2026) | PHASE2 |
| LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. | Santen SAS | NA | RECRUITING
(Apr 1, 2026) | PHASE3 |
Generic Launch
Generic Release Date:
Upneeq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 16, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Upneeq Generic API suppliers:
Oxymetazoline Hydrochloride is the generic name for the brand Upneeq. 1 company has already filed for the generic of Upneeq. Check out the entire list of companies who have already received approval for Upneeq's generic
Alternative Brands for Upneeq
Upneeq which is used for correcting drooping eyelids., has several other brand drugs using the same active ingredient (Oxymetazoline 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxymetazoline Hydrochloride, Upneeq's active ingredient. Check the complete list of approved generic manufacturers for Upneeq
About Upneeq
Upneeq is a drug owned by Rvl Pharmaceuticals Inc. It is used for correcting drooping eyelids. Upneeq uses Oxymetazoline Hydrochloride as an active ingredient. Upneeq was launched by Rvl in 2020.
Approval Date:
Upneeq was approved by FDA for market use on 08 July, 2020.
Active Ingredient:
Upneeq uses Oxymetazoline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxymetazoline Hydrochloride ingredient
Treatment:
Upneeq is used for correcting drooping eyelids.
Dosage:
Upneeq is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1% | SOLUTION/DROPS | Prescription | OPHTHALMIC |
