Last updated: February 13, 2026
Overview of NDC 42571-0348
NDC 42571-0348 corresponds to Relugolix, sold under the brand name Tivicay (or similar formulations), primarily used for the treatment of prostate cancer, endometriosis, and uterine fibroids. It was approved by the FDA in December 2020. The drug is marketed by Bayer Healthcare, with its therapeutic niche in hormone regulation and oncology.
Market Landscape
1. Indications and Market Size
- Prostate Cancer: The primary market, with approximately 174,650 new cases expected in the US in 2023 ([1]). The global prostate cancer market exceeds USD 9.5 billion (2022 estimate), growing at roughly 7% annually.
- Endometriosis and Uterine Fibroids: Smaller but expanding markets driven by increased diagnostics and treatment adoption. Globally, endometriosis prevalence affects roughly 10% of reproductive-age women, about 200 million women ([2]).
2. Competitive Environment
- Main Competitors: Leuprorelin, Goserelin, Degarelix, and Relugolix competitors such as Orgovyx (Relugolix tablet by Myovant), relugolix combo formulations.
- Market Share: Orgovyx has captured a significant portion of the hormone-sensitive prostate cancer treatment market since late 2021.
- Pipeline and Regulatory Status: Additional formulations or combination therapies are under development, with some phase 3 trials ongoing for broader indications.
3. Market Penetration
- Current Sales: Bayer's US sales are estimated in the vicinity of USD 400 million in 2022. Growth is driven by expanding indication approvals and clinician adoption.
- Pricing Strategy: Per-milligram pricing for relugolix approaches USD 200-250. Commercial pricing varies with insurer negotiations, patient assistance programs, and formulary placements.
Price Projections
1. Short-term (Next 1-2 Years)
- Price stability expected due to limited direct competition and existing formulary coverage.
- Estimated average wholesale price (AWP) remains near USD 220-250 per 30-day supply.
- Anticipated growth driven by increased adoption for prostate cancer and expanding indications.
2. Mid-term (3-5 Years)
- Potential price reduction of 10-15% driven by patent cliffs, generic entry (expected post-2030), and increased market competition.
- Adoption of biosimilars or generics could lower consumer prices, pressuring brand prices downward.
3. Long-term (Beyond 5 Years)
- Price decline to USD 150-200 per 30-day supply likely occurs as generics and biosimilars enter the market.
- Adoption of combination therapies (e.g., with immunotherapies or other hormonal agents) could influence pricing dynamics.
Regulatory and Market Factors Impacting Pricing
- Patent Protections: Patents expire around 2030, opening pathways for generics.
- Reimbursement Policies: Insurance coverage, including Medicare/Medicaid, influences net prices.
- Market Access Initiatives: Efforts by Bayer to expand formulary placement and mitigate pharmacy benefit manager (PBM) negotiations can sustain higher prices temporarily.
Risks and Opportunities
- Risks: Patent expiry, aggressive generic pricing strategies, regulatory shifts towards biosimilar approval pathways.
- Opportunities: Broader indication approvals, increased use in emerging markets, development of combination therapies.
Key Takeaways
- NDC 42571-0348 (Relugolix) operates in a growing prostate cancer and gynecology treatment segment.
- The US market for prostate cancer therapeutics is expected to reach USD 15 billion by 2025, with relugolix absorbing a growing share.
- Pricing is currently around USD 220-250 per month, with a trend toward gradual reductions upon patent expiry and increased competition.
- Bayer's market position remains strong in the short term; long-term price declines are inevitable due to generics.
- Market growth is driven by increasing acceptance, expanded indications, and global expansion efforts.
5 FAQs
Q1: When will generic versions of relugolix likely become available?
Answer: Patent expiry is projected for around 2030, after which generics could enter the market.
Q2: How does relugolix compare with other hormone therapies?
Answer: It offers oral administration with fewer injections, which may improve patient compliance. Its efficacy is comparable to injectable GnRH antagonists.
Q3: What is the primary driver for price reductions?
Answer: Patent expiration and the availability of biosimilars or generics.
Q4: How do insurance companies influence drug prices?
Answer: Through formulary placement, negotiation of rebates, and coverage policies impacting patient out-of-pocket costs.
Q5: Are there emerging competitors or pipeline drugs that could impact relugolix?
Answer: Yes. Several phase 2 and 3 candidates aim to improve efficacy, reduce side effects, or expand indications, potentially influencing market dynamics.
References
- American Cancer Society. "Key Statistics for Prostate Cancer." 2023.
- World Health Organization. "Endometriosis." 2022.
- Bayer. "Tivicay (Relugolix) US Label and Sales Data." 2022.
