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Last Updated: March 28, 2024

NETARSUDIL MESYLATE - Generic Drug Details


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What are the generic drug sources for netarsudil mesylate and what is the scope of patent protection?

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-seven 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 ⤷  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 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 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
World Intellectual Property Organization (WIPO) 2014144781 ⤷  Try a Trial
Japan 2012525442 ⤷  Try a Trial
Spain 2852377 ⤷  Try a Trial
Spain 2834451 ⤷  Try a Trial
Portugal 3811943 ⤷  Try a Trial
Japan 2014208681 ベータおよびガンマ−アミノ−イソキノリンアミド化合物および置換ベンズアミド化合物 (BETA- AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUND AND SUBSTITUTED BENZAMIDE COMPOUND) ⤷  Try a Trial
Hong Kong 1258617 雙重機制抑制劑用於治療疾病 (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) ⤷  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
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
3053913 2020C/510 Belgium ⤷  Try a Trial PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3053913 122020000016 Germany ⤷  Try a Trial PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119
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
3461484 301101 Netherlands ⤷  Try a Trial PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3053913 20C1017 France ⤷  Try a Trial PRODUCT NAME: NETARSUDIL, OU ENANTIOMERE, DIASTEREOMERE, SEL OU SOLVATE DE CELUI-CI; 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
>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.