Drugs in ATC Class L01BA

Up to Top Level ATC Classes

Up to L - Antineoplastic and immunomodulating agents

Up to L01 - ANTINEOPLASTIC AGENTS

Up to L01B - ANTIMETABOLITES

Drugs in ATC Class: L01BA - Folic acid analogues

Tradename	Generic Name
METHOTREXATE	methotrexate
JYLAMVO	methotrexate
OTREXUP	methotrexate
OTREXUP PFS	methotrexate
RASUVO	methotrexate
REDITREX	methotrexate
ABITREXATE	methotrexate sodium

L01BA Market Analysis and Financial Projection

The ATC Class L01BA (Folic Acid Analogues) encompasses critical antineoplastic agents, primarily methotrexate, leucovorin, pralatrexate, and pemetrexed, which are integral to treating cancers and managing chemotherapy toxicity. Below is an analysis of their market dynamics and patent landscape.

---

Market Dynamics

Growth Drivers

1. Rising Cancer Burden: Increasing colorectal cancer cases (projected to drive the leucovorin calcium market to grow at a CAGR of ~7.3% through 2033)[1] and osteosarcoma therapies (where methotrexate is pivotal)[6].
2. Demand for Rescue Therapies: Leucovorin mitigates methotrexate toxicity, a necessity in high-dose chemotherapy regimens for blood disorders and osteosarcoma[1][4].
3. Generic Expansion: Methotrexate dominates with 58 NDAs and 92 international patents expiring by 2025–2034, enabling price-competitive generic formulations[6][10]. The global methotrexate market is projected to reach $1.06 billion by 2034[10].

Segment Analysis

• Formulation Types:	Segment	Market Share	Key Features
  Injectables	Dominant (50–500 mg doses)	Preferred for bioavailability in acute settings[1]
  Tablets	Niche (5–25 mg doses)	Used for maintenance therapy[1]

• Therapeutic Applications:

  • Colorectal cancer (leucovorin + 5-fluorouracil)[1]
  • Megaloblastic anemia (leucovorin rescue)[1]
  • Rheumatoid arthritis and psoriasis (low-dose methotrexate)[13]

Challenges

• Toxicity risks (e.g., seizures in vulnerable populations)[1].
• Compatibility issues with capecitabine and cotrimoxazole[1].

Key Players

• Methotrexate: Mylan, Teva, Hikma, and Fresenius Kabi dominate generics with 20+ suppliers[6][10].
• Leucovorin: BluePoint Laboratories and RMPL Pharma lead injection production[1].

---

Patent Landscape

Core Innovations

1. Folate Receptor-Targeted Therapies:

   • Patent US9637547B2 covers monoclonal antibodies detecting folate receptor 1 (FRα), pivotal in ovarian and lung cancer diagnostics[2].
   • Emerging bispecific antibodies (e.g., targeting PD1/PDL1 and CD3) show accelerated patent filings since 2010, with 400+ families published in 2023[3].

2. Drug Delivery Systems:

   • CN107744593A introduces folate-targeted slow-release carriers for osteosarcoma, enhancing drug delivery while minimizing methotrexate side effects[11].
   • GB2531940A details stabilized methotrexate liquid formulations for oral use in autoimmune disorders[13].

Strategic IP Trends

• Biosimilar Competition: Methotrexate’s U.S. Patent No. 6,500,829 expired in 2022, opening pathways for generics like Actavis’ levoleucovorin[4].
• Bispecific Antibody Wars: Over 50% of patent families focus on tumor antigens (e.g., BCMA, PSMA) and immune checkpoints (PD1/PDL1). Key players include Amgen and Genentech[3].

Collaborations & Oppositions

• 52 newcomers in bispecific antibody patents, primarily U.S.- and Asia-based[3].
• EP oppositions reflect intense competition, with strategies to block rival portfolios[3].

---

Future Outlook

• Emerging Therapies: FRα-targeted antibody-drug conjugates (e.g., ImmunoGen’s mirvetuximab) are reshaping ovarian cancer treatment[5].
• Market Expansion: Folic acid analogues in fortified foods and prenatal supplements (CAGR 7.3% through 2033)[15].

The development of multifunctional folate formulations and biofortification technologies will drive next-generation innovations.
— Industry Analyst, Verified Market Research[1]

---

Key Takeaways

• Methotrexate and leucovorin remain pillars in oncology, with generics expanding access.
• FRα-targeted therapies and bispecific antibodies dominate IP innovation.
• Sustainability and bioengineering (e.g., slow-release carriers) are critical for reducing toxicity.

References

1. https://www.verifiedmarketresearch.com/product/leucovorin-calcium-market/
2. https://patents.google.com/patent/US9637547B2/en
3. https://www.businesswire.com/news/home/20250224366580/en/Bispecific-Antibody-and-Cancer-Patent-Landscape-Analysis-2025-with-IP-Profiles-of-Key-Players-Amgen-Genentech-Roche-GenMab-Janssen-Regeneron-and-Xencor---ResearchAndMarkets.com
4. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208723Orig1s000SumR.pdf
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC11901361/
6. https://www.drugpatentwatch.com/p/generic-api/methotrexate
7. https://www.drugpatentwatch.com/p/generic-api/METHOTREXATE+SODIUM
8. https://patents.google.com/patent/US6465013B1/en
9. http://medbox.iiab.me/kiwix/wikipedia_en_medicine_2019-12/A/ATC_code_L01
10. https://www.drugpatentwatch.com/p/generic/methotrexate
11. https://patents.google.com/patent/CN107744593A/en
12. https://list.essentialmeds.org/files/trs/KmctuAAMtPBorqeQRged3u44S6eeGKQPvOfhGr65.pdf
13. https://patents.google.com/patent/GB2531940A/en
14. https://www.efpia.eu/media/b1rcqvlt/annex-2-patient-impact-survey_human-health-associations.pdf
15. https://www.promarketreports.com/reports/folic-acid-market-21855
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC3156879/

Last updated: 2025-03-24