OMIDENEPAG ISOPROPYL - Generic Drug Details

What are the generic drug sources for omidenepag isopropyl and what is the scope of patent protection?

Omidenepag isopropyl is the generic ingredient in one branded drug marketed by Visiox Pharma and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omidenepag isopropyl has one hundred and twenty-nine patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for OMIDENEPAG ISOPROPYL

International Patents:	129
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	1
Patent Applications:	44
What excipients (inactive ingredients) are in OMIDENEPAG ISOPROPYL?	OMIDENEPAG ISOPROPYL excipients list
DailyMed Link:	OMIDENEPAG ISOPROPYL at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for OMIDENEPAG ISOPROPYL

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

Sponsor	Phase
Santen Pharmaceutical Asia Pte. Ltd.	Phase 4

See all OMIDENEPAG ISOPROPYL clinical trials

Pharmacology for OMIDENEPAG ISOPROPYL

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

Anatomical Therapeutic Chemical (ATC) Classes for OMIDENEPAG ISOPROPYL

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

US Patents and Regulatory Information for OMIDENEPAG ISOPROPYL

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	10,179,127		Y
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No	9,415,038		Y
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	8,648,097		Y	Y
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No

International Patents for OMIDENEPAG ISOPROPYL

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019131901
South Korea	102281620
Canada	2757291	COMPOSITION PHARMACEUTIQUE POUR LA PREVENTION OU LE TRAITEMENT DU GLAUCOME (PHARMACEUTICAL COMPOSITION FOR TREATING OR PREVENTING GLAUCOMA)
Portugal	2415763
Denmark	2415763
European Patent Office	3093018	PRÉPARATION PHARMACEUTIQUE COMPRENANT UN COMPOSÉ D'ACIDE PYRIDYLAMINO-ACÉTIQUE (PHARMACEUTICAL PREPARATION INCLUDING PYRIDYLAMINO ACETIC ACID COMPOUND)

OMIDENEPAG ISOPROPYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omidenepag Isopropyl

Introduction

Omidenepag isopropyl, a topical ocular hypotensive agent, has been making significant strides in the treatment of glaucoma and ocular hypertension. This article delves into the market dynamics and financial trajectory of this drug, highlighting its clinical significance, market performance, and the financial impact on its developer, Santen Pharmaceutical.

Clinical Significance of Omidenepag Isopropyl

Omidenepag isopropyl is a prodrug that quickly metabolizes to its active metabolite, omidenepag, a selective agonist for the prostaglandin E2 (EP2) receptor. This mechanism of action is distinct from other commonly used prostaglandin analogs (PGAs) that act on the FP receptor, making it a novel option for patients who do not respond adequately to traditional treatments[1][4].

Market Approval and Expansion

Omidenepag isopropyl was first approved in Japan in 2018 for the treatment of glaucoma and ocular hypertension under the name EYBELIS. In September 2022, it received FDA approval in the United States, marking a significant milestone in its global expansion[1][4].

Clinical Trials and Efficacy

The drug has undergone extensive clinical trials, including the Phase 3 SPECTRUM program in the United States. These trials compared the efficacy of omidenepag isopropyl with timolol maleate, demonstrating that omidenepag isopropyl is non-inferior in reducing intraocular pressure (IOP) and is generally safe and well-tolerated[4].

Market Performance

Revenue Growth

Santen Pharmaceutical, the developer of omidenepag isopropyl, has seen significant revenue growth driven in part by the success of this drug. In the fiscal year ended March 2022, Santen's revenue increased by 6.7% year-on-year to ¥266.3 billion, with steady growth in mainstay products including ophthalmic solutions like omidenepag isopropyl[2].

Regional Contributions

The drug has contributed to revenue growth across various regions. In China, despite challenges like volume-based purchasing, omidenepag isopropyl has been part of the sales promotion efforts that have strengthened Santen's market position. In Asia (excluding China) and EMEA, the drug has also played a role in the steady growth of mainstay ophthalmic products[2][3].

Financial Impact

The approval and market performance of omidenepag isopropyl have positively impacted Santen's financials. The company reported a significant increase in operating profit and net profit in the fiscal year ended March 2022, with operating profit increasing by 194.5% year-on-year to ¥35.9 billion[2].

Financial Trajectory

Revenue and Profitability

In FY2023, Santen achieved its highest revenue and core operating profit, with revenue reaching ¥302.0 billion, a 8.2% increase year-on-year. The core operating profit increased by 41.9% to ¥62.8 billion, reflecting the strong performance of new and mainstay products, including omidenepag isopropyl[5].

Cost and Expense Management

Santen has also focused on cost and expense management, completing structural reforms that have improved profitability. The company reduced SG&A expenses and non-core expenses, contributing to an improved financial trajectory[5].

Research and Development

The success of omidenepag isopropyl has also supported Santen's R&D efforts. The company has made progress in various therapeutic areas, including myopia and ptosis, and has approved new products like Alesion eyelid cream in Japan and Catiolanze in EMEA[5].

Challenges and Opportunities

Market Competition

Omidenepag isopropyl faces competition from established treatments like latanoprost, but its unique mechanism of action provides a differentiated therapeutic option. This differentiation is crucial in a market where not all patients respond adequately to traditional treatments[1][4].

Regulatory Environment

The regulatory environment, including drug price revisions and volume-based purchasing, can impact sales. However, Santen has managed to minimize these impacts through strong sales promotion and market expansion strategies[2][3].

Global Expansion

The FDA approval in the United States opens up new market opportunities for omidenepag isopropyl. As the drug continues to expand globally, it is expected to contribute significantly to Santen's revenue and profitability[1][4].

Key Takeaways

• Clinical Significance: Omidenepag isopropyl offers a novel mechanism of action as an EP2 receptor agonist, providing an alternative for patients not responding to traditional treatments.
• Market Approval: Approved in Japan in 2018 and in the United States in 2022, with ongoing global expansion.
• Revenue Growth: Contributed to Santen's revenue growth across various regions, including China, Asia, and EMEA.
• Financial Impact: Positively impacted Santen's operating profit and net profit, with significant year-on-year increases.
• Cost Management: Supported by structural reforms that improved profitability through reduced SG&A and non-core expenses.
• R&D Progress: Supported Santen's R&D efforts in various therapeutic areas.

FAQs

Q: What is the mechanism of action of omidenepag isopropyl?

A: Omidenepag isopropyl is a prodrug that metabolizes to omidenepag, a selective agonist for the prostaglandin E2 (EP2) receptor, increasing aqueous humor outflow through both uveoscleral and trabecular pathways[1][4].

Q: Where was omidenepag isopropyl first approved?

A: Omidenepag isopropyl was first approved in Japan in 2018 under the name EYBELIS[1][4].

Q: How does omidenepag isopropyl compare to other glaucoma treatments?

A: Omidenepag isopropyl has a unique mechanism of action compared to traditional prostaglandin analogs (PGAs), making it a differentiated therapeutic option for patients who do not respond adequately to other treatments[1][4].

Q: What are the common side effects of omidenepag isopropyl?

A: Common side effects include pigmentation of the iris, periorbital tissue, and eyelash, as well as eyelash changes and ocular inflammation. In patients with pseudophakia, it may also lead to macular edema[1].

Q: How has the approval of omidenepag isopropyl impacted Santen's financials?

A: The approval and market performance of omidenepag isopropyl have significantly contributed to Santen's revenue growth and improved profitability, with notable increases in operating profit and net profit[2][5].

Sources

1. DrugBank: Omidenepag isopropyl: Uses, Interactions, Mechanism of Action.
2. Santen Pharmaceutical: Summary of Year End Financial Results | March 2022.
3. Santen Pharmaceutical: Q1 FY2023 Financial Results.
4. Santen Pharmaceutical: Santen Announces Initiation of Phase 3 Clinical Development for Omidenepag Isopropyl.
5. Santen Pharmaceutical: FY2023 Financial Results.