Omlonti is a drug owned by Ocuvex Therapeutics Inc. It is protected by 11 US drug patents filed from 2022 to 2023 out of which none have expired yet. Omlonti's patents will be open to challenges from 22 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 16, 2039. Details of Omlonti's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10774072 | Crystal of N-substituted sulfonamide compound |
Jun, 2035
(10 years from now) | Active |
| US8648097 | Pyridylaminoacetic acid compound |
Oct, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11666563 | Pharmaceutical preparation containing pyridyl aminoacetic acid compound |
Jul, 2039
(14 years from now) | Active |
| USRE48183 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US9415038 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US11793798 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US10765750 | Pharmaceutical composition containing pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US11197849 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US10702511 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US10179127 | Pharmaceutical formulations comprising a pyridylaminoacetic acid compound |
Jan, 2035
(9 years from now) | Active |
| US8685986 | Medical composition for treatment or prophylaxis of glaucoma |
Oct, 2029
(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 Omlonti's patents.
Latest Legal Activities on Omlonti's Patents
Given below is the list of recent legal activities going on the following patents of Omlonti.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Paralegal Petition Decision | 27 Jun, 2024 | US8685986 |
| Paralegal Petition Decision | 27 Jun, 2024 | US10702511 |
| Petition Entered | 22 May, 2024 | US8685986 |
| Second letter to regulating agency to determine regulatory review period | 07 May, 2024 | US8685986 |
| Second letter to regulating agency to determine regulatory review period | 07 May, 2024 | US10702511 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Feb, 2024 | US10774072 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Feb, 2024 | US10765750 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Jan, 2024 | US9415038 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10702511 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8685986 |
FDA has granted several exclusivities to Omlonti. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Omlonti, 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 Omlonti.
Exclusivity Information
Omlonti holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Omlonti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 22, 2027 |
US patents provide insights into the exclusivity only within the United States, but Omlonti 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 Omlonti's family patents as well as insights into ongoing legal events on those patents.
Omlonti's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Omlonti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 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)
Omlonti Generics:
There are no approved generic versions for Omlonti as of now.
About Omlonti
Omlonti is a drug owned by Ocuvex Therapeutics Inc. It is used for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Omlonti uses Omidenepag Isopropyl as an active ingredient. Omlonti was launched by Ocuvex Therap in 2022.
Approval Date:
Omlonti was approved by FDA for market use on 22 September, 2022.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Omlonti is 22 September, 2022, its NCE-1 date is estimated to be 22 September, 2026.
Active Ingredient:
Omlonti uses Omidenepag Isopropyl as the active ingredient. Check out other Drugs and Companies using Omidenepag Isopropyl ingredient
Treatment:
Omlonti is used for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage:
Omlonti is available in solution form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.002% | SOLUTION | Discontinued | OPHTHALMIC |