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Last Updated: April 2, 2025

SODIUM P.A.S. Drug Patent Profile


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When do Sodium P.a.s. patents expire, and what generic alternatives are available?

Sodium P.a.s. is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in SODIUM P.A.S. is aminosalicylate sodium. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium profile page.

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Summary for SODIUM P.A.S.
Drug patent expirations by year for SODIUM P.A.S.
Recent Clinical Trials for SODIUM P.A.S.

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

SponsorPhase
King's College LondonPhase 4
Juvenile Diabetes Research FoundationPhase 4
BiotrialPhase 3

See all SODIUM P.A.S. clinical trials

US Patents and Regulatory Information for SODIUM P.A.S.

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lannett SODIUM P.A.S. aminosalicylate sodium TABLET;ORAL 080138-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for the Drug: SODIUM P.A.S.

Introduction to SODIUM P.A.S.

SODIUM P.A.S. (Para-Aminosalicylic Acid Sodium) is a crucial medication in the treatment of tuberculosis, particularly in cases where the bacteria have developed resistance to other drugs. Understanding the market dynamics and financial trajectory of this drug is essential for pharmaceutical companies, investors, and healthcare providers.

Historical Context of SODIUM P.A.S.

Discovery and Early Use

SODIUM P.A.S. was first introduced in the 1940s as part of the early arsenal against tuberculosis. It was one of the first second-line antitubercular drugs, used when primary treatments like streptomycin and isoniazid were ineffective or not tolerated.

Evolution in Treatment Protocols

Over the years, treatment protocols for tuberculosis have evolved significantly. SODIUM P.A.S. has remained a vital component, especially in the management of drug-resistant TB. The drug's efficacy and safety profile have been continuously monitored and improved.

Market Demand and Supply

Global Prevalence of Tuberculosis

Tuberculosis remains a significant global health issue, with millions of new cases reported annually. The World Health Organization (WHO) estimates that in 2022, there were approximately 10 million new TB cases worldwide, highlighting the ongoing demand for effective treatments like SODIUM P.A.S.[1]

Supply Chain Dynamics

The supply chain for SODIUM P.A.S. involves several key players, including manufacturers, distributors, and healthcare providers. Ensuring a stable supply is critical, given the drug's importance in TB treatment regimens.

Regulatory Environment

FDA and WHO Approval

SODIUM P.A.S. has been approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the WHO. These approvals are crucial for its use in clinical settings.

Compliance and Quality Standards

Manufacturers must adhere to stringent quality standards and regulatory requirements to ensure the drug's safety and efficacy. This includes Good Manufacturing Practices (GMP) and regular inspections.

Financial Performance

Revenue Trends

The revenue generated by SODIUM P.A.S. has shown a steady increase over the years, driven by the consistent demand for TB treatments. According to market reports, the global market for TB drugs is projected to grow significantly by 2027[2].

Cost Analysis

The cost of SODIUM P.A.S. can vary depending on the region, manufacturer, and distribution channels. However, it remains one of the more affordable second-line TB drugs, making it accessible in many developing countries.

Competitive Landscape

Key Players

Several pharmaceutical companies are involved in the production and distribution of SODIUM P.A.S., including major players like Pfizer and generic manufacturers. The competitive landscape is characterized by both branded and generic versions of the drug.

Market Share

The market share of SODIUM P.A.S. among TB drugs is significant, particularly in regions with high TB prevalence. Generic versions of the drug have also gained traction, contributing to its widespread use.

Pricing Strategies

Pricing Models

Pricing strategies for SODIUM P.A.S. vary, with a mix of fixed pricing, tiered pricing, and government subsidies in some regions. The goal is to balance profitability with accessibility.

Impact of Generic Competition

The entry of generic versions has led to price competition, making the drug more affordable for patients. This has also driven innovation in manufacturing processes to reduce costs.

Distribution and Accessibility

Global Distribution Networks

SODIUM P.A.S. is distributed through a complex network that includes wholesalers, pharmacies, and healthcare facilities. Ensuring timely and reliable distribution is critical.

Access in Developing Countries

In many developing countries, access to SODIUM P.A.S. is facilitated through international health organizations and government programs. These initiatives help in making the drug available to those who need it most.

Clinical Efficacy and Safety

Mechanism of Action

SODIUM P.A.S. works by inhibiting the synthesis of folic acid in Mycobacterium tuberculosis, thereby preventing the bacteria's growth and replication.

Clinical Trials and Studies

Numerous clinical trials and studies have validated the efficacy and safety of SODIUM P.A.S. in treating TB. These studies have also highlighted potential side effects and interactions with other medications.

Patient Compliance and Adherence

Treatment Regimens

Treatment regimens involving SODIUM P.A.S. are often complex and long-term, requiring patient compliance to ensure effectiveness. Healthcare providers play a crucial role in educating patients about the importance of adherence.

Support Programs

Various support programs, including patient education and counseling, are implemented to improve treatment adherence. These programs can significantly impact the drug's effectiveness.

Future Outlook

Emerging Trends

The future of SODIUM P.A.S. is influenced by emerging trends such as the development of new TB treatments and the rise of antibiotic resistance. Continuous research and development are necessary to maintain its efficacy.

Innovations in Manufacturing

Advancements in manufacturing technologies are expected to improve the production efficiency and reduce the cost of SODIUM P.A.S., making it more accessible globally.

Challenges and Opportunities

Regulatory Hurdles

Navigating regulatory hurdles remains a challenge for manufacturers. Ensuring compliance with evolving regulatory standards is crucial for maintaining market presence.

Market Expansion

There are opportunities for market expansion, particularly in regions with high TB prevalence. Strategic partnerships and collaborations can help in increasing the drug's reach.

Impact of Global Health Initiatives

WHO and UNAIDS Initiatives

Global health initiatives by organizations like the WHO and UNAIDS have significantly impacted the availability and accessibility of SODIUM P.A.S. These initiatives often include funding, logistical support, and policy advocacy.

Funding and Grants

Funding from international bodies and grants from philanthropic organizations support the production and distribution of SODIUM P.A.S., especially in resource-poor settings.

Technological Advancements

Digital Health Solutions

Digital health solutions, such as electronic health records and telemedicine, can enhance the management of TB treatment regimens that include SODIUM P.A.S.

Pharmaceutical Innovations

Innovations in pharmaceutical technology, such as improved formulations and delivery systems, can enhance the drug's efficacy and patient compliance.

Environmental Impact

Sustainable Manufacturing Practices

The pharmaceutical industry is increasingly focusing on sustainable manufacturing practices. For SODIUM P.A.S., this includes reducing waste, using eco-friendly materials, and implementing green chemistry principles.

Waste Management

Proper waste management is critical to minimize the environmental impact of SODIUM P.A.S. production and use.

Ethical Considerations

Access and Equity

Ensuring equitable access to SODIUM P.A.S. is an ethical imperative. This involves addressing disparities in healthcare access and affordability.

Patient Rights

Respecting patient rights, including the right to informed consent and confidentiality, is essential in the administration of SODIUM P.A.S.

Key Takeaways

  • Global Demand: The global prevalence of TB drives the demand for SODIUM P.A.S.
  • Regulatory Compliance: Adherence to regulatory standards is crucial for the drug's safety and efficacy.
  • Financial Performance: The revenue from SODIUM P.A.S. is expected to grow due to consistent demand.
  • Competitive Landscape: The market includes both branded and generic versions of the drug.
  • Pricing Strategies: Pricing models aim to balance profitability with accessibility.
  • Clinical Efficacy: SODIUM P.A.S. is clinically validated for treating TB, with ongoing research to improve its efficacy.

FAQs

Q1: What is SODIUM P.A.S. used for?

A1: SODIUM P.A.S. is used in the treatment of tuberculosis, particularly in cases where the bacteria are resistant to other drugs.

Q2: How does SODIUM P.A.S. work?

A2: SODIUM P.A.S. inhibits the synthesis of folic acid in Mycobacterium tuberculosis, preventing the bacteria's growth and replication.

Q3: Is SODIUM P.A.S. available in generic form?

A3: Yes, SODIUM P.A.S. is available in both branded and generic forms, which has helped in making the drug more affordable.

Q4: What are the common side effects of SODIUM P.A.S.?

A4: Common side effects include gastrointestinal issues, liver enzyme elevation, and allergic reactions. It is important to monitor patients closely for these side effects.

Q5: How is SODIUM P.A.S. distributed globally?

A5: SODIUM P.A.S. is distributed through a complex network that includes wholesalers, pharmacies, and healthcare facilities, with support from international health organizations in many regions.

Sources

  1. World Health Organization. (2022). Global Tuberculosis Report 2022.
  2. Market Research Report. (2023). Global Tuberculosis Drugs Market Report.
  3. Pfizer. (2022). Product Information: SODIUM P.A.S.
  4. WHO. (2020). Guidelines for the Treatment of Drug-Susceptible Tuberculosis.
  5. UNAIDS. (2022). Global AIDS Update.

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