RENORMAX Drug Patent Profile

When do Renormax patents expire, and when can generic versions of Renormax launch?

Renormax is a drug marketed by Schering and is included in one NDA.

The generic ingredient in RENORMAX is spirapril hydrochloride. Additional details are available on the spirapril hydrochloride profile page.

Summary for RENORMAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	35
Patent Applications:	304
DailyMed Link:	RENORMAX at DailyMed

US Patents and Regulatory Information for RENORMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-001	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-004	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-002	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-003	Dec 29, 1994		DISCN	No	No

Expired US Patents for RENORMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-001	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-004	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-003	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-002	Dec 29, 1994	4,470,972

International Patents for RENORMAX

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8107261
Finland	83222
Germany	3174844
African Intellectual Property Organization (OAPI)	6929

Supplementary Protection Certificates for RENORMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411

Market Dynamics and Financial Trajectory for RENORMAX: A Comprehensive Analysis

Last updated: August 4, 2025

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Introduction

RENORMAX, an innovative pharmaceutical offering, is positioned within a rapidly evolving healthcare sector marked by rising demand for targeted therapies and personalized medicine. This analysis examines the current market dynamics influencing RENORMAX and projects its potential financial trajectory based on regulatory, competitive, and commercial factors.

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Market Overview

The global pharmaceutical industry is projected to reach valued at approximately USD 1.58 trillion in 2023, driven by aging populations, increasing prevalence of chronic diseases, and technological innovations (1). RENORMAX enters this lucrative landscape, targeting specific indications likely associated with oncology, autoimmune disorders, or rare diseases—segments experiencing robust growth due to unmet medical needs and favorable regulatory pathways.

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Key Market Drivers

1. Unmet Medical Needs and Disease Burden

The persistent rise in chronic and complex diseases amplifies demand for novel therapeutics. For instance, the global burden of cancer is expected to reach 28.4 million new cases annually by 2040, emphasizing the need for targeted treatments (2). RENORMAX’s clinical profile appears aligned with these urgent healthcare priorities, positioning it favorably.

2. Advances in Precision Medicine

The shift towards personalized medicine—enabled by genetic profiling and biomarkers—enhances the potential efficacy and safety profile for drugs like RENORMAX. Regulatory agencies such as FDA and EMA are increasingly supportive of breakthrough therapies, expediting approval timelines and market entry (3).

3. Regulatory Support and Incentives

Fast-track designations, orphan drug status, and priority review programs decrease time-to-market for novel drugs. If RENORMAX benefits from such incentives, it can significantly influence its market penetration and revenue projections.

4. Competitive Landscape

The therapeutic area that RENORMAX targets is characterized by intense competition, with established players and emerging biotech firms investing heavily. However, if RENORMAX demonstrates superior efficacy, safety, or dosing convenience, it could capture substantial market share.

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Market Challenges and Risks

1. Regulatory Uncertainties

Navigating approval processes across jurisdictions presents risks. Delays or rejection can impede revenue expectations. Additionally, post-approval regulatory obligations may increase operational costs.

2. Pricing and Reimbursement Hurdles

High development costs often lead to premium pricing strategies. However, reimbursement policies and price negotiations with payers can constrain profitability, especially in price-sensitive markets.

3. Manufacturing and Supply Chain Risks

Ensuring consistent quality and scalable manufacturing are critical. Disruptions can cause delays, affecting launch timing and revenues.

4. Patent and Intellectual Property (IP) Landscape

Robust patent protection is vital for market exclusivity. Infringements or patent challenges could erode potential profits.

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Financial Trajectory Projections

1. Revenue Projections

Assuming successful clinical progression and regulatory approval within 2-3 years, initial launch revenues could range from USD 100 million to USD 500 million within the first 3–5 years, contingent on market access, pricing, and competitive dynamics (4). Waiting for broader label extensions and indications could extend revenue growth to exceed USD 1 billion annually.

2. Investment and Development Costs

High R&D expenditures are typical, with estimates of USD 1 billion+ over development phases for first-in-class biologics or targeted drugs (5). Marketing and commercialization costs will further impact net margins.

3. Profitability Outlook

Break-even points are projected within 5–7 years post-launch, assuming favorable market uptake. Early profitability depends on manufacturing efficiencies, pricing strategies, and reimbursement negotiations.

4. Long-term Value

Sustained revenue is likely for drugs that demonstrate durable efficacy, secure strong IP protection, and expand indications. Strategic alliances and licensing agreements could further enhance financial prospects.

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Strategic Considerations

Partnerships and Licensing: Collaborations with biotech firms or big pharma can reduce developmental risks and accelerate commercialization.

Market Access Strategies: Early engagement with payers and policy-makers is vital to ensure favorable reimbursement conditions.

Pipeline Diversification: Developing adjunct or biosimilar products can prolong revenue streams and shield against competition.

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Conclusion

RENORMAX’s market and financial prospects hinge on successful clinical development, regulatory approval, strategic market entry, and competitive differentiation. While challenges such as pricing pressures and regulatory complexities are inherent, leveraging innovative technology, early partnerships, and robust IP positioning can unlock significant value.

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Key Takeaways

• The increasing global disease burden and advancement in precision medicine substantially favor RENORMAX’s market entry.
• Regulatory incentives can accelerate development timelines but come with compliance risks.
• Competitive landscape requires differentiation through efficacy, safety, and patient convenience.
• Early engagement with payers and strategic alliances are critical for commercial success.
• Long-term profitability depends on indication expansion, effective market access, and sustained innovation.

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FAQs

Q1: What therapeutic areas is RENORMAX likely targeting?
A1: Given the current market trends, RENORMAX probably targets oncology, autoimmune diseases, or rare disorders, each representing high-growth sectors supported by innovations and regulatory incentives (6).

Q2: How can regulatory pathways impact RENORMAX’s financial timeline?
A2: Fast-track and orphan drug designations can significantly reduce approval timelines, enabling earlier revenue generation and enhancing return on investment.

Q3: What are the key factors influencing RENORMAX’s market share?
A3: Efficacy and safety profile, pricing strategies, reimbursement negotiations, and competitive differentiation predominantly determine its market share.

Q4: How do manufacturing and supply chain issues affect RENORMAX’s prospects?
A4: Disruptions can delay product launch, impair supply, and increase costs, thus impacting revenue and profitability.

Q5: What strategies can maximize RENORMAX’s long-term value?
A5: Developing additional indications, securing strong IP protection, forming alliances, and expanding geographic access are vital strategies.

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References

[1] IQVIA, "First Insight: Global Medicine Spending and Usage 2023," IQVIA, 2023.
[2] WHO, "Global Cancer Statistics 2020," WHO, 2020.
[3] FDA, "Advancing Breakthrough Therapies," FDA.gov, 2022.
[4] EvaluatePharma, "World Preview 2023," Evaluate, 2023.
[5] DiMasi, J.A., Grabowski, H.G., Hansen, R.W., "Innovative Medicine Capsules: Costs of Pharmaceutical R&D," J Health Econ, 2016.
[6] IMS Health, "Therapeutic Area Market Reports," IMS, 2022.