Last updated: March 13, 2026
What is NDC 76385-0107?
NDC 76385-0107 corresponds to Myovant Sciences' relugolix, which is marketed under the brand name Orgovyx. It is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved for the treatment of adult men with prostate cancer and for women with heavy menstrual bleeding associated with uterine fibroids.
Current Market Position
Relugolix entered the prostate cancer treatment landscape as an oral alternative to injectable GnRH therapies. Notable competitors include:
- Leuprolide (Lupron, Lupron Depot)
- Goserelin (Zoladex)
- Degarelix (Firmagon)
In the uterine fibroid segment, relugolix competes with:
- Leuprorelin
- Norethindrone acetate (for heavy menstrual bleeding)
The drug received FDA approval in December 2020, positioning it as a novel oral GnRH antagonist with potential advantages over injectable options.
Market Size Analysis
Prostate Cancer Segment
- Global prostate cancer therapeutics market was valued at approximately $8 billion in 2021.
- The GnRH antagonist segment accounted for about 20% of this market.
- The market is projected to grow at a compound annual growth rate (CAGR) of 8-10% from 2022 to 2030, driven by increased diagnosis rates and rising adoption of oral therapies.
Uterine Fibroids Segment
- The U.S. uterine fibroids market was valued at $1.4 billion in 2022.
- GnRH antagonists are gaining prevalence, especially with FDA approval of relugolix in this indication.
- The segment is projected to expand at a CAGR of 6-9% through 2030.
Price Position and Strategy
Current Pricing
- Relugolix (Orgovyx) has a wholesale acquisition cost (WAC) of approximately $12,900/month.
- This contrasts with injectable GnRH therapies, which range between $8,000 to $15,000 per course, depending on dosing and duration.
Competitive Pricing Dynamics
| Drug |
Formulation |
Approximate WAC per month |
Delivery Mode |
Market Position |
| Relugolix |
Oral |
$12,900 |
Oral |
First oral GnRH antagonist |
| Leuprolide |
Injection |
$8,000 - $12,000 |
Injectable |
Standard injectable therapy |
| Goserelin |
Injection |
$8,500 - $10,500 |
Injectable |
Similar to leuprolide |
| Degarelix |
Injection |
~$14,000 |
Injectable |
Recent injectable option |
Pricing Outlook and Projections
- Near-term (2023-2025): prices expected to remain stable, with reimbursement policies influencing net pricing.
- Mid-term (2026-2030): potential reductions driven by increased competition, biosimilar availability, and payer pressures.
- Long-term (post-2030): possible price adjustments as patent expiry approaches and generics or biosimilars enter the market.
Key Factors Affecting Future Prices
- The cost-effectiveness of oral over injectable therapies.
- Reimbursement policies favoring outpatient oral treatments.
- Patent exclusivity expiration, likely around 2030.
- Entry of biosimilars or generics if patents are challenged or expire.
Market Penetration and Revenue Projections
Annual Sales Estimates
| Year |
Estimated Global Sales |
Volume (Units) |
Average Price per Unit |
Market Share |
| 2023 |
$150 million |
11,600 |
$12,900/month * 12 = approx. $155,000/year |
~2-3% of GnRH market |
| 2025 |
$300 million |
23,200 |
Adjusted for discounts and competition |
Increased share |
| 2030 |
$700 million |
54,000 |
Lower prices, increased adoption |
Leading oral option in prostate cancer |
Geographic Variations
- The U.S. dominates sales due to regulatory approval, reimbursement infrastructure, and physician familiarity.
- European markets are open for further expansion, with pricing typically lower by 20-30% due to price regulation.
Risks & Opportunities
Risks
- Price erosion via biosmirals or generics.
- Reimbursement restrictions limiting uptake.
- Competition from new oral therapies or improved injectable formulations.
Opportunities
- Expansion into new indications such as endometriosis, if approved.
- Strategic partnerships for broader distribution.
- Market penetration in emerging countries with growing prostate and uterine fibroid burdens.
Summary
Relugolix (NDC 76385-0107) occupies a significant niche as the first oral GnRH antagonist approved for prostate cancer and uterine fibroids. Its current pricing is around $12,900/month, positioning it as a premium-priced option. Market growth hinges on increased awareness, reimbursement policies, and eventual patent expiration, which could lead to downward price adjustments. Expansion into additional indications and markets presents further upside potential.
Key Takeaways
- The global prostate cancer therapeutics market exceeds $8 billion; GnRH antagonists hold a growing fraction.
- The uterine fibroids market is $1.4 billion with strong crossover potential.
- Current pricing remains high; competitive pressures forecast slight reductions by 2030.
- Market penetration risks include biosimilar entry and reimbursement hurdles.
- Opportunities include expanding indications and geographic reach.
FAQs
1. Will the price of relugolix decrease after patent expiry?
Likely, as biosimilars or generics enter the market, prices may decline. The patent is expected to expire around 2030.
2. How does relugolix compare to injectable GnRH therapies in terms of cost and convenience?
Relugolix costs approximately $12,900 per month, comparable to injectables but offers the convenience of oral administration, potentially improving patient adherence.
3. What factors influence the future sales potential of relugolix?
Market expansion, reimbursement policies, competition, and pipeline approvals in new indications.
4. Are there regional differences in the pricing of relugolix?
Yes. The U.S. maintains the highest prices due to less regulation, while European markets typically price drugs lower.
5. What are the main competitive threats to relugolix?
Entry of biosimilars, new oral therapies with better efficacy or lower prices, and innovations in injectable formulations.
References
[1] IQVIA. (2022). The Global Use of Medicine in 2022.
[2] FDA. (2020). FDA approves relugolix for prostate cancer.
[3] Market Research Future. (2022). Global GnRH market analysis.
[4] Evaluate Pharma. (2022). Oncology market report.
[5] CMS. (2022). Medicare reimbursement policies for oncology drugs.
