Nepafenac - Generic Drug Details
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What are the generic drug sources for nepafenac and what is the scope of freedom to operate?
Nepafenac
is the generic ingredient in two branded drugs marketed by Harrow Eye and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Nepafenac has one hundred and twenty-one patent family members in twenty-eight countries.
There are eight drug master file entries for nepafenac. Two suppliers are listed for this compound.
Summary for nepafenac
| International Patents: | 121 |
| US Patents: | 6 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 45 |
| Patent Applications: | 3,811 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nepafenac |
| What excipients (inactive ingredients) are in nepafenac? | nepafenac excipients list |
| DailyMed Link: | nepafenac at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nepafenac
*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 nepafenac
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kafrelsheikh University | Phase 4 |
| Vistar Eye Center | N/A |
| Virginia Polytechnic Institute and State University | N/A |
Pharmacology for nepafenac
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for nepafenac
US Patents and Regulatory Information for nepafenac
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 nepafenac
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for nepafenac
| 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 nepafenac
Supplementary Protection Certificates for nepafenac
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0999825 | 92301 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE |
| 0999825 | CA 2013 00055 | Denmark | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 |
| 0999825 | C300622 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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