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Last Updated: January 28, 2023

RHOPRESSA Drug Patent Profile


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When do Rhopressa patents expire, and what generic alternatives are available?

Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in nine countries.

The generic ingredient in RHOPRESSA is netarsudil mesylate. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.

DrugPatentWatch® Generic Entry Outlook for Rhopressa

Rhopressa was eligible for patent challenges on December 18, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for RHOPRESSA
International Patents:59
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 4
Patent Applications: 162
Drug Prices: Drug price information for RHOPRESSA
What excipients (inactive ingredients) are in RHOPRESSA?RHOPRESSA excipients list
DailyMed Link:RHOPRESSA at DailyMed
Drug patent expirations by year for RHOPRESSA
Drug Prices for RHOPRESSA

See drug prices for RHOPRESSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for RHOPRESSA
Generic Entry Date for RHOPRESSA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for RHOPRESSA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Salus UniversityPhase 4
Price Vision GroupPhase 2/Phase 3
Cornea Research Foundation of AmericaPhase 2/Phase 3

See all RHOPRESSA clinical trials

Pharmacology for RHOPRESSA
Drug ClassRho Kinase Inhibitor
Mechanism of Action Rho Kinase Inhibitors
Paragraph IV (Patent) Challenges for RHOPRESSA
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 RHOPRESSA

RHOPRESSA is protected by thirteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RHOPRESSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 RHOPRESSA

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Compositions for treating glaucoma or reducing intraocular pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

FDA Regulatory Exclusivity protecting RHOPRESSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aerie Pharms Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aerie Pharms Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aerie Pharms Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aerie Pharms Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 RHOPRESSA

When does loss-of-exclusivity occur for RHOPRESSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14228790
Estimated Expiration: See Plans and Pricing

Patent: 18202965
Estimated Expiration: See Plans and Pricing

Patent: 18202990
Estimated Expiration: See Plans and Pricing

Patent: 20203976
Estimated Expiration: See Plans and Pricing

Canada

Patent: 05089
Estimated Expiration: See Plans and Pricing

China

Patent: 5263494
Estimated Expiration: See Plans and Pricing

Patent: 9528721
Estimated Expiration: See Plans and Pricing

Patent: 0396085
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 76080
Estimated Expiration: See Plans and Pricing

Patent: 61484
Estimated Expiration: See Plans and Pricing

Patent: 11943
Estimated Expiration: See Plans and Pricing

Japan

Patent: 16515520
Estimated Expiration: See Plans and Pricing

Patent: 19094339
Estimated Expiration: See Plans and Pricing

Patent: 20125355
Estimated Expiration: See Plans and Pricing

Patent: 20143163
Estimated Expiration: See Plans and Pricing

Patent: 21046439
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1101
Estimated Expiration: See Plans and Pricing

Spain

Patent: 76199
Estimated Expiration: See Plans and Pricing

Patent: 52377
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RHOPRESSA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3053913 INHIBITEURS À DOUBLE MÉCANISME POUR LE TRAITEMENT D'UNE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) See Plans and Pricing
Spain 2852377 See Plans and Pricing
Australia 2017248440 DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE See Plans and Pricing
European Patent Office 2326623 COMPOSÉS AMIDÉS BÉTA ET GAMMA-AMINO ISOQUINOLINE ET COMPOSÉS BENZAMIDE SUBSTITUÉ (BETA-AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUNDS AND SUBSTITUTED BENZAMIDE COMPOUNDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RHOPRESSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3053913 2020/016 Ireland See Plans and Pricing PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3053913 2020C/510 Belgium See Plans and Pricing PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3461484 21C1024 France See Plans and Pricing PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3053913 C202030018 Spain See Plans and Pricing 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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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.