IHEEZO Drug Patent Profile

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

Iheezo is a drug marketed by Harrow Eye and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-two patent family members in twenty-two countries.

The generic ingredient in IHEEZO is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iheezo

A generic version of IHEEZO was approved as chloroprocaine hydrochloride by HIKMA on September 9^th, 1998.

Summary for IHEEZO

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Patent Applications:	752
Drug Prices:	Drug price information for IHEEZO
What excipients (inactive ingredients) are in IHEEZO?	IHEEZO excipients list
DailyMed Link:	IHEEZO at DailyMed

See drug prices for IHEEZO

Pharmacology for IHEEZO

Drug Class	Ester Local Anesthetic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for IHEEZO

IHEEZO is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227-001	Sep 27, 2022		RX	Yes	Yes	10,792,271		Y
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227-001	Sep 27, 2022		RX	Yes	Yes

International Patents for IHEEZO

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

Country	Patent Number	Title	Estimated Expiration
Israel	273213	תכשירים מקומיים של כלורופרוקאין (Topical formulations of chloroprocaine)
European Patent Office	3681473	FORMULATIONS TOPIQUES DE CHLOROPROCAÏNE (TOPICAL FORMULATIONS OF CHLOROPROCAINE)
Canada	3070336	FORMULATIONS TOPIQUES DE CHLOROPROCAINE ET METHODES D'UTILISATION (TOPICAL FORMULATIONS OF CHLOROPROCAINE AND METHODS OF USING SAME)
Peru	20201281	FORMULACIONES TOPICAS DE CLOROPROCAINA Y METODOS PARA UTILIZAR LAS MISMAS

IHEEZO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: IHEEZO

Introduction

IHEEZO, a drug developed by Harrow Inc. (NASDAQ: HROW), has been making significant waves in the pharmaceutical industry, particularly in the ophthalmic sector. After its approval by the U.S. Food and Drug Administration (FDA) in September 2023, IHEEZO has shown remarkable growth and is poised to be a key driver of Harrow's financial success.

Approval and Initial Launch

IHEEZO, previously known as AMP-100, was approved by the FDA for ocular surface anesthesia, marking a significant milestone for Harrow as its first New Drug Application (NDA) product[4].

Early Adoption and Growth

Initially, IHEEZO faced a slow start, with only 1,000 total prescriptions written by early August 2023. However, the situation changed dramatically in September 2023, with prescription volumes ramping up significantly. By October and November 2023, the average monthly prescriptions increased to 4,000 units, and by December 2023, this number tripled to 12,000 units[1].

Market Acceptance

The rapid increase in prescriptions indicates strong market acceptance of IHEEZO. This growth is attributed to Harrow's effective market access strategy, which focuses on the ophthalmic surgical and office-setting markets, particularly in the cataract surgery segment[4].

Revenue Implications

IHEEZO's success has translated into substantial revenue growth for Harrow. By December 2023, IHEEZO was generating an estimated $5 million in monthly revenue, with a gross margin of 90%. This translates to an annual run rate of $40 million in pre-tax free cash flow, with an impressive 80% cash-on-cash return on the $50 million investment in IHEEZO[1].

Financial Performance

Harrow's financial results reflect the positive impact of IHEEZO. In the second quarter of 2024, Harrow reported record revenues of $48.9 million, a 46% increase year-over-year and 42% quarter-over-quarter. IHEEZO's customer unit demand volume increased by 98% from Q1 2024, contributing significantly to this growth[2].

Supply Agreements and Market Penetration

As of 2024, Harrow has secured 24 supply agreements for IHEEZO, including one with the largest U.S. retina practice group. These agreements are crucial for expanding IHEEZO's market reach and ensuring continued growth[2].

Regulatory Support

IHEEZO received confirmation from the Centers for Medicare & Medicaid Services (CMS) that it is separately reimbursable for unilateral and bilateral in-office procedures, retroactive to January 1, 2024. This reimbursement approval has likely eased the adoption process for IHEEZO[5].

Patent Protection

The U.S. Patent and Trademark Office granted new patent claims for IHEEZO, extending its patent protection through 2039. This extended patent protection will help Harrow maintain its competitive edge in the market[5].

Gross Margin and Profitability

IHEEZO's high gross margin of 90% is a significant contributor to Harrow's overall financial health. The company's gross margin improved to 74% in Q2 2024, up from 70% in Q2 2023, indicating efficient cost management and strong profitability potential[2].

Future Outlook

Harrow has guided to $180 million or more in revenue for 2024, with IHEEZO's current run rate already pushing this figure to $190 million. The launch of other branded drugs, such as VEVYE and the upcoming launch of Triesence, is expected to further boost revenues. If IHEEZO's success is replicated with these other drugs, Harrow's revenue could exceed $1 billion by 2027, significantly enhancing the company's stock value[1].

Competitive Landscape

While IHEEZO's success is promising, the pharmaceutical industry is highly competitive. Harrow's ability to maintain growth and achieve profitability will depend on continued product adoption, successful new product launches, and effective cost management[2].

Market Opportunity

The market opportunity for IHEEZO is substantial, particularly in the physician’s office setting of care, which is estimated to be double that of the ambulatory surgical center (ASC)/hospital setting. This positions IHEEZO for a multi-billion-dollar annual revenue opportunity[3].

Conclusion

IHEEZO's rapid adoption and financial performance have been nothing short of spectacular. From a slow start to achieving $5 million in monthly revenue, IHEEZO has become a cornerstone of Harrow's growth strategy. With strong market acceptance, favorable regulatory support, and a robust financial trajectory, IHEEZO is set to drive significant revenue growth for Harrow in the coming years.

Key Takeaways

• Rapid Market Adoption: IHEEZO's prescriptions increased dramatically from 1,000 in August 2023 to 12,000 in December 2023.
• Significant Revenue Growth: IHEEZO generated $5 million in monthly revenue by December 2023, contributing to Harrow's record Q2 2024 revenues.
• High Gross Margin: IHEEZO's 90% gross margin is a key contributor to Harrow's profitability.
• Regulatory Support: CMS reimbursement approval and extended patent protection through 2039 support IHEEZO's market position.
• Future Outlook: IHEEZO's success is expected to be replicated with other branded drugs, potentially driving Harrow's revenue to over $1 billion by 2027.

FAQs

Q: What is IHEEZO, and what is it used for? A: IHEEZO is a drug approved by the FDA for ocular surface anesthesia, primarily used in ophthalmic surgical and office-setting procedures.

Q: How has IHEEZO performed since its launch? A: After a slow start, IHEEZO saw a significant increase in prescriptions, reaching 12,000 units per month by December 2023, generating $5 million in monthly revenue.

Q: What are the key factors contributing to IHEEZO's success? A: Strong market access strategy, favorable regulatory support, high gross margin, and significant supply agreements have all contributed to IHEEZO's success.

Q: How does IHEEZO impact Harrow's financial outlook? A: IHEEZO's success is driving Harrow's revenue growth, with the company guiding to $180 million or more in revenue for 2024 and potentially exceeding $1 billion by 2027.

Q: What are the future prospects for IHEEZO and Harrow? A: With the launch of other branded drugs like VEVYE and Triesence, Harrow is poised for continued growth, potentially leading to a significant increase in stock value.

Sources

1. Seeking Alpha - Harrow's Drug Iheezo Is Off To A Great Start
2. Stock Titan - Harrow Announces Second Quarter 2024 Financial Results
3. Harrow Investors - Second Quarter 2023 Record Revenues
4. Harrow Investors - Letter to Stockholders November 14, 2022
5. Harrow Investors - Harrow Announces First Quarter 2024 Financial Results