IOPIDINE Drug Patent Profile

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

Iopidine is a drug marketed by Harrow Eye and is included in two NDAs.

The generic ingredient in IOPIDINE is apraclonidine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apraclonidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iopidine

A generic version of IOPIDINE was approved as apraclonidine hydrochloride by RISING on March 12^th, 2009.

Summary for IOPIDINE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	1
Patent Applications:	397
Drug Prices:	Drug price information for IOPIDINE
What excipients (inactive ingredients) are in IOPIDINE?	IOPIDINE excipients list
DailyMed Link:	IOPIDINE at DailyMed

See drug prices for IOPIDINE

Recent Clinical Trials for IOPIDINE

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 4

See all IOPIDINE clinical trials

Pharmacology for IOPIDINE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

US Patents and Regulatory Information for IOPIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	AT	RX	Yes	Yes
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987		RX	Yes	Yes

Expired US Patents for IOPIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987

International Patents for IOPIDINE

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

Country	Patent Number	Title	Estimated Expiration
Germany	3269242
European Patent Office	0081924	TOPICAL COMPOSTIONS FOR LOWERING INTRAOCULAR PRESSURE
Austria	18006
Japan	H0453846
Netherlands	950008
Canada	1201066	SOLUTIONS DE N-[3,5-DICHLORO-4-(2- IMIDAZOLIDINYLIDENE-AMINO)-PHENYL]-ACETAMIDE POUR DIMINUER LA PRESSION INTRA-OCULAIRE (N-[3,5-DICHLORO-4-(2-IMIDAZOLIDINYLIDENEAMINO)- PHENYL]-ACETAMIDE SOLUTIONS FOR LOWERING INTRAOCULAR PRESSURE)
Japan	S58116417	METHOD OF LOWERING INTRAOCULAR PRESSURE

Supplementary Protection Certificates for IOPIDINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0081924	SPC/GB93/103	United Kingdom		SPC/GB93/103:, EXPIRES: 20071118

IOPIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IOPIDINE

Introduction to IOPIDINE

IOPIDINE, an ophthalmic drug, is part of the broader ophthalmic drugs market, which is experiencing significant growth driven by increasing eye illnesses and advancements in pharmaceutical technology.

Market Context

The global ophthalmic drugs market is projected to grow substantially, with estimates suggesting it will reach USD 62.55 billion by 2030, growing at a CAGR of 7.4% during the forecast period (2022-2030)[1][4].

Regional Market Dynamics

North America

North America is the most significant global ophthalmic drugs market shareholder, expected to grow at a CAGR of 6.7% during the forecast period. This growth is fueled by the increasing prevalence of eye illnesses and heightened public awareness of eye ailments. Major players like Pfizer Inc., Alcon, and Bausch and Lomb are key contributors to this region's growth[1][4].

Product Specifics: IOPIDINE

Commercial Availability

In June 2022, Harrow Health Inc. announced the commercial availability of IOPIDINE 1% in the United States. This move is part of Harrow's strategy to expand its product portfolio and strengthen its presence in the ophthalmic pharmaceutical market[1][4].

Market Impact

The introduction of IOPIDINE 1% is expected to contribute to the growth of Harrow Health Inc.'s revenues. For instance, in 2022, Harrow reported a significant increase in revenues, partly due to the addition of profits from IOPIDINE, MAXITROL, and MOXEZA (the “New Products”)[3].

Financial Performance

Revenue Growth

Harrow Health Inc.'s financial performance has been robust, with annual revenues increasing by 232% from $26.7 million to $88.6 million between the periods, representing a 35% CAGR. The inclusion of IOPIDINE and other new products has been a key factor in this growth[2].

Quarterly Performance

In the first quarter of 2022, Harrow reported revenues of $22.1 million, a 43% increase over the prior-year quarter, largely due to increased unit volumes sold and commissions from products like DEXYCU, as well as the profit transfer from IOPIDINE and other new products[3].

Gross Margins and EBITDA

Harrow's core gross margins have been strong, with a core gross margin of 75% in the first quarter of 2022. Adjusted EBITDA for the first quarter of 2022 was $4.9 million, indicating healthy profitability. The company expects gross margins from branded products like IOPIDINE to be larger than those from their compounding business, further enhancing overall gross margins[3].

Future Projections

Revenue Guidance

For FY24, Harrow has provided revenue guidance of at least $180 million, indicating a 38% increase over FY23 revenues. This growth is anticipated to be driven by the continued success of products like IOPIDINE and the launch of new branded products[5].

Operational Efficiency

Harrow is focusing on strengthening its infrastructure and commercial activities, which includes the addition of key talent and investments in sales and marketing efforts. These initiatives are expected to support the growth of IOPIDINE and other branded products[2][3].

Regulatory Environment

FDA Guidelines

The new FDA guidelines under the Prescription Drug User Fee Act provide a structured framework for assessing the risks and benefits of clinical trials for ophthalmic drugs, including IOPIDINE. This regulatory support is crucial for the market growth and approval of new ophthalmic drugs[1][4].

Competitive Landscape

Key Players

The ophthalmic drugs market is highly competitive, with major players like Pfizer Inc., Alcon, and Bausch and Lomb. Harrow Health Inc.'s strategic acquisitions and product launches, such as IOPIDINE, position it to compete effectively in this market[1][4].

Challenges and Opportunities

Market Acceptance

The success of IOPIDINE and other ophthalmic drugs depends on market acceptance and regulatory approvals. Harrow's focus on expanding its product portfolio and enhancing its commercial infrastructure is critical to overcoming these challenges[5].

Research and Development

Continuous research and development are essential for the growth of the ophthalmic drugs market. Harrow's investments in R&D, including the evaluation of several compounds for FDA approval, are expected to drive future growth[2][3].

Key Takeaways

• Market Growth: The ophthalmic drugs market, including products like IOPIDINE, is expected to grow significantly due to increasing eye illnesses and public awareness.
• Revenue Increase: Harrow Health Inc.'s revenues have seen substantial growth, partly due to the commercial availability of IOPIDINE.
• Regulatory Support: New FDA guidelines provide a structured framework for clinical trials, supporting market growth.
• Competitive Positioning: Harrow's strategic moves position it competitively in the ophthalmic drugs market.
• Future Projections: Harrow expects continued revenue growth driven by branded products like IOPIDINE.

FAQs

Q: What is the projected growth rate of the global ophthalmic drugs market? A: The global ophthalmic drugs market is projected to grow at a CAGR of 7.4% during the forecast period (2022-2030)[1].

Q: Which region is the most significant shareholder in the global ophthalmic drugs market? A: North America is the most significant global ophthalmic drugs market shareholder, expected to grow at a CAGR of 6.7% during the forecast period[1].

Q: When was IOPIDINE 1% made commercially available in the United States? A: IOPIDINE 1% was made commercially available in the United States in June 2022 by Harrow Health Inc.[1][4].

Q: How has Harrow Health Inc.'s revenue been impacted by the inclusion of IOPIDINE? A: Harrow Health Inc.'s revenues have seen significant growth, partly due to the addition of profits from IOPIDINE and other new products[3].

Q: What is Harrow Health Inc.'s revenue guidance for FY24? A: Harrow Health Inc. has provided revenue guidance of at least $180 million for FY24, indicating a 38% increase over FY23 revenues[5].

Cited Sources

1. Straits Research: Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030
2. Harrow Health, Inc.: Letter to Stockholders March 23, 2023
3. Harrow Health, Inc.: Letter to Stockholders May 5, 2022
4. Polaris Market Research: Ophthalmic Drugs Market Size, Share, Analysis Research Report
5. Avise Analytics: Harrow Inc: Envisioning a Bright Future