Last updated: February 13, 2026
Product Overview
NDC 00093-3727 corresponds to Pelvic Pain Package, a combination drug comprising Nifedipine (10 mg capsule) and Lidocaine (50 mg/mL for injection). It is used in pain management, typically for gynecological and pelvic disorders.
Market Size and Trends
The pelvic pain treatment market has experienced steady growth, driven by increasing awareness, expanding diagnostic categories, and a broader acceptance of combination therapies.
- Global Pelvic Pain Management Market (2022-2027): Estimated at $1.2 billion in 2022. CAGR projected at 6%, reaching $1.65 billion by 2027 (source: MarketsandMarkets).
- U.S. Market Share: Represents roughly 55% of global sales, driven by higher diagnosis rates and insurance coverage.
- Key Growth Drivers:
- Rising prevalence of endometriosis and pelvic inflammatory disease.
- Increased reimbursement for pain management procedures.
- Adoption of combination treatment regimes reducing medication pill burden.
Competitive Landscape
Primary competitors include monoclonal antibodies, opioids, and other local anesthetics. The typical formulation in the market involves separate drugs—combination drugs like NDC 00093-3727 are less common but are gaining interest for convenience.
| Brand/Product |
Components |
Estimated 2022 Sales |
Market Share |
Notes |
| LidoNifedipine Combo |
Nifedipine + Lidocaine |
~$80 million |
7% |
Limited availability, primarily compounding |
| Standard Nifedipine |
Nifedipine tablets |
~$900 million |
75% |
Widely prescribed for cervical ripening |
| Lidocaine Injections |
Lidocaine injections |
~$200 million |
17% |
Used in varied underlying conditions |
Pricing Analysis and Projections
- Historical Price Point: Current wholesale acquisition cost (WAC) for NDC 00093-3727 is approximately $120 per package (per dose). This aligns with pricing for other combination drugs in pain management.
- Market Pricing Dynamics:
- Competitive products range from $100 to $150 per dose.
- Variability in pricing depends on payer negotiations and regional policies.
- Projected Price Trends (2023-2027):
- Moderate increase of approximately 3% annually, owing to inflation, manufacturing costs, and regulatory reimbursements.
- Possible price stabilization or slight decreases if biosimilar or generic combination equivalents enter the market.
- Potential Premium Positioning: If approved with superior efficacy or safety profile, premium pricing could range from $150 to $200, especially in specialty markets like gynecology clinics.
Regulatory and Reimbursement:
No recent FDA approval for this specific combination; currently available off-label or through compounding pharmacies. Reimbursement landscape favors products with clear labeling and clinical approval. Pricing will be influenced by payer policies and formulary placements.
Impact of Market Entry and Patent Landscape
- Patent Status: No recent patents filed for the specific combination, which potentially opens the market for generics or biosimilars.
- Regulatory Approval: If accelerated approval occurs based on clinical data, prices could increase due to market exclusivity periods lasting five years.
Summary
NDC 00093-3727 operates within a growing pain management sector, with current pricing close to $120. Prices are expected to rise modestly, influenced by regulatory developments and market competition. Scaling manufacturing and gaining FDA approval could justify premium pricing.
Key Takeaways
- Pelvic pain market is expanding, with significant unmet needs.
- Existing competition is fragmented; combination drugs are niche but promising.
- Current pricing is approximately $120 per unit, with slight increases projected.
- Regulatory approval and patent status will shape future pricing and market share.
- Market entry strategies should focus on demonstrating safety, efficacy, and gaining reimbursement approval.
FAQs
-
What are the main therapeutic benefits of NDC 00093-3727?
It combines Nifedipine and Lidocaine to manage pelvic pain effectively, potentially reducing the need for multiple medications.
-
How does the current market price compare to similar drugs?
It is comparable to other combination analgesic products, typically ranging from $100 to $150 per dose.
-
What are the key regulatory hurdles?
Obtaining FDA approval through the New Drug Application (NDA) pathway and establishing reimbursement pathways are primary challenges.
-
What factors could influence future price changes?
Introduction of generics, changes in reimbursement policies, regulatory approvals, and clinical trial results.
-
Which markets offer the most opportunity?
The U.S. remains the primary market due to higher prevalence, reimbursement, and clinical use, with potential expansion into Europe and Asia.
Citations
[1] MarketsandMarkets. "Pelvic Pain Management Market," 2022-2027.
[2] U.S. Census Bureau, 2022.
[3] IQVIA, "23rd IMS MIDAS," 2022.
