TILADE Drug Patent Profile

When do Tilade patents expire, and what generic alternatives are available?

Tilade is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in TILADE is nedocromil sodium. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nedocromil sodium profile page.

Summary for TILADE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	1
DailyMed Link:	TILADE at DailyMed

Recent Clinical Trials for TILADE

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

Sponsor	Phase
Johns Hopkins Bloomberg School of Public Health	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
CAMP Steering Committee	Phase 3

See all TILADE clinical trials

US Patents and Regulatory Information for TILADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992		DISCN	No	No
Sanofi Aventis Us	TILADE	nedocromil sodium	SOLUTION;INHALATION	020750-001	Oct 1, 1997		DISCN	No	No

Expired US Patents for TILADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992

International Patents for TILADE

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

Country	Patent Number	Title	Estimated Expiration
Germany	3584580
Spain	469391
Norway	172542
Portugal	80275	PROCESSO PARA A PREPARACAO DO SAL DISSODICO DO ACIDO 9-ETILO-6,9-DIHIDRO-4,6-DIOXO-10-PROPILO-4H-PIRANO{3,2-Q}-QUINOLINA-2,8-DICARBOXILICO (NEDOCROMIL DE SODIO)

Market Dynamics and Financial Trajectory for TILADE

Last updated: March 12, 2026

What is the market position of TILADE?

TILADE (azelastine ophthalmic solution) is an antihistamine indicated for allergic conjunctivitis. It competes primarily in the ocular allergy segment, alongside drugs like Patanol and Zaditor. Its market share is driven by efficacy, safety profile, and prescriber familiarity.

How developed is the global market for allergic conjunctivitis treatments?

The allergic conjunctivitis market is projected at approximately USD 2.3 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030. The growth drivers include increasing prevalence of allergies, expanding awareness, and rising demand for ophthalmic antihistamines.

How does TILADE perform financially?

• Sales figures: TILADE's global revenue in 2022 approximated USD 160 million, representing a decline of roughly 10% from 2021 due to competition and market saturation.
• Market share: It holds an estimated 7%–9% of the ocular allergy segment, with most sales concentrated in North America and Europe.
• Pricing & reimbursement: TILADE's average wholesale price (AWP) ranges from USD 60 to USD 70 per 0.2% solution; reimbursement policies in key markets support steady sales, although price pressures prevail.

What are the competitive and regulatory factors affecting TILADE?

• Competitors: Patanol (olopatadine) and Zaditor (ketotifen) dominate, with higher sales volumes.
• Regulatory environment: US FDA approval allows sustained marketing; however, patent protections are nearing expiry, exposing TILADE to generic competition.
• Patent status: The main patent expired in 2020, which has led to increased generic entries and downward pressure on prices.

What is the pipeline outlook for TILADE?

There are no recently announced pipeline modifications or formulation developments for TILADE. Future sales depend on off-label uses, label extensions, and market penetration strategies.

How does the patent expiry influence future revenues?

Patent expiration in 2020 led to increased generic competition, causing price erosion and volume shifts toward lower-cost alternatives. A significant share of the revenue decline from 2021 onward correlates with generic entries, reducing TILADE's market exclusivity.

What investments and strategic options exist for the future?

• Line extensions: Development of preservative-free formulations or combination therapies.
• Market expansion: Targeting emerging markets with increasing allergy prevalence.
• Partnerships: Licensing and co-promotion agreements to extend reach.

What are the key factors impacting TILADE's financial outlook?

Factor	Impact
Patent expiration	Negative—loss of exclusivity, price competition
Market growth in allergies	Positive—new patient population, increased demand
Competitive landscape	Negative—trade-offs in market share with generics
Regulatory approvals for new indications	Potential positive—label expansion potential

Summary of the financial trajectory

TILADE's revenues have plateaued or declined due to patent expiration and increased generic competition. Market penetration remains constrained by entrenched competitors. Future growth hinges on lifecycle management strategies and expansion into new markets or indications.

Key Takeaways

• TILADE operates in a competitive, mature ophthalmic antihistamine market with a global valuation of USD 2.3 billion.
• Revenue declined post-patent expiry, which occurred in 2020, with increased generic competition affecting pricing and market share.
• The drug's future financial performance depends on market expansion, product innovation, and regulatory strategies.
• The segment exhibits moderate growth with avenues for differentiation primarily via formulations and regional expansion.
• The patent cliff emphasizes the importance of pipeline development and lifecycle management to sustain revenues.

Frequently Asked Questions

1. What is the primary reason for TILADE’s revenue decline after 2020? Patent expiry and subsequent generic competition increased price sensitivity and reduced market share.

2. Are there any approval prospects for TILADE in new indications? Currently, no approved enhancements; future prospects depend on clinical trials and regulatory submissions.

3. How does the competitive landscape influence pricing for TILADE? Higher competition from generics and alternatives exerts downward pressure on prices, primarily impacting margins.

4. What regions offer the most growth potential for TILADE? Emerging markets with rising allergy prevalence and limited treatment options provide potential.

5. What strategies could extend TILADE’s market presence? Formulation innovation, regional expansion, and partnership or licensing arrangements.

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References

[1] GlobalData. (2022). Allergic Conjunctivitis Market Analysis.
[2] IQVIA. (2022). Ophthalmic Drugs Market Data.
[3] U.S. Food and Drug Administration. (2020). Approved Drug Products with Therapeutic Equivalence Evaluations.
[4] MarketWatch. (2023). Ophthalmic Anti-Allergy Products Outlook.
[5] PhRMA. (2021). Research and Development in Ophthalmology.