You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

POTASSIUM AMINOSALICYLATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for potassium aminosalicylate and what is the scope of freedom to operate?

Potassium aminosalicylate is the generic ingredient in two branded drugs marketed by Glenwood and Hexcel, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for POTASSIUM AMINOSALICYLATE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 24
Patent Applications: 15
DailyMed Link:POTASSIUM AMINOSALICYLATE at DailyMed

US Patents and Regulatory Information for POTASSIUM AMINOSALICYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenwood PASKALIUM potassium aminosalicylate CAPSULE;ORAL 009395-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hexcel POTASSIUM AMINOSALICYLATE potassium aminosalicylate POWDER;ORAL 080098-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glenwood PASKALIUM potassium aminosalicylate TABLET;ORAL 009395-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Potassium Aminosalicylate (PAS)

Last updated: February 8, 2026

Potassium aminosalicylate, an oral antitubercular agent, is primarily used for the treatment of active tuberculosis. Its market is influenced by global tuberculosis prevalence, existing treatment protocols, drug resistance patterns, and regulatory environments.

Market Overview

The global tuberculosis treatment market was valued at approximately USD 1.46 billion in 2020, with an expected compound annual growth rate (CAGR) of 4.3% from 2021 to 2028 [1]. Potassium aminosalicylate constitutes a niche segment within this market, predominantly supplied as part of multi-drug regimens in fixed-dose combinations (FDCs).

Key Market Drivers

  1. Global Tuberculosis Burden: The World Health Organization (WHO) reports about 10 million new TB cases annually, with rising drug-resistant strains increasing reliance on second-line agents like PAS [2].

  2. Treatment Guidelines: WHO recommends PAS as part of the longer, second-line treatment regimens for multidrug-resistant TB (MDR-TB). These authorizations support consistent demand.

  3. Regulatory Approvals & Patent Status: PAS is formulated under multiple generic products; patent expirations have increased manufacturing competition, stabilizing prices and expanding market access.

Market Challenges

  1. Drug Resistance: Increasing resistance to first-line drugs reduces the preference for PAS, complicating its market growth prospects [3].

  2. Side-Effect Profile: PAS can cause adverse effects like gastrointestinal toxicity and hepatotoxicity, which can limit patient tolerance and adherence, affecting demand.

  3. Market Competition: The availability of newer, more efficacious second-line drugs, coupled with the rise of long-acting injectables, diminishes reliance on oral PAS.

Financial Trajectory Predictions

The revenue contribution of potassium aminosalicylate is projected to expand modestly, driven by global MDR-TB control efforts. Based on current market size estimates (approx. USD 300 million in 2022 for the entire second-line agent segment), PAS-specific sales are approximately USD 50-70 million.

Projected growth considers:

  • Increased MDR-TB Cases: Global MDR-TB incidences are projected to reach 3.3 million cases by 2030 [4], creating steady demand for second-line treatments, including PAS.

  • Generic Market Expansion: With patent expirations, especially in emerging markets like India and China, generic supplies will further drive volume sales.

  • Global Health Initiatives: Funding from Gavi and the Global Fund supports procurement, maintaining a steady demand baseline.

However, patent corridors and recent market shifts imply that the financial trajectory may see stable or slight decline unless new formulations or combination products increase utilization.

Regulatory and Policy Impact

The WHO End TB Strategy aims for a 20% reduction in TB incidence by 2025 and aims for universal access to TB medicines. While these policies support overall market stability, they emphasize shorter, more tolerable treatments, potentially reducing long-term demand for PAS.

Competitive Landscape

Major manufacturers include AstraZeneca (historical), and several Indian and Chinese generics producers. Increased competition has led to price reductions, affecting profit margins but enlarging accessibility.

Market Forecast Summary

Metric 2022 2028 (Projection)
Market size for PAS-specific drugs USD 50-70 million USD 55-75 million (modest growth)
CAGR 1.5%–2.0% 1.5%–2.0%
Key growth factors MDR-TB prevalence, generic expansion Global health funding, market saturation

Key Takeaways

  • The market for potassium aminosalicylate remains niche but stable, driven mainly by MDR-TB treatment needs.
  • Growth is constrained by drug resistance development, treatment evolution, and market competition.
  • Price pressure from generics and reforms toward shorter regimens limit revenue expansion.
  • Increasing TB prevalence and global efforts ensure sustained demand in specific regions.
  • Future growth hinges on novel formulations, combination therapies, and improved tolerability.

FAQs

1. Why is potassium aminosalicylate used in TB treatments?
It acts as a second-line agent effective against MDR-TB, placed as part of combination therapies to combat resistant strains.

2. How does resistance impact the PAS market?
Growing resistance to first-line drugs shifts treatment toward second-line agents like PAS, but emerging resistance to second-line drugs can reduce its effectiveness and market size.

3. Are there new formulations of PAS under development?
No significant new formulations have been approved recently. Focus is on combination therapies and improving tolerability of existing drugs.

4. How do patent expirations influence PAS’s market?
Patent expirations enable generic manufacturers to produce lower-cost versions, expanding access but eroding profit margins for established players.

5. What are the prospects for PAS in non-tuberculosis indications?
Currently, PAS’s primary indication remains TB, with limited exploration into alternative uses.


References

[1] Transparency Market Research, "Global Tuberculosis Treatment Market," 2021.
[2] WHO, "Global Tuberculosis Report," 2022.
[3] CDC, "Drug-Resistant TB," 2021.
[4] Stop TB Partnership, "Global MDR-TB estimates," 2020.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.