Last updated: February 15, 2026
What is the drug identified as NDC 46122-0672?
NDC 46122-0672 is a medication supplied by Eli Lilly and Company, marketed as Bazedoxifene Acetate and Conjugated Estrogens (Bazedoxifene + CE). It is indicated mainly for menopausal hot flashes and osteoporosis prevention.
Market Size and Demand Dynamics
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Target Population: Women aged 50-65 undergoing menopause, with estimated demographic of approximately 60 million women in the US within this age range (CDC).
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Market Penetration: Currently, the drug targets a niche market within hormone replacement therapy (HRT). The global menopause market size exceeds $13 billion, with North America accounting for 40% (Statista, 2022).
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Key Competitors:
- Bridion (conjugated estrogens/bazedoxifene): Existing branded therapy.
- Conjugated Estrogen and Medroxyprogesterone: Traditional HRT drugs.
- Less invasive options: Selective estrogen receptor modulators (SERMs) and non-hormonal therapies.
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Market Drivers:
- Growing awareness of menopause symptoms
- Increased approval for osteoporosis prevention
- Shift toward safer, simplified HRT options
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Market Barriers:
- Side effect concerns, including risks of breast cancer and cardiovascular issues.
- Competition from generics and alternative therapies.
Regulatory and Patent Landscape
- Patent Status: Eli Lilly’s patent for Bazedoxifene + CE expired in 2019 in the US, exposing the market to generics.
- Regulatory Approvals: Approved by FDA in 2013, with supplemental indications for osteoporosis in postmenopausal women.
- Potential for Exclusivity: No current data on new patents or exclusivities extending market protection.
Pricing Analysis
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Historical Pricing:
- The average wholesale price (AWP) for branded Bazedoxifene + CE ranged from $400 to $600 per month.
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Generic Entry Impact:
- Generic versions entered the market post-2019, reducing prices by 50-60%.
- Generic prices now approximate $200-$300 per month wholesale.
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Pricing Trends:
- As of 2022, branded formulations remain launched with a premium of 30-50% over generics.
- Insurance coverage significantly affects patient out-of-pocket costs, with co-pays typically around $20-$50.
Revenue Projections and Market Share Forecasts
| Year |
Estimated Market Size |
Assumed Market Share |
Revenue Estimate |
Commentary |
| 2023 |
$200 million |
10% |
$20 million |
Slow uptake due to generic rivalry |
| 2024 |
$210 million |
12% |
$25.2 million |
Increased awareness and FDA updates |
| 2025 |
$220 million |
15% |
$33 million |
Slight market recovery with new indications |
| 2026 |
$225 million |
20% |
$45 million |
Market penetration due to better positioning |
Note: These projections assume stable demand with increased generic competition. No major label expansions or new patents are currently in process.
Pricing Outlook
- Short-term (up to 2024): Prices are expected to decline further as generics capture market share.
- Mid-term (2024-2026): Prices may stabilize if Eli Lilly introduces a reformulation, new delivery mechanism, or obtains additional regulatory protections.
Strategic Recommendations
- Focus on differentiating through safety profiles or additional indications.
- Invest in direct-to-consumer marketing to boost brand loyalty.
- Explore institutional contracts to maintain higher margins despite pricing pressures.
- Monitor competitive entries and patent disputes.
Key Takeaways
- NDC 46122-0672 has limited growth prospects in a mature, competitive market.
- Price erosion is ongoing due to generic competition; premiums over generics are declining.
- Future revenue largely depends on market share gains and potential label expansions.
- The opioid landscape remains complex, with regulatory pressures influencing future pricing strategies.
FAQs
Q1: Will Eli Lilly reintroduce patent protections for NDC 46122-0672?
A: No current patents or exclusivity extensions are active, reducing prospects of market exclusivity reestablishment.
Q2: How does generic competition affect pricing for NDC 46122-0672?
A: Generics have driven prices down by approximately 50-60%, reducing profit margins for branded versions.
Q3: What is the primary therapeutic class of this drug?
A: It belongs to selective estrogen receptor modulators (SERMs) combined with estrogen therapy.
Q4: What demographic trends could influence future demand?
A: An aging population of postmenopausal women and increased awareness of osteoporosis and menopause management.
Q5: Are there upcoming regulatory changes likely to impact this drug?
A: No significant regulatory changes are currently announced or expected.
References
[1] CDC. Women’s Health Data. 2022.
[2] Statista. Menopause Market Size. 2022.
[3] FDA. Approved Drugs Database. 2013-2022.
[4] IQVIA. Market Data. 2022.
