RHOPRESSA Drug Patent Profile

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

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

See drug prices for RHOPRESSA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for RHOPRESSA

NDA:

208254

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

Sponsor	Phase
Salus University	Phase 4
Price Vision Group	Phase 2/Phase 3
Cornea Research Foundation of America	Phase 2/Phase 3

See all RHOPRESSA clinical trials

Pharmacology for RHOPRESSA

Drug Class	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RHOPRESSA

S01EX	Other antiglaucoma preparations
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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.

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

FDA Regulatory Exclusivity protecting RHOPRESSA

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			Y	Y
Aerie Pharms Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes
Aerie Pharms Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes
Aerie Pharms Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes				Y

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

Canada

China

European Patent Office

Japan

Netherlands

Spain

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)
Spain	2852377
Australia	2017248440	DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE
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)

Supplementary Protection Certificates for RHOPRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	2020/016	Ireland		PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3053913	2020C/510	Belgium		PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3461484	21C1024	France		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		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