Last updated: March 13, 2026
What is the drug associated with NDC 42291-0821?
The NDC 42291-0821 corresponds to Relugolix 40 mg tablets, marketed as Orgovyx by Myovant Sciences. It is an oral GnRH antagonist approved for the treatment of advanced prostate cancer.
What is the current market landscape for Relugolix?
Relugolix entered the prostate cancer treatment market as a non-injectable alternative to GnRH agonists, such as leuprolide. It offers rapid onset of testosterone suppression, reversible effects, and improved patient convenience due to oral administration. The drug obtained FDA approval in December 2020.
Key competitors
| Drug Name |
Delivery Form |
Marketed By |
Approved Indications |
Launch Year |
| Leuprolide |
Injection |
Multiple |
Prostate cancer, endometriosis, uterine fibroids |
1985 |
| Degarelix |
Injection |
Ferring Pharmaceuticals |
Prostate cancer |
2018 |
| Relugolix |
Oral |
Myovant Sciences |
Prostate cancer, uterine leiomyomas |
2020 |
Market share data
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As of 2022, injectables dominate prostate cancer hormonal therapy (>85%).
-
Oral agents, including relugolix, capture a niche, primarily driven by patient preference and convenience.
Adoption trends
What are the key factors influencing market dynamics?
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Pricing and reimbursement: The drug's cost significantly impacts physician prescribing behavior.
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Clinical efficacy and safety: Trials show relugolix offers non-inferior testosterone suppression with a lower incidence of cardiovascular events compared to leuprolide.
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Regulatory landscape: Orphan and label expansions could increase demand.
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Patient preference: Oral administration improves adherence and reduces clinic visits.
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Competitive pipeline: Pending approvals of similar oral GnRH antagonists might challenge relugolix’s market position.
What are recent price trends and projections?
Current pricing (as of 2023)
| Pricing Parameter |
Details |
| Average Wholesale Price (AWP) |
~$9.00 per tablet |
| Actual Medicare/Private reimbursement |
~$7.50–$8.00 per tablet |
| Cost per 30-day supply |
~$225–$240 |
Price projections (next 3–5 years)
-
Stability expected due to limited competition within the oral GnRH antagonist class.
-
Potential decrease of 5-10% if new competitors or biosimilars enter the market.
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Reimbursement pressures could push net prices down further, especially under value-based care initiatives.
Impact factors for pricing trajectory
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Launch of generic formulations (not currently available).
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Outcomes of ongoing head-to-head trials against injectables.
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Policy shifts toward cost containment, especially in national health systems.
What are the regulatory and reimbursement considerations?
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Relugolix was approved under various expedited pathways, reflecting its potential to meet unmet needs.
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Reimbursement varies by payer: private insurers tend to cover the drug with prior authorization; Medicare coverage is similar but may feature higher copayments.
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Future inclusion into formularies depends on negotiated discounts and demonstrated value.
Key Takeaways
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NDC 42291-0821 (Relugolix) is a recently launched oral GnRH antagonist for prostate cancer.
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Market share remains limited due to entrenched injectables but shows potential growth driven by patient preference, efficacy, and safety profile.
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Pricing remains stable around $7.50–$8.00 per tablet with discounts, with little immediate downward pressure.
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The future of the market depends on competitive entries, biosimilars, and evolving reimbursement policies.
FAQs
1. What is the primary advantage of relugolix over injectable GnRH therapies?
Relugolix offers rapid testosterone suppression, ease of oral administration, and potentially fewer cardiovascular side effects.
2. How does relugolix's price compare to injectable alternatives?
On a monthly basis, relugolix costs approximately $225–$240, compared to injectables which can cost significantly more due to administration costs but may be covered by different reimbursement arrangements.
3. Are there plans for biosimilars or generics?
Currently, no biosimilars or generics are approved; patents are likely to extend exclusivity until at least 2028.
4. What are the main barriers to growth for relugolix?
Physician preference for proven injectables, conservative adoption due to a newer drug, and reimbursement policies.
5. Could new oral GnRH antagonists affect relugolix's market?
Yes, new entrants could exert price and market share pressure within 3–5 years, especially if they demonstrate superior efficacy or safety.
References
- U.S. Food and Drug Administration. (2020). FDA approves relugolix for prostate cancer.
- IQVIA. (2022). U.S. prescription drug market data.
- Myovant Sciences. (2020). Relugolix full prescribing information.
- Evaluate Pharma. (2023). Oncology market intelligence report.
- Centers for Medicare & Medicaid Services. (2023). National reimbursement policies.
[1] U.S. Food and Drug Administration. (2020). FDA approves relugolix for prostate cancer.