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Last Updated: April 18, 2025

Drugs in MeSH Category Antitubercular Agents


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genus ISONIAZID isoniazid TABLET;ORAL 080937-002 Approved Prior to Jan 1, 1982 AA RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma Intl Pharms ISONIAZID isoniazid TABLET;ORAL 080212-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lupin ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939-001 Jun 17, 2009 AB RX 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

Antitubercular Agents Market Analysis and Financial Projection

The global market for antitubercular agents is shaped by rising TB cases, drug resistance trends, and evolving patent strategies. Here’s a detailed analysis:


Market Dynamics

The global tuberculosis drugs market was valued at $1.76 billion in 2021 and is projected to reach $2.41 billion by 2029, growing at a 9.68% CAGR [2][8]. Key drivers include:

  • MDR-TB and XDR-TB strains, responsible for ~500,000 annual cases [4][6].
  • TB-HIV co-infections, exacerbating mortality risks [2][10].
  • R&D investments in novel therapies, such as Telacebec (Qurient Co.) and PAN-TB collaboration evaluating five investigational regimens [2][19].

The active TB segment dominates due to its direct treatment demands, driven by 1.3 million TB-related deaths in 2020 [2]. Fixed-dose combinations (FDCs) like rifampicin + isoniazid + pyrazinamide sustain a 305 million annual tablet demand, with generics serving ~65% of the private sector [16].


Patent Landscape

Key Barriers and Strategies

  1. Bedaquiline:

    • India’s 2023 rejection of a secondary patent extension enabled generic production, reducing costs by ~55% [4][18]. Janssen’s licensing agreement with the Global Drug Facility (GDF) expanded access to 44 countries, though secondary patents remain in 30+ nations [18].
    • Over 50% of high-burden MDR-TB countries face potential patent barriers for bedaquiline formulations [13].
  2. Delamanid (Otsuka):

    • Granted patents in China, India, and Russia for formulations and combinations [1]. Limited data on African coverage raises access concerns [1].
  3. Isoniazid/Rifapentine (3HP):

    • Sanofi’s patents on pediatric/adult FDCs could deter generic competition, despite isoniazid’s prior-art status [11].

Innovation Trends

  • Novel Compounds: Benzothiazinones (MIC ≤0.06 µM) and Q203 analogs (Mycobacterium tuberculosis inhibitors) show promise against resistant strains [6][15].
  • Drug Delivery: Patents for drug-eluting meshes using rifampin highlight innovations in sustained-release technologies [9].

Challenges

  • Patent Proliferation: Over 12,283 TB-related patent families (2001–2021) exist globally, but ~50% are inactive, with 70% focused on treatment [12].
  • Market Monopolies: High-income countries hold 80% of patents, limiting access in LMICs [12].

Future Outlook

  • Collaborative Models: Initiatives like the PAN-TB collaboration and Medicines Patent Pool aim to accelerate regimen development and expand licensing [14][19].
  • Balancing Innovation/Access: India’s bedaquiline decision underscores prioritizing public health, potentially inspiring similar policies for delamanid and pretomanid [4][12].

“Patents can bar competitors, but access programs and generics are vital for equitable treatment.” [1][18]


Key Takeaways:

  • Market growth is driven by resistance crises and R&D breakthroughs.
  • Patent strategies increasingly balance monopolies with voluntary licensing.
  • LMICs face access hurdles despite generic advancements.

FAQs:

  1. What defines MDR-TB? Resistance to ≥2 first-line drugs (isoniazid + rifampicin) [3].
  2. How does India’s bedaquiline decision impact pricing? Generic costs dropped to ~$48/month [18].
  3. Which novel drugs target XDR-TB? Benzothiazinones and LysRS inhibitors [15].
  4. What role do FDCs play? Simplify regimens; rifampicin-based FDCs dominate [16].
  5. How do patents affect LMICs? 40% of high-burden countries face bedaquiline patent barriers [13].

References

  1. https://unitaid.org/uploads/OPC-67683_Patent_Landscape.pdf
  2. https://www.marketresearch.com/DataM-Intelligence-4Market-Research-LLP-v4207/Global-Tuberculosis-Drugs-32702200/
  3. https://meshb.nlm.nih.gov/record/ui?ui=D018088
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC10753402/
  5. https://www.tbvi.eu/projects/tbvac-horizon/tbvac-horizon-project-overview/
  6. https://pubmed.ncbi.nlm.nih.gov/34846976/
  7. https://www.treatmentactiongroup.org/wp-content/uploads/2021/11/hcv_tb_longacting_patent_trends.pdf
  8. https://straitsresearch.com/report/global-tuberculosis-drugs-market
  9. https://patents.google.com/patent/EP2734248B1/en
  10. https://pmc.ncbi.nlm.nih.gov/articles/PMC10348322/
  11. https://www.treatmentactiongroup.org/wp-content/uploads/2020/03/3hp_access_roadmap_and_patent_landscape.pdf
  12. https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/66618
  13. https://unitaid.org/uploads/TMC_207_Patent_Landscape.pdf
  14. https://www.ifpma.org/wp-content/uploads/2023/01/i2023_The-Globalisation-of-the-Pharmaceutical-Industry-Monograph.pdf
  15. https://pubmed.ncbi.nlm.nih.gov/39431728/
  16. https://pubmed.ncbi.nlm.nih.gov/10593708/
  17. https://pubmed.ncbi.nlm.nih.gov/33405882/
  18. https://time.com/6295511/how-an-innovative-deal-will-give-millions-access-to-cheaper-tuberculosis-drugs/
  19. https://www.jnj.com/media-center/press-releases/pan-tb-collaboration-to-advance-investigational-tuberculosis-drug-regimens-to-phase-2-clinical-trials

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