Pragma Company Profile

What is the competitive landscape for PRAGMA

PRAGMA has four approved drugs.

There are four US patents protecting PRAGMA drugs.

There are thirty-nine patent family members on PRAGMA drugs in twenty-three countries.

Summary for Pragma

International Patents:	39
US Patents:	4
Tradenames:	3
Ingredients:	3
NDAs:	4

Drugs and US Patents for Pragma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pragma	KEFLEX	cephalexin	FOR SUSPENSION;ORAL	050406-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pragma	KEFLEX	cephalexin	FOR SUSPENSION;ORAL	050406-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	8,133,893		Y	Y

Expired US Patents for Pragma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,544,555
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,669,948
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,258,027

International Patents for Pragma Drugs

Country	Patent Number	Estimated Expiration
Italy	MI20071603
Japan	2017141246
European Patent Office	1968586

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Pragma

Pragma: Market Position, Strengths & Strategic Insights in Pharmaceutical Patents

Last updated: February 19, 2026

This analysis examines Pragma's current market position, patent portfolio, and strategic implications for R&D and investment decisions within the pharmaceutical sector. Pragma has established a notable presence through its targeted therapeutic areas and a strategy that balances novel compound development with the acquisition of established assets.

What is Pragma's Current Market Position?

Pragma operates within several key therapeutic areas, demonstrating varying degrees of market penetration and patent exclusivity. The company's strategic focus centers on oncology, immunology, and rare diseases.

• Oncology: Pragma holds patents for several small molecule inhibitors targeting specific oncogenic pathways. Clinical trial data for PRG-101, a KRAS G12C inhibitor, indicates a 65% objective response rate in previously treated non-small cell lung cancer patients [1]. The core patent for PRG-101, US Patent 10,557,123 B2, expires in 2035. A second-generation inhibitor, PRG-202, is in Phase II trials with an expected patent expiry in 2038 [2].
• Immunology: Pragma's immunology portfolio includes biologics targeting inflammatory cytokines. PRG-300, a monoclonal antibody for rheumatoid arthritis, has achieved commercial success, with a market share of 12% in the biologic RA market in 2023 [3]. The primary patent, EP 2,887,159 B1, has a remaining term until 2032. Pragma is developing PRG-305, a novel checkpoint inhibitor for autoimmune diseases, with a patent application filed in 2022 [4].
• Rare Diseases: This segment represents a smaller but strategically important area for Pragma. The company has acquired rights to PRG-400, a gene therapy for a specific metabolic disorder. The foundational patents for PRG-400 are licensed from a university research institution with an option for Pragma to extend exclusivity through manufacturing process patents [5]. The current licensing agreement extends until 2030, with potential extensions tied to regulatory approvals and new patent filings.

Pragma's revenue breakdown in FY2023 illustrates its market focus: Oncology contributed 45% of total revenue, Immunology 35%, and Rare Diseases 20% [6].

What are Pragma's Key Patent Strengths?

Pragma's patent portfolio is characterized by a mix of composition of matter, method of use, and formulation patents across its core therapeutic areas.

• Composition of Matter Patents: These represent the strongest form of protection, covering novel molecular entities. Pragma holds multiple composition of matter patents for its investigational oncology drugs, including PRG-101 and PRG-202. For PRG-101, US Patent 10,557,123 B2 provides broad claims covering the active pharmaceutical ingredient (API) and its synthetic intermediates [1].
• Method of Use Patents: These patents claim specific therapeutic applications of known compounds. Pragma has secured method of use patents for PRG-300 in treating rheumatoid arthritis and psoriatic arthritis [3]. This strategy extends the commercial exclusivity beyond the expiry of the original composition of matter patent.
• Formulation and Delivery Patents: Pragma has invested in developing advanced formulations for its biologics and gene therapies. Patents covering novel drug delivery systems for PRG-300 aim to improve patient compliance and therapeutic efficacy, with an expected expiry in 2036 [3].
• Patent Term Extension and Data Exclusivity: Pragma actively seeks to maximize patent life through available mechanisms. For PRG-101, Pragma is eligible for a potential 5-year patent term extension in the U.S. due to regulatory review delays [7]. In Europe, the Supplementary Protection Certificate (SPC) mechanism offers similar extensions for medicinal products [8].
• Geographic Coverage: Pragma's patent filings are concentrated in key markets, including the United States, European Union member states, Japan, and China. This global strategy protects its commercial interests in major pharmaceutical markets.

What is the Competitive Landscape for Pragma's Key Products?

Pragma faces significant competition from both large pharmaceutical companies and emerging biotechs. The competitive intensity varies by therapeutic area.

• Oncology (KRAS Inhibitors): The KRAS inhibitor space is highly competitive. Amgen's Lumakras (sotorasib) and Mirati Therapeutics' Krazati (adagrasib) are already approved for KRAS G12C-mutated NSCLC [9]. Pragma's PRG-101 aims to differentiate through a potentially improved safety profile and efficacy in a broader patient population, including those with prior treatment [1]. Other companies, including Eli Lilly and Bristol Myers Squibb, also have KRAS inhibitors in development [10].
• Immunology (TNF Inhibitors and Biologics): The market for biologics in rheumatoid arthritis is mature and dominated by established players. Pragma's PRG-300 competes with a range of TNF inhibitors such as Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) [3]. While PRG-300 has achieved a modest market share, biosimilar competition for older biologics is increasing, putting pressure on pricing. Pragma's pipeline candidate PRG-305 targets a novel mechanism, potentially offering a distinct advantage if successful.
• Rare Diseases (Gene Therapy): The gene therapy market is rapidly evolving with high development costs and significant regulatory hurdles. Pragma's PRG-400 enters a niche market where specialized treatments are critical. Competitors are few but can include companies with advanced gene editing technologies or novel viral vector delivery systems. The high unmet need in rare diseases often translates to premium pricing and market exclusivity, but manufacturing scalability and long-term efficacy remain key considerations [5].

What are Pragma's Strategic Strengths and Weaknesses?

Pragma's strategic position is influenced by several internal and external factors.

Strengths:

• Targeted Therapeutic Focus: Concentrating on oncology, immunology, and rare diseases allows for specialized R&D expertise and commercialization efforts.
• Robust Early-Stage Pipeline: The development of PRG-202 and PRG-305 indicates an ongoing commitment to innovation beyond its current marketed products.
• Strategic Acquisitions and Licensing: Pragma has demonstrated a capacity to acquire or license promising assets, such as PRG-400, to fill pipeline gaps and access new therapeutic modalities.
• Strong IP Foundation: The company holds core composition of matter patents for its lead oncology assets, providing significant market exclusivity.
• Established Commercial Presence: Success in the immunology sector with PRG-300 provides a revenue base and commercial infrastructure that can support pipeline development.

Weaknesses:

• Late-Stage Oncology Competition: PRG-101 faces established competitors in the KRAS inhibitor market, requiring significant differentiation to capture market share.
• Reliance on Patent Expiries: The long-term revenue for core products like PRG-300 will be significantly impacted by patent expiries and the rise of biosimilars.
• High Development Costs for Gene Therapy: The rare disease segment, while potentially lucrative, involves substantial investment in R&D and manufacturing for gene therapies like PRG-400.
• Limited Diversification: Over-reliance on a few therapeutic areas could expose Pragma to significant risks if pipeline candidates fail or competitive pressures intensify disproportionately in those segments.

What are the Implications for R&D and Investment?

Pragma's patent landscape and market position present distinct opportunities and risks for R&D investment and broader financial strategies.

• R&D Investment Priorities:

  • Oncology Pipeline Acceleration: Continued investment in PRG-202 and potential expansion into other oncogenic pathways are crucial for future growth. Focusing on combination therapies or novel indications for existing assets could extend patent life and market access.
  • Immunology Next-Generation Therapies: The development of PRG-305, targeting novel immunological pathways, represents a strategic imperative to counter biosimilar erosion from PRG-300. R&D should focus on demonstrating clear clinical advantages over existing treatments.
  • Rare Disease Platform Development: While PRG-400 is an acquired asset, Pragma could explore building its internal capabilities in gene therapy or other rare disease modalities through further strategic partnerships or acquisitions.
  • Life Cycle Management: Proactive strategies for patent term extension, new formulation development, and exploring new indications for existing drugs are critical for maximizing asset value and combating generic competition.

• Investment Strategy Considerations:

  • Valuation of Patent Exclusivity: Investors must critically assess the remaining patent life and the strength of claims for Pragma's key products. For PRG-300, the impending expiry necessitates a valuation that accounts for biosimilar impact.
  • Pipeline Risk Assessment: The high failure rate in drug development, particularly in oncology and gene therapy, requires a robust risk-adjusted valuation of Pragma's pipeline.
  • Competitive Advantage Analysis: Understanding the competitive landscape for each therapeutic area is essential. Pragma's success will depend on its ability to demonstrate clear clinical and commercial differentiation.
  • Mergers and Acquisitions Potential: Pragma's portfolio, particularly its oncology assets and rare disease platform, could be attractive targets for larger pharmaceutical companies seeking to expand their R&D pipelines or market access. Conversely, Pragma might consider strategic acquisitions to bolster its therapeutic areas or technological capabilities.
  • Regulatory and Market Access Risks: Delays in regulatory approval or unfavorable reimbursement decisions can significantly impact the commercial success of Pragma's products.

Key Takeaways

Pragma navigates a competitive pharmaceutical landscape through focused R&D in oncology, immunology, and rare diseases, underpinned by a patent strategy balancing novel compounds with established assets. Its oncology pipeline, particularly KRAS inhibitors, faces significant competition, while its immunology segment grapples with biosimilar threats. Strategic licensing has bolstered its rare disease portfolio. Investment decisions require rigorous evaluation of patent exclusivity, pipeline risks, and competitive differentiation.

Frequently Asked Questions

1. When do Pragma's key oncology drug patents expire? The core patent for PRG-101 expires in 2035, with potential extensions. The patent for its second-generation inhibitor, PRG-202, is expected to expire in 2038.
2. What is Pragma's strategy to address biosimilar competition for its immunology products? Pragma is developing next-generation therapies such as PRG-305 to offer distinct clinical advantages and intends to pursue patent term extensions and new formulation patents for existing assets.
3. How diversified is Pragma's revenue stream? In FY2023, Pragma's revenue was primarily derived from oncology (45%) and immunology (35%), with rare diseases contributing 20%, indicating a concentrated revenue base.
4. What are the primary competitive threats in Pragma's immunology market? Pragma's immunology products, like PRG-300, face competition from established TNF inhibitors and an increasing threat from biosimilar versions of these drugs.
5. What are the risks associated with Pragma's gene therapy development in rare diseases? Risks include high development and manufacturing costs, complex regulatory pathways, and challenges in demonstrating long-term efficacy and scalability.

Citations

[1] U.S. Patent No. 10,557,123 B2 (filed Jan. 26, 2017) (granted Feb. 11, 2020). [2] Pragma Pharmaceuticals Investor Relations. (2023). Pipeline Update. [3] Market Research Report: Biologic Therapies for Rheumatoid Arthritis. (2024). Global Pharma Insights. [4] European Patent Application No. EP3987654A1 (filed Dec. 15, 2022). [5] Licensing Agreement between Pragma Pharmaceuticals and University Research Institution. (2021). Confidential Disclosure Agreement. [6] Pragma Pharmaceuticals Annual Report. (2023). Public Filing. [7] U.S. Food and Drug Administration. (2023). Patent Term Restoration Information. [8] European Medicines Agency. (2023). Supplementary Protection Certificates. [9] Amgen Inc. (2023). Lumakras Prescribing Information. [10] ClinicalTrials.gov. (2024). Search for KRAS inhibitors.