Drugs in ATC Class L02BX

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Drugs in ATC Class: L02BX - Other hormone antagonists and related agents

Tradename	Generic Name
PLENAXIS	abarelix
FIRMAGON	degarelix acetate
ABIRATERONE ACETATE	abiraterone acetate
YONSA	abiraterone acetate
ZYTIGA	abiraterone acetate
AKEEGA	abiraterone acetate; niraparib tosylate

L02BX Market Analysis and Financial Projection

The ATC class L02BX - Other hormone antagonists and related agents includes drugs targeting hormone-responsive conditions like advanced prostate cancer, endometriosis, and uterine fibroids. Key agents in this class are abarelix, degarelix, abiraterone, and relugolix, which modulate hormonal pathways to inhibit cancer growth or manage reproductive health disorders. Below is an analysis of their market dynamics and patent landscape:

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Market Dynamics

Key Drivers

1. Rising Cancer Prevalence:

   • Prostate cancer affects ~1.2 million men globally annually[12], driving demand for androgen deprivation therapies like degarelix and relugolix[2][10].
   • GnRH antagonists are also used in ovarian cancer and endometriosis, affecting ~10% of women of reproductive age[12].

2. Shift to Oral Therapies:

   • Oral agents like relugolix (approved in 2020) improve patient compliance vs. injectables[18]. Its adoption grew after NICE recommended it as the first oral androgen deprivation therapy in 2024[18].

3. Technological Advancements:

   • Long-acting formulations (e.g., degarelix implants) and combination therapies (e.g., abiraterone + corticosteroids) enhance efficacy[7][12].

4. Expanding Applications:

   • Relugolix is now used for uterine fibroids and endometriosis, broadening its market scope[10][18].

Market Segmentation

• By Drug Type:

  • GnRH Antagonists: Dominated by degarelix and relugolix, growing at 6.1% CAGR due to rapid onset and reduced side effects[3][12].
  • Hormone Synthesis Inhibitors: Abiraterone remains pivotal in metastatic prostate cancer despite generic competition[13][17].

• By Region:

  • North America: Holds ~49% market share (2023), driven by high prostate cancer incidence and healthcare spending[12].
  • Asia-Pacific: Fastest-growing region due to improving access to advanced therapies[12].

Competitive Landscape

• Major players include Ferring (degarelix), Janssen (abiraterone), and Takeda (relugolix).
• Strategic focus on combination therapies (e.g., abiraterone + prednisone[11]) and patent lifecycle management[16][17].

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Patent Landscape

Drug	Key Patents	Expiration	Status
Degarelix	US 9,415,085 (method of use)	2032[14][17]	Protected in US/EU; generics expected post-2032.
Abiraterone	US 8,822,438 (method of use)	2027[13][16]	Generic entry delayed until 2027 in key markets.
Relugolix	WO 2020/230094 (crystalline forms)	2039[15]	Formulation patents extend exclusivity.

Patent Challenges and Litigation

• Abiraterone: A 2018 U.S. ruling allowed generics but was reversed on appeal, delaying competition until 2027[16].
• Degarelix: Four ongoing litigations; earliest generic entry projected for 2029[17].

Future Outlook

• Generics Impact: Abiraterone generics entered India and South Africa post-2022, reducing costs[13].
• Pipeline Agents: Next-gen oral GnRH antagonists (e.g., TAK-385) aim to improve dosing intervals[18].

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Strategic Opportunities

1. Emerging Markets: Regulatory approvals in Asia and Africa for cost-effective generics[13].
2. Personalized Medicine: Biomarker-driven use of relugolix in prostate cancer subsets[18].
3. Digital Health Integration: Apps for monitoring hormonal therapy adherence[3].

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Highlight: "The rise of oral GnRH antagonists like relugolix reshapes treatment paradigms, balancing efficacy with patient-centric care." [10][18]

The L02BX market is poised for growth amid rising cancer burden and innovation, while patent expiries post-2030 will intensify competition from biosimilars and generics.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=L02BX&showdescription=yes
2. https://go.drugbank.com/drugs/DB06699
3. https://markwideresearch.com/gnrh-agonists-and-antagonists-market/
4. https://patents.google.com/patent/US9309245B2/en
5. https://www.businesswire.com/news/home/20200602005605/en/Global-Air-Traffic-Control-Market-Forecast-to-2025---Rapid-Advances-in-Technologies-Used-in-ATC-Systems---ResearchAndMarkets.com
6. https://pharmacy.moh.gov.my/sites/default/files/document-upload/msom-2018-2022-15102024_0.pdf
7. https://atcddd.fhi.no/filearchive/publications/1_2013guidelines.pdf
8. https://go.drugbank.com/drugs/DB00106
9. https://www.transparencymarketresearch.com/aldosterone-receptor-antagonists-market.html
10. https://pubchem.ncbi.nlm.nih.gov/compound/Relugolix
11. https://www.nice.org.uk/guidance/ta265/documents/prostate-cancer-draft-guideline-consultation-comments2
12. https://www.datamintelligence.com/research-report/gnrh-agonists-and-antagonists-drugs-market
13. https://medicinespatentpool.org/uploads/2020/04/Chapter-6-Patented-medicines-for-which-the-WHO-Expert-Committee-recommended-a-therapeutic-area-review-by-a-separate-working-group-Case-studies-on-lung-cancer-prostate-cancer-multiple-myeloma-and-breast-cancer.pdf
14. https://www.pharmacompass.com/patent-expiry-expiration/degarelix-acetate
15. https://pubchem.ncbi.nlm.nih.gov/patent/WO-2020230094-A1
16. https://www.jnj.com/media-center/press-releases/court-issues-ruling-in-zytiga-patent-infringement-litigation
17. https://www.drugpatentwatch.com/p/tradename/FIRMAGON
18. https://adisinsight.springer.com/drugs/800028257

Last updated: 2025-03-23