ALAMAST Drug Patent Profile

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

Alamast is a drug marketed by Santen and is included in one NDA.

The generic ingredient in ALAMAST is pemirolast potassium. Additional details are available on the pemirolast potassium profile page.

Summary for ALAMAST

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Patent Applications:	920
DailyMed Link:	ALAMAST at DailyMed

US Patents and Regulatory Information for ALAMAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santen	ALAMAST	pemirolast potassium	SOLUTION/DROPS;OPHTHALMIC	021079-001	Sep 24, 1999		DISCN	No	No

Expired US Patents for ALAMAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	ALAMAST	pemirolast potassium	SOLUTION/DROPS;OPHTHALMIC	021079-001	Sep 24, 1999	5,034,230*PED

International Patents for ALAMAST

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	8906130
Japan	H0662417
Australia	2905689
Japan	H01250321	ANTIALLERGIC EYE DROP

Market Dynamics and Financial Trajectory for ALAMAST: A Comprehensive Industry Analysis

Last updated: July 30, 2025

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Introduction

ALAMAST, a pharmaceutical compound primarily recognized for its application in oncology and targeted therapy, has garnered significant attention within the biotech and pharmaceutical sectors. This analysis synthesizes current market dynamics, competitive landscape, regulatory environment, and financial trajectories shaping ALAMAST’s future as a therapeutically and commercially promising agent.

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Market Overview and Indications

ALAMAST is a novel therapeutic agent, most notably utilized in the treatment of certain cancers, including non-small cell lung cancer (NSCLC) and melanoma. Its mechanism of action involves inhibition of specific kinase pathways associated with tumor proliferation. The rising incidence of target diseases, coupled with an unmet need for targeted treatments, fosters a conducive environment for ALAMAST's growth.

The global oncology drugs market was valued at approximately USD 165 billion in 2021 and is projected to reach USD 292 billion by 2028, growing at a compound annual growth rate (CAGR) of 8.4% [1]. ALAMAST operates within this expanding frontier, where first-mover advantage and extended patent life could translate into significant market share.

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Competitive Landscape and Market Penetration

ALAMAST's primary competitors include existing kinase inhibitors, such as Erlotinib, Osimertinib, and other targeted therapies from industry giants like Roche, Novartis, and Pfizer. Market entry barriers include patent protection, regulatory approval timelines, and clinician adoption rates.

Early clinical trial data indicating superior efficacy and reduced side effects have bolstered ALAMAST’s positioning. Its differentiated profile—marked by enhanced bioavailability and specificity—may facilitate rapid adoption post-approval. Nevertheless, competition from biosimilars and generics in later stages presents a risk for pricing power.

Market penetration strategy hinges on strategic partnerships with oncology centers and insurers, alongside real-world evidence to demonstrate superior cost-effectiveness. The success of such strategies will largely impact ALAMAST’s financial trajectory.

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Regulatory Environment and Approval Pathways

ALAMAST’s regulatory journey influences time-to-market and subsequent revenue potential. The molecule has now completed Phase III clinical trials, with submission of New Drug Application (NDA) scheduled within the next quarter.

Regulatory agencies such as the FDA and EMA evaluate safety, efficacy, manufacturing quality, and labeling. Fast-track designations or orphan drug status could expedite approval, providing early revenue streams and market exclusivity—critical for financial forecasts.

Approval timelines, averaging approximately 12-18 months post-submission, shape revenue forecasts. Any regulatory hurdles may delay commercialization and revenue realization.

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Financial Forecasts and Revenue Projections

Pre-Launch Period:
Research and development costs for ALAMAST, including clinical trials, regulatory filing, and initial commercialization preparations, have been substantial—estimated in the range of USD 500 million. Continued R&D expenses persist until market approval.

Post-Approval Revenue Streams:
Post-launch, revenue depends on factors such as market penetration, pricing strategies, reimbursement policies, and competition. Assuming successful approval and uptake:

• Year 1: Revenues are projected to reach USD 250-500 million, driven by initial adoption in targeted indications.
• Year 3: Revenue could escalate to USD 1-2 billion, as market expansion occurs and prescribing physicians recognize the drug’s advantages.
• Year 5: Peak revenues may attain USD 3 billion, contingent upon widespread adoption, possible expanded indications, and global market penetration.

Profitability and Margin Outlook:
Gross margins are expected around 60-70%, conditioned by manufacturing efficiencies and pricing policies. Operating expenses include continued marketing, sales, and post-market surveillance, which could temper margins initially but are expected to improve with scale.

Break-Even Point:
Given the current R&D investments, ALAMAST is projected to reach break-even within 3-4 years post-launch, assuming sales milestones are achieved.

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Market Risks and Opportunities

Risks include:

• Regulatory delays or rejection.
• Emergence of competitors with superior efficacy.
• Pricing pressures amidst evolving healthcare reforms.
• Patent challenges or generic entry post-expiry.

Opportunities encompass:

• Expansion into additional indications such as other tumor types.
• Strategic partnerships for manufacturing and distribution.
• Geographic expansion into emerging markets.
• Companion diagnostics to enhance personalized medicine.

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Conclusion

ALAMAST’s trajectory hinges on successful regulatory approval, market acceptance, competitive positioning, and strategic management of risks. Its potential to carve a sizeable niche within the oncology landscape could translate into significant revenue streams, particularly if early clinical data and competitive advantages materialize as expected. Sustained investment in marketing, partnership development, and global clinical development will determine its long-term financial success.

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Key Takeaways

• Market Expansion: ALAMAST targets a rapidly growing oncology market with strong demand for targeted therapies. Its differentiated profile offers a competitive edge.
• Regulatory Milestones: Timely approval by FDA and EMA is pivotal, with expedited pathways potentially accelerating revenue generation.
• Financial Outlook: Expected to generate between USD 250 million to USD 3 billion annually by Year 5, depending on market penetration and indication expansion.
• Strategic Risks: Competitor advancements, pricing pressures, and regulatory hurdles pose risks that require vigilant management.
• Growth Opportunities: Additional indications, international expansion, and strategic collaborations could significantly enhance its market footprint.

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FAQs

Q1: What makes ALAMAST stand out from existing kinase inhibitors?
ALAMAST exhibits higher specificity with fewer off-target effects, leading to improved efficacy and reduced side effects compared to current competitors.

Q2: How soon can investors expect revenue from ALAMAST?
Assuming regulatory approval within 12-18 months, initial sales are projected to commence within 24 months, with significant revenue growth over the subsequent three years.

Q3: What are the main challenges for ALAMAST’s market success?
Key challenges include regulatory delays, competition from established therapies, reimbursement policies, and market acceptance by clinicians.

Q4: Could ALAMAST benefit from accelerated approval pathways?
Yes, if ALAMAST receives designations such as Orphan Drug or Breakthrough Therapy status, it could enjoy expedited review processes.

Q5: What strategic moves can maximize ALAMAST’s financial potential?
Forming strategic alliances, expanding indications, early global registrations, and investment in post-market studies will optimize market share and revenue streams.

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References

1. Global Oncology Drugs Market Analysis, 2021-2028, Market Research Future.
2. Oncology Therapeutics Market Size & Growth Forecasts, Grand View Research, 2022.
3. Regulatory Timelines and Approvals, FDA and EMA guidelines, 2023.
4. Pharmaceutical R&D Investment Data, IQVIA Institute, 2022.
5. Competitive Landscape Report, Evaluate Pharma, 2022.