LATANOPROST; NETARSUDIL DIMESYLATE - Generic Drug Details

What are the generic sources for latanoprost; netarsudil dimesylate and what is the scope of patent protection?

Latanoprost; netarsudil dimesylate is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprost; netarsudil dimesylate has sixty-eight patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for LATANOPROST; NETARSUDIL DIMESYLATE

International Patents:	68
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATANOPROST; NETARSUDIL DIMESYLATE
DailyMed Link:	LATANOPROST; NETARSUDIL DIMESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LATANOPROST; NETARSUDIL DIMESYLATE

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 LATANOPROST; NETARSUDIL DIMESYLATE

Drug Class	Prostaglandin Analog Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Paragraph IV (Patent) Challenges for LATANOPROST; NETARSUDIL DIMESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ROCKLATAN	Ophthalmic Solution	latanoprost; netarsudil dimesylate	0.005%/0.02%	208259	2	2021-12-20

US Patents and Regulatory Information for LATANOPROST; NETARSUDIL DIMESYLATE

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	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes

International Patents for LATANOPROST; NETARSUDIL DIMESYLATE

Country	Patent Number	Title	Estimated Expiration
Canada	2905089	COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES)
Denmark	3811943
Hong Kong	1258617	雙重機制抑制劑用於治療疾病 (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE)
Portugal	3811943
Spain	2474150

Supplementary Protection Certificates for LATANOPROST; NETARSUDIL DIMESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	97C0128	France		PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
3461484	122021000036	Germany		PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
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	SPC/GB20/019	United Kingdom		PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 20191121
3053913	2020/016	Ireland		PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121