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:	81
Clinical Trials:	1
Patent Applications:	461
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
Austria	18006
Canada	1194418	COMPOSITIONS A BASE DE 2-(PHENYLIMINO TRISUBSTITUE)- IMIDAZOLINE POUR L'ABAISSEMENT DE LA PRESSION INTRAOCULAIRE (2-(TRISUBSTITUTED PHENYLIMINO)-IMIDAZOLINE COMPOSITIONS FOR LOWERING INTRAOCULAR PRESSURE)
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)

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

Market Dynamics and Financial Trajectory for IOPIDINE (Apraclonidine)

Last updated: March 31, 2026

What Is IOPIDINE and Its Current Market Position?

IOPIDINE (apraclonidine hydrochloride) is a selective alpha-adrenergic receptor agonist initially developed for glaucoma management, mainly to reduce intraocular pressure (IOP). It is approved by the U.S. Food and Drug Administration (FDA) since 1987 for decreasing IOP in various ocular conditions. Its primary indication remains short-term management of postoperative or secondary ocular hypertension.

The drug faces limited dominant competitors such as brimonidine and timolol. Its market share has declined in the general glaucoma treatment space due to the emergence of drugs with better side-effect profiles and sustained efficacy.

How Has the Global Market for IOP-Lowering Agents Evolved?

Market Size and Growth

• The global glaucoma market was valued at approximately USD 4.2 billion in 2021.
• It is projected to expand at a compound annual growth rate (CAGR) of about 4.8% between 2022 and 2027, reaching USD 5.4 billion by 2027 (Fortune Business Insights, 2022).
• IOPIDINE's specific market share is estimated at less than 5% due to comparative limitations and generic competition.

Competitive Landscape

Drug Class	Key Drugs	Estimated Market Share (2022)	Notes
Beta-blockers	Timolol, Betaxolol	35-40%	First-line treatments in glaucoma management.
Alpha-adrenergic agonists	Brimonidine, Apraclonidine	15-20%	Used in combination or where beta-blockers are contraindicated.
Prostaglandins	Latanoprost, Bimatoprost	40-45%	Dominates the market due to efficacy and safety.
Others	Rho kinase inhibitors	5-10%	Emerging therapies.

IOPIDINE's limited adoption is due to its side-effect profile, such as ocular allergic reactions and tachyphylaxis, leading to decreased usage over recent years.

What Are the Regulatory and Patent Strategies Influencing Market Dynamics?

Patent Landscape

• Originated from Novartis and Alcon (original manufacturers).
• Patents expired or are nearing expiration in key markets; generic versions now available.
• Patent protections on IOPIDINE have mostly elapsed, reducing exclusivity.

Regulatory Developments

• No recent FDA approvals or new indications.
• No recent European Medicines Agency (EMA) approvals for marketing extensions.
• The lack of new formulations or delivery systems limits growth potential.

What Are the Key R&D Drivers and Investment Trends?

• Focus on combination therapies (e.g., with timolol or prostaglandins) to improve efficacy and reduce side effects.
• Development of sustained-release formulations for prolonged action.
• Exploration of synergistic effects with neuroprotective agents.
• Limited R&D pipelines for IOPIDINE itself; focus shifts elsewhere when it comes to alpha-adrenergic agents.

How Do Reimbursement and Pricing Policies Affect Commercial Performance?

• Reimbursement in major markets like the U.S. and EU favors drugs with proven safety profiles and long-term efficacy.
• IOPIDINE's side effects and the availability of cheaper generics suppress premium pricing strategies.
• Insurers’ reluctance to reimburse older drugs with competition reduces market penetration.

Financial Outlook and Investment Implications

• Current sales remain stable in niche indications but face downward pressure due to decline in usage.
• Market for IOPIDINE is unlikely to grow significantly due to patent expirations, safety profile issues, and market preferences for alternative agents.
• Pharmaceutical companies may repurpose or reformulate existing alpha-agonists, but IOPIDINE-specific opportunities are limited.

Revenue Projections (2023-2028)

Year	Estimated Revenue (USD millions)	Change from Prior Year	Notes
2023	20	-10%	Limited market due to generic competition.
2024	18	-10%	Continued erosion of market share.
2025	15	-17%	Market niche diminishes further.
2026	12	-20%	Marginalized in glaucoma treatments.
2027	10	-17%	Low revenue forecast.

What Are the Main Risks and Opportunities?

Risks

• Patent expirations and generic competition depress sales.
• Side effects hamper long-term adherence.
• The dominance of prostaglandins and combination therapies reduces market share.
• Regulatory hurdles for repurposing or new formulations.

Opportunities

• Development of fixed-dose combination drugs.
• Introduction of sustained-release delivery systems.
• Expansion into niche indications, such as neuroprotection or ocular hypertension secondary to other conditions.
• Potential for biosimilar development in markets with high demand.

Key Takeaways

• IOPIDINE's original market declined rapidly with emergence of safer, more effective drugs.
• The drug’s patent life has ended, making generic versions dominant.
• Limited R&D activity and regulatory activity constrain growth.
• The overall glaucoma market still favors prostaglandin-based therapies leading the segment.
• Investments in new formulations or combination therapies pose some potential but face stiff competition.

FAQs

1. Is IOPIDINE still a viable treatment option?
It is rarely used as a first-line therapy. Its role persists in specific cases, primarily where other agents are contraindicated or ineffective.

2. Will IOPIDINE see new patent protections or formulations?
No significant development or patent filings are known, limiting prospects for new formulations.

3. How does IOPIDINE compare to alternatives in safety and efficacy?
It has lower efficacy and a less favorable side-effect profile compared to newer agents like brimonidine or prostaglandins.

4. What is the outlook for companies holding IOPIDINE rights?
Revenue prospects decline as generic competition expands; strategic options involve formulation improvements or niche applications.

5. Are there ongoing clinical trials involving IOPIDINE?
Few, if any, recent trials are registered. Focus has shifted to newer therapies.

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References

1. Fortune Business Insights. (2022). Global Glaucoma Market Size, Share & Industry Analysis.
2. U.S. Food and Drug Administration. (1987). FDA Approval for IOPIDINE.
3. MarketWatch. (2023). Glaucoma Treatment Drugs Market and Competitive Landscape.
4. Novartis. (2018). Patent and Regulatory Status of Apraclonidine.
5. EMA. (2022). Approved Ocular Treatments and Indications.