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 seventeen 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:	17
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	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LATANOPROST; NETARSUDIL DIMESYLATE

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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	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
Australia	2017248440
China	109528721	联合治疗 (Combination therapy)
China	110396085	联合治疗 (Combination therapy)
European Patent Office	3828172	INHIBITEURS À DOUBLE MECANISME POUR LE TRAITEMENT D'UNE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE)
Spain	2834451

Supplementary Protection Certificates for LATANOPROST; NETARSUDIL DIMESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	132020000000043	Italy		PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121
3461484	132021000000068	Italy		PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3053913	2020/016	Ireland		PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
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
3461484	SPC/GB21/033	United Kingdom		PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107

Market Dynamics and Financial Trajectory for Latanoprost and Netarsudil Dimesylate

Introduction to Latanoprost and Netarsudil Dimesylate

Latanoprost and Netarsudil Dimesylate are key components in the treatment of glaucoma and ocular hypertension. Latanoprost is a prostaglandin analog, while Netarsudil Dimesylate is a rho kinase inhibitor. When combined, they form a potent fixed-dose combination (FDC) that has shown significant efficacy in reducing intraocular pressure (IOP).

Global Market Size and Growth

The global market for Latanoprost is substantial and growing. As of 2024, the global Latanoprost market size is estimated to be USD 1521.2 million, with a projected compound annual growth rate (CAGR) of 2.5% from 2024 to 2031[4].

Regional Market Breakdown

• North America: This region accounts for more than 40% of the global revenue, with a market size of USD 608.48 million in 2024. The CAGR for North America is expected to be 0.7% from 2024 to 2031. The brand drug segment dominates this market, but generic alternatives are expected to enter as patents expire[4].
• Europe: Europe accounts for over 30% of the global market, with a market value of USD 456.36 million in 2024. The CAGR for Europe is projected to be 1.0% from 2024 to 2031. Europe's well-established healthcare systems and stringent regulatory frameworks are key factors in this market[4].
• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 349.88 million in 2024. The CAGR for Asia Pacific is expected to be 4.5% from 2024 to 2031, driven by a large and diverse population and an increasing prevalence of glaucoma and ocular hypertension[4].

Efficacy and Safety of the Fixed-Dose Combination

The fixed-dose combination of Netarsudil 0.02%/Latanoprost 0.005% ophthalmic solution (NET/LAT) has demonstrated consistent IOP reduction. In Phase 3 trials, this combination showed an average reduction from baseline IOPs of approximately 37%, with a reduction of approximately 9.5 millimeters of mercury (mmHg) throughout the day[1].

Financial Performance of Key Players

Santen Pharmaceutical

Santen Pharmaceutical, a major player in the ophthalmic drug market, has shown significant financial growth. In Q1 FY2023, Santen reported a revenue increase of 10.5% year-over-year, driven by strong sales across all regions, including a recovery in the China market post-COVID-19. The company's core operating profit increased by 46.6% year-over-year, attributed to cost optimization and strong sales of mainstay products such as Tapros and Diquas[2].

• Revenue Growth: Revenue increased by 3.3% year-over-year to ¥249.6 billion in the fiscal year ended March 31, 2021, despite the impact of the COVID-19 outbreak[3].
• Operating Profit: Core operating profit on a core basis increased by 0.2% year-over-year to ¥50.1 billion in the fiscal year ended March 31, 2021[3].
• Regional Performance: Strong growth was observed in Japan, China, and Asia, with significant contributions from mainstay prescription pharmaceuticals[3].

Market Drivers and Challenges

Drivers

• Aging Population: The increasing aging population globally is a significant driver for the Latanoprost market, as older adults are more prone to glaucoma and ocular hypertension[4].
• Healthcare Advancements: Advanced healthcare infrastructure and early diagnosis and treatment capabilities in regions like North America and Europe contribute to market growth[4].
• Combination Therapy: The efficacy of the fixed-dose combination of Netarsudil and Latanoprost enhances patient compliance and treatment outcomes, driving market demand[1].

Challenges

• Patent Expirations: The eventual expiration of patents for brand-name drugs like Latanoprost leads to the entry of generic alternatives, which can reduce market share and revenue for brand-name products[4].
• Regulatory Scrutiny: Generic versions of Latanoprost must undergo rigorous regulatory scrutiny to ensure bioequivalence, safety, and efficacy, which can be a challenge for market entry[4].
• Regional Variations: The diverse and dynamic nature of the Asia Pacific market, for example, presents unique challenges and opportunities that require a thorough understanding of local healthcare systems and regulatory environments[4].

Competitive Landscape

The ophthalmic drug market is competitive, with several players vying for market share. The combination of Netarsudil and Latanoprost offers a competitive edge due to its proven efficacy and patient compliance benefits.

Key Competitors

• Santen Pharmaceutical: As mentioned, Santen is a significant player with a strong portfolio of ophthalmic drugs, including Tapros and Diquas[2][3].
• Other Pharmaceutical Companies: Companies like Bayer Yakuhin, Ltd., and Eyevance Pharmaceuticals Holdings Inc. also play important roles in the market, often through co-promotion agreements and strategic acquisitions[3].

Future Outlook

The future outlook for Latanoprost and the fixed-dose combination with Netarsudil Dimesylate is promising. Here are some key points:

• Market Expansion: The Asia Pacific region, in particular, offers immense growth potential due to its large and diverse population and increasing prevalence of glaucoma and ocular hypertension[4].
• Innovative Therapies: Continued innovation in ophthalmic treatments, including combination therapies, is expected to drive market growth and improve patient outcomes.
• Regulatory Environment: Navigating stringent regulatory frameworks will remain crucial for market entry and expansion, especially for generic versions of Latanoprost[4].

Key Takeaways

• The global Latanoprost market is valued at USD 1521.2 million in 2024, with a CAGR of 2.5% from 2024 to 2031.
• The fixed-dose combination of Netarsudil and Latanoprost has shown significant efficacy in reducing IOP.
• Santen Pharmaceutical and other key players are driving market growth through strong sales and cost optimization.
• Market drivers include an aging population, healthcare advancements, and the efficacy of combination therapies.
• Challenges include patent expirations, regulatory scrutiny, and regional market variations.

FAQs

Q1: What is the current global market size for Latanoprost?

The global Latanoprost market size is estimated to be USD 1521.2 million in 2024[4].

Q2: What is the expected CAGR for the Latanoprost market from 2024 to 2031?

The expected CAGR for the Latanoprost market from 2024 to 2031 is 2.5%[4].

Q3: Which region dominates the Latanoprost market?

North America dominates the Latanoprost market, accounting for more than 40% of the global revenue[4].

Q4: What are the key drivers for the Latanoprost market?

Key drivers include an aging population, healthcare advancements, and the efficacy of combination therapies like Netarsudil and Latanoprost[4].

Q5: What challenges does the Latanoprost market face?

Challenges include patent expirations, regulatory scrutiny, and regional market variations[4].

Sources

1. Patsnap: Latanoprost/Netarsudil dimesylate - Drug Targets, Indications, Patents.
2. Santen Pharmaceutical: Q1 FY2023 Financial Results.
3. Santen Pharmaceutical: Summary of Consolidated Financial Results for the Year Ended March 31, 2021.
4. Cognitive Market Research: Latanoprost Market Report.