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Last Updated: April 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 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.

Summary for netarsudil mesylate

International Patents:	68
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	39
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for netarsudil mesylate
DailyMed Link:	netarsudil mesylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for netarsudil mesylate

Generic Entry Date for netarsudil mesylate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 Class	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for netarsudil mesylate

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

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

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Glossary

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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	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	Y			⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Australia	2016201754	Dual mechanism inhibitors for the treatment of disease	⤷ Try a Trial
Australia	2017248440	DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE	⤷ Try a Trial
Spain	2474150		⤷ Try a Trial
European Patent Office	2424842	INHIBITEURS À MÉCANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for netarsudil mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	2020C/510	Belgium	⤷ Try a Trial	PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
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	SPC/GB21/033	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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