ILEVRO Drug Patent Profile
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Which patents cover Ilevro, and what generic alternatives are available?
Ilevro is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-four patent family members in twenty-six countries.
The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.
DrugPatentWatch® Generic Entry Outlook for Ilevro
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 8, 2024. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ILEVRO
International Patents: | 94 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 5 |
Patent Applications: | 2,523 |
Drug Prices: | Drug price information for ILEVRO |
Drug Sales Revenues: | Drug sales revenues for ILEVRO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ILEVRO |
What excipients (inactive ingredients) are in ILEVRO? | ILEVRO excipients list |
DailyMed Link: | ILEVRO at DailyMed |



DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ILEVRO
Generic Entry Date for ILEVRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ILEVRO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vance Thompson Vision - MT | Phase 4 |
MDbackline, LLC | N/A |
Alcon Research | N/A |
Pharmacology for ILEVRO
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ILEVRO
US Patents and Regulatory Information for ILEVRO
ILEVRO is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ILEVRO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ILEVRO
Ophthalmic compositions containing a synergistic combination of two polymers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Carboxyvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Carboxylvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ILEVRO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ILEVRO
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Nevanac | nepafenac | EMEA/H/C/000818 Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., , |
Authorised | no | no | no | 2007-12-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ILEVRO
See the table below for patents covering ILEVRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2506831 | SUSPENSION DE NANOPARTICULES CONTENANT UN POLYMÈRE DE TYPE CARBOXYVINYLE (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSIONS) | ⤷ Try a Trial |
Canada | 2839847 | COMPOSITIONS OPHTALMOLOGIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS) | ⤷ Try a Trial |
Japan | 2011026354 | OPHTHALMIC COMPOSITION CONTAINING SYNERGISTIC COMBINATION OF TWO POLYMERS | ⤷ Try a Trial |
Japan | 2013512912 | ⤷ Try a Trial | |
Poland | 2116227 | ⤷ Try a Trial | |
Spain | 2302881 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ILEVRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0999825 | 92301 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE |
0999825 | CA 2013 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503 |
0716600 | C00716600/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 |
0999825 | C300622 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 |
0999825 | 122013000085 | Germany | ⤷ Try a Trial | PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |