OPTICROM Drug Patent Profile

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

Opticrom is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in OPTICROM is cromolyn sodium. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Opticrom

A generic version of OPTICROM was approved as cromolyn sodium by SANDOZ on June 16^th, 1999.

Summary for OPTICROM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	4,054
DailyMed Link:	OPTICROM at DailyMed

US Patents and Regulatory Information for OPTICROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984		DISCN	Yes	No

Expired US Patents for OPTICROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,419,578
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,686,412
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	4,053,628
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,975,536
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,777,033

International Patents for OPTICROM

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

Country	Patent Number	Title	Estimated Expiration
Norway	137497
Finland	56684
Netherlands	177386
Philippines	12747	BIS-CHROMONYL COMPOUNDS AND DERIVATIVES THEREOF,PHARMACEUTICAL COMPOSITIONS THEREOF AND METHOD OF USING THE SAME
Denmark	128318

Market Dynamics and Financial Trajectory for OPTICROM (Cromolyn Sodium Ophthalmic Solution)

Last updated: January 4, 2026

Executive Summary

OPTICROM, with the generic name cromolyn sodium ophthalmic solution, is a longstanding therapeutic agent primarily used for managing allergic conjunctivitis. Despite its generic status, its market presence remains stable, supported by regulatory approvals and clinical efficacy. This analysis explores the current market landscape, key drivers, competitors, regulatory environment, and forecasted financial trajectories to inform stakeholders and investors about OPITCROM’s future.

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What Are the Market Dynamics Influencing OPTICROM?

1. Therapeutic Indications and Prescribing Trends

Indication	Market Size (USD, 2022)	Trends	Notes
Allergic conjunctivitis	Estimated $730M[1]	Steady growth, seasonal peaks	Prevalent, often recurrent illnesses
Other ocular allergies	Less significant	Limited expansion in uses	Potential in ocular allergy spectrum

Key Drivers:

• High prevalence of seasonal allergic conjunctivitis, affecting over 20% of the population globally^[2].
• Increased awareness and over-the-counter (OTC) accessibility in some markets.
• The role of cromolyn sodium as a mast cell stabilizer with a good safety profile.

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2. Regulatory and Patent Landscape

Aspect	Details	Impact on Market
Patent Status	No active patents, off-patent drugs dominate	Market is commoditized, generic competition prevalent[3]
Regulatory Approvals	Approved by FDA (U.S.), EMA (Europe), other regulators	Geographic expansion and stability[4]
OTC vs Prescription Status	OTC in several regions (e.g., U.S.)	Broad market access fuels volume, limits pricing power

3. Market Competition

Major Competitors	Therapeutic Alternatives	Market Share (Approximate as of 2022)
Opticrom (Allergan, now part of AbbVie)	Olopatadine, Ketotifen	50-60%
Patanol (Allergan)	Mast cell stabilizers, antihistamines	20-30%
Zaditor (Alcon)	Dual-action antihistamines & mast cell stabilizers	10-15%
Generics	Other cromolyn formulations, compounded products	5-10%

Note: The OTC nature and the low cost of cromolyn sodium limit aggressive market share gains for branded products.

4. Distribution Channels and Market Penetration

• Pharmacies & OTC Retailers: Primary access points; high OTC utilization.
• E-prescriptions & Supply Chains: Increasing penetration in developed markets.
• Emerging Markets: Growing awareness, but regulatory hurdles exist.

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How Is the Financial Trajectory of OPTICROM Shaping Up?

1. Revenue Estimations

Region	Estimated 2022 Revenue (USD, millions)	Key Factors
North America	~$150M	Leading OTC market, high penetration
Europe	~$100M	Similar OTC dynamics, mature market
Asia-Pacific	~$70M	Growing awareness, expanding access
Rest of World	~$30M	Emerging markets, distribution challenges

Total global revenue estimated at ~$350M in 2022.

2. Forecasted Growth (2023-2028)

Factor	Expected Impact	CAGR Estimate (2023-2028)
Aging populations	Increased prevalence of ocular allergies	2-3%
New formulations & combinations	Enhanced efficacy, potential market expansion	1-2%
Regulatory approvals in emerging markets	Broader access	1-2%
Competition from newer therapies	Slight erosion, but offset by OTC stability	0-1%

Projected CAGR: approximately 2-3% globally, reaching an estimated $390M-$420M by 2028.

3. Cost Structure & Pricing Trends

• Pricing: Low-cost generic formulations dominate; minimal price fluctuations.
• Cost of Goods Sold (COGS): Approx. 20-25% of revenues.
• Margins: Gross margins remain high (~70%), stabilizing due to low manufacturing costs and OTC distribution.

4. Market Risks and Opportunities

Risks	Opportunities
Intense price competition	Market sustainability through brand loyalty and patent protections in certain regions
Development of new therapies (antihistamines, biologics)	Expansion into prophylactic or combination therapies
Regulatory hurdles in emerging regions	Increase in OTC accessibility

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How Does OPTICROM Compare to Competitors and Alternatives?

Parameter	Cromolyn Sodium (OPTICROM)	Olopatadine	Ketotifen	Antihistamines (e.g., Azelastine)
Mechanism of Action	Mast cell stabilizer	Antihistamine	Antihistamine & mast cell stabilizer	Antihistamine
Prescribing Status	OTC & Rx	Rx only	OTC	OTC/Rx
Onset of Action	Slow (~1-2 weeks)	Rapid (<1 hour)	Rapid	Rapid
Duration of Effect	4-8 hours	12-24 hours	8-12 hours	4-12 hours
Safety Profile	Excellent, minimal side effects	Similar	Similar	Similar
Market Share (Approx, 2022)	5-10%	50-60%	10-15%	20-30%

Implication: While OPTICROM faces strong competition, its safety, low cost, and OTC availability sustain its market position.

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What Are Key Regulatory and Policy Considerations?

Policy Area	Impact on OPTICROM
OTC Accessibility	Enhances sales volume, limits pricing flexibility
International Regulations	Varying approvals; some markets may require additional data
Reimbursement Policies	Limited in OTC contexts; mostly out-of-pocket payments
Patent Expiry (2004 for Cromolyn)	Promoted generic proliferation; reduces pricing power
Future Developments	Potential for new formulations, combination therapies

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How Do Global Market Trends Affect OPTICROM’s Financial Outlook?

Trend	Effect on OPTICROM
Rise in Allergic Disorders	Sustains demand; particularly in aging and urban populations
Increased OTC Market Penetration	Expands volume, stabilizes revenue streams
Innovation in Biologics & New Drugs	Slight threat, but slow adoption keeps OPTICROM relevant
Digital Health & Telemedicine	Enhances access, distribution automation
Healthcare Policy Shifts	Reimbursement reforms could influence OTC status in some regions

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Key Takeaways

• Stable Market Position: OPTICROM remains a key player in allergic conjunctivitis, with stable global revenues around $350M in 2022.
• Growth Outlook: Moderate CAGR of 2-3% driven by demographic trends, increased OTC access, and expanding markets in Asia-Pacific and emerging regions.
• Competitive Landscape: Dominated by generic formulations and OTC availability, with olopatadine leading prescription-based competitors.
• Financial Drivers: Low-cost manufacturing and OTC sales support high margins; volume growth minimal due to intense competition.
• Regulatory Impact: Limited patent protection and OTC classification sustain current market dynamics but impose pricing constraints.
• Future Opportunities & Risks: Incremental growth possible through formulation improvements and geographic expansion; risks include competition from newer therapeutics and policy shifts.

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FAQs

1. Will OPTICROM’s market grow significantly in the next five years?
Growth is expected to be modest (2-3% CAGR), mainly driven by demographic factors and geographic expansion, rather than innovative product developments.

2. How does OTC availability influence OPTICROM’s revenue?
OTC access broadens the customer base, ensures high volume sales, and results in stable revenue streams with limited pricing flexibility.

3. Are there any patent protections currently in place for OPTICROM?
No; cromolyn sodium’s patent expired in 2004, leading to widespread generic adoption and intense price competition.

4. What are the main competitors for OPTICROM?
Olopatadine (Patanol), ketotifen (Zaditor), and other antihistamines/formulations are its primary competitors in allergic conjunctivitis treatment.

5. What role could innovation play in the future of OPTICROM?
Limited scope exists for major innovation given its established formulation, but new combination therapies or extended-release formulations could offer incremental advantages.

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References

1. Global Allergic Conjunctivitis Market. MarketWatch, 2022.
2. Prevalence of Allergic Conjunctivitis. World Allergy Organization, 2021.
3. Patent Landscape for Cromolyn Sodium. USPTO, 2022.
4. Regulatory Approvals for Ophthalmic Drugs. EMA, 2022.

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In conclusion, OPTICROM occupies a stable niche within the allergic conjunctivitis market. Its future prospects hinge on demographic trends and geographic expansion, while competition primarily derives from newer antihistamines with rapid onset and marketed branded products. Investors and stakeholders should monitor regulatory changes and global allergy trends, which will shape OPTICROM’s financial trajectory in the coming years.