OMLONTI Drug Patent Profile

Which patents cover Omlonti, and what generic alternatives are available?

Omlonti is a drug marketed by Visiox Pharma and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in thirty-two countries.

The generic ingredient in OMLONTI is omidenepag isopropyl. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.

DrugPatentWatch^® Generic Entry Outlook for Omlonti

Omlonti will be eligible for patent challenges on September 22, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 22, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMLONTI

International Patents:	129
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	28
What excipients (inactive ingredients) are in OMLONTI?	OMLONTI excipients list
DailyMed Link:	OMLONTI at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215092

Dosage:

SOLUTION;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 OMLONTI

Drug Class	Prostaglandin E2 Receptor Agonist
Mechanism of Action	Prostaglandin E2 Receptor Agonists

US Patents and Regulatory Information for OMLONTI

OMLONTI is protected by eleven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No	11,666,563
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No	11,793,798		Y
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No	10,179,127		Y
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No

International Patents for OMLONTI

See the table below for patents covering OMLONTI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021006593
South Korea	20170013994	N-치환 술폰아미드 화합물 및 그의 제조 방법 (N- N-SUBSTITUTED SULFONAMIDE COMPOUND AND METHOD FOR PRODUCING SAME)
Slovenia	2264009
China	108743587	含有吡啶基氨基乙酸化合物的药物制剂 (PHARMACEUTICAL PREPARATION INCLUDING PYRIDYLAMINO ACETIC ACID COMPOUND)

OMLONTI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMLONTI

Introduction to OMLONTI

OMLONTI, developed by Santen Pharmaceutical Co., Ltd., and UBE Corporation, is a significant addition to the ophthalmic drugs market. Approved by the U.S. Food and Drug Administration (FDA) in June 2022, OMLONTI is designed to reduce high intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension[1][4].

Market Context

The global ophthalmic drugs market is experiencing robust growth, driven by increasing prevalence of eye-related disorders, an aging population, and advancements in drug development technologies. The market is estimated to reach USD 51.46 billion by 2029, growing at a CAGR of 8.24% from 2024 to 2029[3].

Approval and Regulatory Impact

The FDA approval of OMLONTI marks a significant milestone in the treatment of open-angle glaucoma and ocular hypertension. This approval not only expands the treatment options available to patients but also underscores the regulatory environment's support for innovative ophthalmic drugs. Such approvals are crucial for driving market growth and encouraging further research and development in the sector[1][4].

Market Growth Drivers

Several factors are driving the growth of OMLONTI and the broader ophthalmic drugs market:

Increasing Prevalence of Ocular Conditions

The rising burden of ocular disorders globally is a key driver. As the population ages, the incidence of conditions like glaucoma and ocular hypertension increases, leading to higher demand for effective treatments[3][4].

Advancements in Drug Development

Technological advancements in drug formulation and delivery systems are enhancing the efficacy and safety of ophthalmic drugs. OMLONTI, with its ability to lower IOP effectively, is a testament to these advancements[1][3].

Generic and Branded Drug Dynamics

The market is also influenced by the increasing demand for generic ophthalmic drugs, which offer a cost-effective alternative to branded drugs. However, the approval of new branded drugs like OMLONTI indicates a balanced market where both generic and branded options coexist and drive growth[4].

Financial Performance of Santen Pharmaceutical

Santen Pharmaceutical, the developer of OMLONTI, has shown strong financial performance in recent years:

Revenue Growth

In FY2023, Santen achieved its highest revenue, with a year-over-year increase of 8.2% to JPY 302.0 billion. This growth is partly attributed to the strong performance of mainstay products and the recovery from the COVID-19 pandemic[5].

Core Operating Profit

The company's core operating profit (Core OP) saw a significant increase of 41.9% year-over-year to JPY 62.8 billion in FY2023. This improvement is due to cost optimization, structural reforms, and strong sales performance in key markets[5].

Regional Contributions

Santen's financial results show significant contributions from regions such as China, Asia, and EMEA. For instance, the company experienced a market recovery in China and steady growth in key Asian and EMEA markets, which contributed to the overall revenue and profit growth[5].

Impact of OMLONTI on Santen’s Financials

The approval and launch of OMLONTI are expected to contribute positively to Santen’s financial trajectory:

Sales Momentum

OMLONTI is anticipated to add to the sales momentum of Santen’s new products. The drug’s approval and subsequent market entry are part of the company’s medium-long term growth strategy, which includes pursuing commercial excellence and expanding product portfolios[5].

Market Recovery

The post-COVID-19 market recovery has been favorable for Santen, with regions like China showing significant growth. OMLONTI’s introduction aligns with this recovery trend, potentially boosting sales and revenue in the ophthalmic segment[2][5].

Challenges and Restraints

While OMLONTI and the broader ophthalmic drugs market face several growth drivers, there are also challenges to consider:

Side Effects and Safety Concerns

One of the restraints on market growth is the potential side effects of ophthalmic drugs. Ensuring the safety and efficacy of drugs like OMLONTI is crucial to maintaining market trust and compliance[4].

Competitive Landscape

The ophthalmic drugs market is highly competitive, with both generic and branded drugs vying for market share. OMLONTI must compete with existing treatments and generic alternatives, which could impact its market penetration and revenue generation[4].

Key Takeaways

• Regulatory Approvals: The FDA approval of OMLONTI in June 2022 is a significant milestone for the treatment of open-angle glaucoma and ocular hypertension.
• Market Growth: The ophthalmic drugs market is expected to grow significantly, driven by increasing ocular conditions and advancements in drug development.
• Financial Performance: Santen Pharmaceutical has shown strong revenue and core operating profit growth, partly due to the performance of new products like OMLONTI.
• Regional Contributions: The company’s financial success is supported by strong contributions from regions such as China, Asia, and EMEA.
• Challenges: The market faces challenges including side effects of drugs and a competitive landscape.

FAQs

Q: What is OMLONTI, and what is it used for? A: OMLONTI is an ophthalmic medication approved by the FDA to treat open-angle glaucoma and ocular hypertension by reducing high intraocular pressure (IOP).

Q: Who developed OMLONTI? A: OMLONTI was developed by Santen Pharmaceutical Co., Ltd., and UBE Corporation.

Q: What is the expected market size of the ophthalmic drugs market by 2029? A: The global ophthalmic drugs market is forecast to reach USD 51.46 billion by 2029, growing at a CAGR of 8.24% from 2024 to 2029.

Q: How has the COVID-19 pandemic impacted the ophthalmic drugs market? A: The pandemic led to a slowdown in market expansion and revenue generation due to lockdowns, prioritization of COVID-19 patients, and conversion of ophthalmology clinics into COVID-19 wards. However, the market is now recovering.

Q: What are the key drivers of the ophthalmic drugs market? A: Key drivers include the increasing prevalence of eye-related disorders, an aging population, and advancements in drug development technologies.

Sources

1. Grand View Research: Glaucoma Market Size, Share, Trends Analysis Report, 2030.
2. Santen Pharmaceutical: Q1 FY2023 Financial Results.
3. Mordor Intelligence: Global Ophthalmic Drugs Market Size Research - Industry Trends & Share.
4. GlobeNewswire: Ophthalmic Drugs Market to Reach US$ 70.76 Billion by 2030, Says Coherent Market Insights.
5. Santen Pharmaceutical: FY2023 Financial Results.