Ilevro is a drug owned by Harrow Eye Llc. It is protected by 5 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 31, 2032. Details of Ilevro'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). | |||
| US8921337 | Carboxyvinyl polymer-containing nanoparticle suspensions |
Mar, 2032
(7 years from now) | Active |
| US9662398 | Carboxylvinyl polymer-containing nanoparticle suspensions |
Dec, 2030
(6 years from now) | Active |
| US7947295 | Ophthalmic compositions containing a synergistic combination of two polymers |
Jun, 2024
(5 months ago) |
Expired
|
| US6403609 | Ophthalmic compositions containing galactomannan polymers and borate |
Jul, 2018
(6 years ago) |
Expired
|
| US5475034 | Topically administrable compositions containing 3-benzoylphenylacetic acid derivatives for treatment of ophthalmic inflammatory disorders |
Jun, 2014
(10 years ago) |
Expired
|
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 Ilevro's patents.
Latest Legal Activities on Ilevro's Patents
Given below is the list of recent legal activities going on the following patents of Ilevro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jun, 2024 | US9662398 |
| Email Notification Critical | 07 Mar, 2023 | US9662398 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Mar, 2023 | US9662398 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Mar, 2023 | US7947295 (Litigated) |
| Email Notification Critical | 07 Mar, 2023 | US7947295 (Litigated) |
| Correspondence Address Change Critical | 01 Mar, 2023 | US7947295 (Litigated) |
| Correspondence Address Change Critical | 01 Mar, 2023 | US9662398 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Nov, 2022 | US7947295 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Nov, 2020 | US9662398 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2018 | US7947295 (Litigated) |
FDA has granted several exclusivities to Ilevro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ilevro, 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 Ilevro.
Exclusivity Information
Ilevro holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Ilevro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 16, 2015 |
Several oppositions have been filed on Ilevro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ilevro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ilevro patents.
Ilevro's Oppositions Filed in EPO
Ilevro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 04, 2017, by Reckitt Benckiser (Brands) Limited. This opposition was filed on patent number EP12173896A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12173896A | Jan, 2017 | Reckitt Benckiser (Brands) Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Ilevro 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 Ilevro's family patents as well as insights into ongoing legal events on those patents.
Ilevro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ilevro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 31, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ilevro Generics:
There are no approved generic versions for Ilevro as of now.
How can I launch a generic of Ilevro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ilevro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ilevro's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ilevro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.003 | 21 Dec, 2015 | 1 | 31 Mar, 2032 |
Alternative Brands for Ilevro
Ilevro which is used for treating ocular inflammation., has several other brand drugs in the same treatment category and using the same active ingredient (Nepafenac). 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 | ||
|---|---|---|---|---|
| Harrow Eye |
| |||
About Ilevro
Ilevro is a drug owned by Harrow Eye Llc. It is used for treating ocular inflammation. Ilevro uses Nepafenac as an active ingredient. Ilevro was launched by Harrow Eye in 2012.
Approval Date:
Ilevro was approved by FDA for market use on 16 October, 2012.
Active Ingredient:
Ilevro uses Nepafenac as the active ingredient. Check out other Drugs and Companies using Nepafenac ingredient
Treatment:
Ilevro is used for treating ocular inflammation.
Dosage:
Ilevro is available in suspension/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3% | SUSPENSION/DROPS | Prescription | OPHTHALMIC |