Drugs in ATC Class M04AB

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Drugs in ATC Class: M04AB - Preparations increasing uric acid excretion

Tradename	Generic Name
COL-PROBENECID	colchicine; probenecid
COLBENEMID	colchicine; probenecid
POLYCILLIN-PRB	ampicillin/ampicillin trihydrate; probenecid
PRINCIPEN W/ PROBENECID	ampicillin/ampicillin trihydrate; probenecid
PROBAMPACIN	ampicillin/ampicillin trihydrate; probenecid
PROBEN-C	colchicine; probenecid

M04AB Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class M04AB (Preparations increasing uric acid excretion) reflect a mix of established therapies, emerging innovations, and evolving regulatory frameworks. This class includes uricosuric agents like probenecid, benzbromarone, and newer entrants such as dotinurad and lesinurad, which target uric acid transporters like URAT1 to enhance excretion.

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Market Dynamics

Growth Drivers

1. Rising Prevalence of Gout and Hyperuricemia:

   • Hyperuricemia affects ~20% of the global population, with gout incidence increasing due to aging demographics, obesity, and kidney dysfunction[3][8][15].
   • By 2030, the hyperuricemia drug market is projected to reach $9 billion, driven by uricosuric agents like probenecid[8][13].

2. Innovation in Drug Development:

   • Dotinurad, a selective URAT1 inhibitor approved in Japan (2020), demonstrates superior efficacy with Phase 3 trials showing 54.9% plasma urate reduction at 4 mg doses[1].
   • Novel dual-mechanism drugs like KUX-1151 (xanthine oxidase + URAT1 inhibitor) and recombinant uricase therapies (e.g., ALLN-346) are expanding treatment options[8][10].

3. Strategic Partnerships and Regional Expansion:

   • Collaborations like Kissei Pharmaceutical and Pfizer aim to commercialize next-gen therapies globally[8].
   • Dotinurad is under NDA review in China (2024), while Urica Therapeutics advances Phase 2 trials in the U.S.[1].

Challenges

• Side Effects: Older uricosurics like probenecid face limited use due to gastrointestinal issues and drug interactions[11][12].
• Competition from Alternatives: Xanthine oxidase inhibitors (e.g., allopurinol) dominate first-line treatment, though uricosurics are preferred for patients with kidney impairment[14][15].

Regional Trends

• Asia-Pacific: Leading growth due to high gout prevalence (1–2% of adults) and rapid approvals (e.g., Japan’s dotinurad)[1][15].
• North America: Probeneicd market exceeds $120 million (2023), driven by chronic gout management and combo therapies[13].

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Patent Landscape

Key Patents and Innovations

1. Probenecid:

   • Off-patent but retains relevance due to secondary uses (e.g., enhancing antibiotic bioavailability)[11][12].
   • New formulations aim to improve tolerability, with 3.5% CAGR projected through 2027[13].

2. Dotinurad:

   • Protected under patents (CAS 1285572-51-1) with exclusivity in Japan until ~2035[1].
   • Mechanism: High selectivity for URAT1 reduces off-target effects compared to older agents[1].

3. Novel Therapies:

   • ALLN-346: An oral engineered uricase (patented) reduced hyperuricemia by 44–69% in preclinical models[10].
   • KUX-1151: Dual-inhibitor therapy (URAT1 + xanthine oxidase) under development with global commercialization rights secured[8].

4. Diagnostic Patents:

   • Methods for uric acid detection (e.g., US4095948A) and IL-1β-driven pathology treatments (e.g., US8569017) highlight ancillary innovation[4][9].

Regulatory and Approval Pathways

• Decentralized Procedures (EU): Streamline approvals across member states, facilitating market entry for generics[2][7].
• Japan and China: Fast-tracked approvals for dotinurad reflect regulatory support for uricosurics in high-burden regions[1].

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Competitive Landscape

Drug	Status	Key Players	Differentiation
Probenecid	Generic	Teva, Ipca Laboratories	Low cost, adjunctive antibiotic use
Dotinurad	Approved (Japan, 2020)	Fuji Yakuhin	High selectivity, minimal drug interactions
Lesinurad	Approved (US, EU)	AstraZeneca	Combo therapy with xanthine oxidase inhibitors
ALLN-346	Preclinical/Phase 1	Allena Pharmaceuticals	Oral uricase for gut-specific urate degradation

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Future Outlook

• 2025–2030: The global uric acid inhibitor market will grow at 8.26% CAGR, driven by aging populations and renal disease prevalence[3][14].
• Patent Expiries: Probeneicd generics dominate, while novel URAT1 inhibitors and biologics (e.g., pegloticase) capture premium segments[17].
• Personalized Medicine: Biomarker-driven therapies (e.g., IL-1β inhibitors) and combo regimens will shape next-generation uricosurics[4][8].

“The integration of precision medicine and real-time analytics is reshaping uricosuric drug development, balancing efficacy with safety.” — 360iResearch[14]

References

1. https://synapse.patsnap.com/drug/38428d1fd28d4fe58c82cb579d3bcd42
2. https://www.zva.gov.lv/sites/default/files/2017-12/Baltic%20Statistics%20on%20Medicines%202013%20-%202015.pdf
3. https://www.imarcgroup.com/hyperuricemia-market
4. https://patents.justia.com/patents-by-us-classification/436/99
5. https://www.precedenceresearch.com/air-traffic-control-equipment-market
6. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/nvNsI8S7K9U.pdf
7. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/09vLW9zMlcw.pdf
8. https://www.maximizemarketresearch.com/market-report/hyperuricemia-drugs-market/234607/
9. https://patents.google.com/patent/US4095948A/en
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC7732547/
11. https://go.drugbank.com/drugs/DB01032
12. https://www.pharmacompass.com/chemistry-chemical-name/probenid
13. https://www.marketresearchforecast.com/reports/probenecid-365152
14. https://www.360iresearch.com/library/intelligence/uric-acid-production-inhibitors
15. https://www.omrglobal.com/industry-reports/antigout-drug-market
16. https://www.360iresearch.com/library/intelligence/probenecid-tablets
17. https://en.wikipedia.org/wiki/ATC_code_M04