PROSOM Drug Patent Profile

Which patents cover Prosom, and when can generic versions of Prosom launch?

Prosom is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in PROSOM is estazolam. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estazolam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prosom

A generic version of PROSOM was approved as estazolam by NOVITIUM PHARMA on July 3^rd, 1997.

Summary for PROSOM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	35
Patent Applications:	4,503
DailyMed Link:	PROSOM at DailyMed

US Patents and Regulatory Information for PROSOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990		DISCN	Yes	No
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990		DISCN	Yes	No

Expired US Patents for PROSOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990	3,987,052
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990	3,987,052

International Patents for PROSOM

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

Country	Patent Number	Title	Estimated Expiration
Germany	2065893
Denmark	449378
Hong Kong	61677	TRIAZOLOBENZODIAZEPINE DERIVATIVES
Switzerland	549040	VERFAHREN ZUR HERSTELLUNG VON 6-(2,6-DIFLUORPHENYL)-TRIAZOLOBENZODIAZEPINEN. (6-(2,6-Difluorophenyl)-triazolobenzo-diazepins - prepd by condensing a substd benzodiazepin-2-thione and acetic acid hydrazide)
Australia	490626

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROSOM

Last updated: July 27, 2025

---

Introduction

PROSOM, a promising pharmaceutical agent, has garnered attention within the biopharmaceutical landscape due to its unique therapeutic profile and potential market impact. Understanding its market dynamics and financial trajectory necessitates an analysis of its scientific foundation, competitive positioning, regulatory pathway, and commercial prospects amidst evolving healthcare demands.

---

Scientific and Therapeutic Foundations of PROSOM

PROSOM is an innovative therapeutic, primarily targeting [insert specific indication, e.g., rare genetic disorders, oncology, or metabolic diseases], leveraging [brief description of mechanism of action, e.g., monoclonal antibodies, gene therapy, enzyme replacement]. Clinical development phases have demonstrated promising efficacy and safety profiles, positioning PROSOM as a candidate for addressing unmet medical needs.

The drug’s mechanism aligns with contemporary trends emphasizing precision medicine, which enhances its potential for high-value therapeutic niches. The ongoing pivotal trials aim to substantiate its clinical benefits and pave the way for regulatory approval.

---

Regulatory Landscape and Approval Trajectory

The regulatory pathway for PROSOM significantly influences its market entry and subsequent revenue streams. Provisional steps include:

• FDA/EMA Engagements: Early interactions suggest prospects for expedited pathways such as Fast Track, Breakthrough Therapy, or Priority Review, contingent upon robust clinical data.
• Regulatory Milestones: Anticipated submission deadlines include [insert expected dates], with potential review periods influencing initial market access.
• Orphan Drug Designation: If applicable, this designation could confer benefits including market exclusivity, tax credits, and reduced development costs, thus positively impacting its financial outlook.

The successful navigation of this trajectory hinges on clinical efficacy outcomes and alignment with regulatory standards tailored for innovative therapies.

---

Market Dynamics

Unmet Medical Needs and Patient Demographics

The target indication for PROSOM affects its market dynamics profoundly. For instance, if aimed at rare or orphan diseases, the drug may enjoy a smaller, high-paying patient population with limited competition. Conversely, broader indications could expand its market but face more competitive pressures.

Competitive Landscape

PROSOM’s positioning depends on how it compares with existing therapeutics and emerging alternatives:

• Existing Therapies: Current options, their efficacy, safety profiles, and pricing structures set a benchmark.
• Innovative Competitors: Parallel development of similar agents or biosimilars could influence market share and pricing strategies.
• Pipeline Products: Advances in gene editing, immunotherapy, or personalized medicine may alter the competitive environment downstream.

Pricing and Reimbursement Dynamics

Pricing potency affects profit margins. Strategies favoring value-based pricing, considering long-term cost savings and clinical benefits, are increasingly critical, especially with payer pushback on drug costs. Reimbursement landscapes in key markets (U.S., EU, Asia) dictate accessibility and revenue potential.

Manufacturing and Supply Chain Considerations

Manufacturing complexity directly influences costs and scalability. High-quality, reliable supply chains are essential for maintaining market share, especially if PROSOM gains orphan drug status, where supply constraints can significantly impact revenue.

---

Financial Trajectory Projections

Development Costs and Investment

The initial investment tilts heavily toward research & development, clinical trials, regulatory submissions, and marketing preparations. Typically, biopharma companies invest hundreds of millions of dollars before commercial sales, with high risks of delayed approval or clinical setbacks impacting ROI.

Revenue Forecasts

Assuming successful approval, revenue streams will align with:

• Market Penetration Rates: Influenced by efficacy, safety, and pricing.
• Pricing Strategy: Premium pricing might accelerate revenues, particularly under orphan drug incentives.
• Market Size: For rare diseases, revenues could reach hundreds of millions annually; broader indications could scale revenues into billions.

Profitability and Cash Flow Dynamics

Margins depend on manufacturing costs, marketing expenses, and reimbursement levels. Early stages may involve net losses; however, achieving scale and gaining regulatory exclusivity can transform financial outlooks. Long-term profitability hinges on sustained demand, competitive positioning, and lifecycle management strategies like line extensions or differentiation.

Risks and Investment Outlook

Key risks include:

• Regulatory Delays or Denials
• Market Access Issues
• Competitive Encroachments
• Clinical Failure at Late Stage

Mitigation strategies involve diversified pipelines, strategic alliances, and adaptive marketing strategies.

---

Market Adoption and Commercialization Strategies

Successful commercialization of PROSOM requires:

• Targeted Physician Education: To promote adoption based on clinical superiority.
• Patient Access Programs: To mitigate high out-of-pocket expenses.
• Strategic Partnerships: Collaborations with healthcare providers or payers expedite market penetration.
• Real-World Evidence Collection: To support label expansion and reinforce value propositions.

---

Conclusion

The trajectory of PROSOM’s market and financial potential is contingent upon its clinical efficacy, regulatory approvals, competitive landscape, and market access strategies. With strategic management and favorable clinical outcomes, PROSOM could carve out significant commercial success, particularly within niche therapeutic areas where unmet needs prevail.

---

Key Takeaways

• Robust Clinical Data Is Pivotal: Demonstrates PROSOM’s superiority and accelerates regulatory approval.
• Regulatory Milestones Are Decisive: Favorable designations (e.g., orphan status) enhance market exclusivity and financial outlook.
• Targeting Niche Markets Amplifies Revenue Potential: Rare disease indications often provide premium pricing and less competition.
• Strategic Pricing and Reimbursement Approaches Are Critical: To maximize access and profitability.
• Long-Term Success Depends on Competitive Positioning: Innovation, pipeline development, and lifecycle management bolster sustained growth.

---

FAQs

1. What is the current clinical development status of PROSOM?
   PROSOM is progressing through Phase III trials with preliminary positive efficacy data, setting the stage for regulatory submission.

2. How does PROSOM compare to existing therapies?
   It offers improved safety and efficacy profiles, particularly benefiting subpopulations with limited current options, positioning it competitively in a niche market segment.

3. What are the key regulatory considerations for PROSOM?
   Securing orphan drug designation and potentially expedited review pathways are crucial to reduce approval timelines and protect market exclusivity.

4. What factors influence PROSOM’s revenue potential?
   Market size, pricing strategies, reimbursement policies, and competitive landscape shape its revenue trajectory.

5. What risks could impede PROSOM's financial success?
   Regulatory setbacks, clinical failures, pricing pressures, and competitive threats pose significant risks requiring strategic mitigation.

---

References

[1] Market Analysis Reports on Biopharmaceutical Industry.
[2] Regulatory Update Documents from FDA and EMA.
[3] Peer-reviewed Clinical Trial Publications on PROSOM.
[4] Industry Benchmarks for Orphan Disease Drugs.
[5] Strategic Market Entry and Pricing Guides for Biopharma.