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ROCKLATAN Drug Patent Profile

Which patents cover Rocklatan, and when can generic versions of Rocklatan launch?

Rocklatan is a drug marketed by Alcon Labs Inc and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in fourteen countries.

The generic ingredient in ROCKLATAN is latanoprost; netarsudil dimesylate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the latanoprost; netarsudil dimesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Rocklatan

Rocklatan 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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ROCKLATAN

International Patents:	68
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for ROCKLATAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROCKLATAN
What excipients (inactive ingredients) are in ROCKLATAN?	ROCKLATAN excipients list
DailyMed Link:	ROCKLATAN at DailyMed

See drug prices for ROCKLATAN

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

Constraining patent/regulatory exclusivity:

9,415,043

NDA:

208259

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 ROCKLATAN

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

Sponsor	Phase
Aerie Pharmaceuticals	Phase 4

See all ROCKLATAN clinical trials

Pharmacology for ROCKLATAN

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

Paragraph IV (Patent) Challenges for ROCKLATAN

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 ROCKLATAN

ROCKLATAN is protected by seventeen US patents.

This potential generic entry date is based on patent 9,415,043.

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

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	9,993,470		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,532,993
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	9,096,569		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,654,844		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,588,901		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	11,197,853		Y

International Patents for ROCKLATAN

When does loss-of-exclusivity occur for ROCKLATAN?

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

Australia

Canada

China

Denmark

European Patent Office

Finland

Hungary

Japan

Netherlands

Poland

Portugal

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 ROCKLATAN around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1258617
European Patent Office	2424842	INHIBITEURS À MÉCANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE)
Australia	2017248440
Japan	2020143163	併用療法 (COMBINATION THERAPY)
Denmark	3811943
Canada	2905089	COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES)

Supplementary Protection Certificates for ROCKLATAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	SPC/GB20/019	United Kingdom		PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 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	2020C/510	Belgium		PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3461484	C202130024	Spain		PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107
3053913	132020000000043	Italy		PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121
0364417	97C0128	France		PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718

ROCKLATAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ROCKLATAN

Introduction to ROCKLATAN

ROCKLATAN, a groundbreaking ophthalmic solution, is a fixed-dose combination of netarsudil and latanoprost, designed to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This dual-action mechanism sets it apart as a significant advancement in ocular health[4].

Market Potential and Competitive Landscape

ROCKLATAN enters a glaucoma market valued at approximately $3 billion, with latanoprost previously holding about 41% of the market share. The drug's unique combination of a Rho kinase inhibitor (netarsudil) and a prostaglandin F2α analog (latanoprost) positions it as the first and only fixed-dose combination product in the U.S. that includes a prostaglandin for IOP reduction, requiring only once-daily dosing[1][4].

Clinical and Commercial Developments

Clinical Efficacy

ROCKLATAN has demonstrated superior efficacy compared to latanoprost alone in Phase 3 studies. This clinical superiority is a key factor driving its market potential and adoption among healthcare professionals[1].

Commercial Performance

Since its FDA approval in 2019, ROCKLATAN has shown strong commercial performance. Aerie Pharmaceuticals reported significant revenue growth from its glaucoma franchise, which includes both ROCKLATAN and Rhopressa. In the fourth quarter of 2020, net revenues from these products reached $24.7 million, with shipments to wholesalers increasing by 18% compared to the previous quarter[3].

Market Access and Coverage

ROCKLATAN has secured substantial market access, including commercial coverage for 89% of covered lives and market access for 56% of Medicare Part D lives, with an additional 15% of remaining Medicare Part D lives under review. This broad coverage is crucial for its market penetration and patient accessibility[3].

Pricing Strategy

Aerie Pharmaceuticals priced ROCKLATAN at a small premium to Rhopressa, between $110 to $115 per bottle on a net basis. This pricing strategy, while slightly higher than Rhopressa, is expected to be competitive given the drug's enhanced efficacy and convenience of once-daily dosing[1].

Financial Projections and Performance

Revenue Growth

Aerie Pharmaceuticals has seen a steady increase in net revenues from its glaucoma franchise. For the year ended December 31, 2020, net revenues totaled $83.1 million, reflecting a 19% increase from the previous year. The company expects this trend to continue, driven by strong sequential volume growth and increased net revenue per bottle[3].

Peak Sales Estimates

Analysts project peak sales of ROCKLATAN to reach around $647 million by 2025, although some estimates suggest it could be as high as $735 million. These projections underscore the drug's significant market potential and its role as a key product in Aerie's pipeline[1].

Operational and Financial Highlights

Cost Optimization and Revenue Growth

Aerie has implemented cost optimization strategies, including reducing fees paid to wholesalers and refining payer rebate contracts. These efforts have contributed to increased net revenue per bottle and are expected to continue driving financial performance[3].

Collaboration and Expansion

The company's collaboration with Santen Pharmaceutical has also been beneficial, with the first Phase 3 trial for Rhopressa underway in Japan. This international expansion and collaborative approach are likely to further enhance ROCKLATAN's market reach and financial trajectory[3].

Competitive Analysis

ROCKLATAN's unique dual-action mechanism and once-daily dosing regimen set it apart from other treatments in the glaucoma market. The report by DelveInsight highlights that ROCKLATAN's market forecast will be crucial in understanding its positioning and potential market share among emerging therapies for glaucoma[4].

Future Market Assessments

The comprehensive market report for ROCKLATAN includes forecasted sales evaluations until 2032, providing valuable insights into the drug's clinical trial progress, regulatory and commercial aspects, and its impact on the competitive environment. This analysis will aid in strategic planning and decision-making within the therapeutic domain[4].

Key Takeaways

• Market Potential: ROCKLATAN enters a $3 billion glaucoma market with a unique dual-action mechanism.
• Clinical Efficacy: Superior to latanoprost alone in Phase 3 studies.
• Commercial Performance: Strong revenue growth and market access.
• Pricing Strategy: Priced at a small premium to Rhopressa.
• Financial Projections: Peak sales estimated at $647 million by 2025.
• Operational Efficiency: Cost optimization and revenue growth through refined contracts and collaborations.

FAQs

Q: What is ROCKLATAN and how does it work?

ROCKLATAN is a fixed-dose combination of netarsudil and latanoprost, designed to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It works by combining the efficacy of a Rho kinase inhibitor with a prostaglandin F2α analog.

Q: What is the market size for glaucoma treatments that ROCKLATAN is entering?

The glaucoma market is valued at approximately $3 billion, with latanoprost previously holding about 41% of the market share.

Q: How has ROCKLATAN performed commercially since its approval?

ROCKLATAN has shown strong commercial performance, with net revenues from Aerie's glaucoma franchise increasing by 19% in 2020 compared to the previous year.

Q: What is the pricing strategy for ROCKLATAN?

ROCKLATAN is priced at a small premium to Rhopressa, between $110 to $115 per bottle on a net basis.

Q: What are the peak sales estimates for ROCKLATAN?

Analysts project peak sales of ROCKLATAN to reach around $647 million by 2025, although some estimates suggest it could be as high as $735 million.

Sources

1. BioPharma Dive: Aerie's eye drops win FDA approval - BioPharma Dive
2. Santen Pharmaceutical: Q2 FY2023 Financial Results - Santen Pharmaceutical
3. Aerie Pharmaceuticals: Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update 2021
4. DelveInsight: Rocklatan (Netarsudil and Latanoprost Ophthalmic Solution) for Glaucoma Market Size and Share Analysis and Competitive Landscape
5. Santen Pharmaceutical: Q1 FY2023 Financial Results - Santen Pharmaceutical