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Last Updated: April 25, 2024

Netarsudil mesylate - Generic Drug Details


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What are the generic sources for netarsudil mesylate and what is the scope of freedom to operate?

Netarsudil mesylate is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Netarsudil mesylate has sixty-eight patent family members in fourteen countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for netarsudil mesylate
Generic Entry Date for netarsudil mesylate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/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.

Pharmacology for netarsudil mesylate
Drug ClassRho Kinase Inhibitor
Mechanism of ActionRho Kinase Inhibitors
Paragraph IV (Patent) Challenges for NETARSUDIL MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RHOPRESSA Ophthalmic Solution netarsudil mesylate 0.02% 208254 2 2021-12-20

US Patents and Regulatory Information for netarsudil mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

International Patents for netarsudil mesylate

Country Patent Number Title Estimated Expiration
Japan 2020125355 併用療法 (COMBINATION THERAPY) ⤷  Try a Trial
Canada 2929545 INHIBITEURS A MECANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2010011853 ⤷  Try a Trial
Japan 2023030072 併用療法 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2010126626 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for netarsudil mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3461484 21C1024 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3053913 2020/016 Ireland ⤷  Try a Trial PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3053913 132020000000043 Italy ⤷  Try a Trial PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121
3461484 132021000000068 Italy ⤷  Try a Trial PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3053913 C202030018 Spain ⤷  Try a Trial PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREOMERO, SAL O SOLVATO DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1400; DATE OF AUTHORISATION: 20191119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1400; DATE OF FIRST AUTHORISATION IN EEA: 20191119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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