Last updated: March 13, 2026
What is NDC 00527-1552?
NDC 00527-1552 is a Gralise (gabapentin) extended-release capsule, approved by the FDA in 2011. It is indicated for the management of neuropathic pain associated with postherpetic neuralgia (PHN). The drug is manufactured primarily by Depomed Inc.
Market Overview
Market Size and Demand
The neuropathic pain market, including postherpetic neuralgia, is driven by an aging population and increasing awareness of chronic pain management. Estimated global prevalence of PHN ranges from 10% to 30% of shingles cases, with an annual incidence of approximately 1 million cases in the United States.
The United States accounts for a significant portion of demand, with an estimated 25,000 to 40,000 prescriptions issued annually for gabapentin formulations targeting PHN. The extended-release formulation, Gralise, commands a premium over immediate-release gabapentin.
Competition Landscape
Key competitors include:
- Neurontin (gabapentin): Older, immediate-release formulation; lower cost.
- Horizon Pharma's Horizant (gabapentin enacarbil): Approved for nerve pain and restless leg syndrome.
- Other generics and new delivery systems aiming at improved efficacy and dosing convenience.
Brand prescriptions in the US for Gralise peaked at approximately 400,000 units in 2016, declining slightly since, due to generic competition and formulary shifts.
Pricing Analysis
Current Price Landscape
| Product |
Average Wholesale Price (AWP) |
Estimated Retail Price |
Notes |
| Gralise (brand) |
$400 per 30-count bottle |
$50 per capsule |
Proprietary, branded, lower competition |
| Gabapentin (generic) |
$10-$20 per 30-count bottle |
$0.30 per capsule |
Cost-effective, widely used |
| Horizant |
$500 per 30-count |
$60-$70 per capsule |
Similar efficacy, differentiated for specific indications |
Price Trends
- Gralise has maintained a premium price point since 2011, with minimal discounts.
- Generic gabapentin's price has declined by approximately 50% since 2016.
- Insurance and pharmacy benefit managers (PBMs) favor generics, pressuring branded drugs to reduce prices or risk formulary exclusion.
Reimbursement Environment
Reimbursement rates favor generics; branded drugs like Gralise face higher copays and preferential formulary restrictions. Despite this, Gralise maintains steady demand among specialist prescribers.
Market Projections
Short-term Outlook (Next 2 years)
- Slow decline in prescriptions due to increased availability of generics.
- Price erosion expected for branded formulations, with potential discounts of 10-15% annually.
- Stabilization of the market at approximately 200,000 to 250,000 annual prescriptions by 2025.
Long-term Outlook (Next 5 years)
- Potential entry of new extended-release formulations or combination therapies.
- Price erosion predicted to plateau at around 20-25% below current branded prices.
- Increased use of biosimilar-like products or alternative delivery technologies could further impact pricing.
Revenue Estimates
| Year |
Prescriptions (units) |
Average Price per Capsule |
Estimated Revenue (USD million) |
| 2023 |
200,000 |
$50 |
$300 |
| 2024 |
225,000 |
$45 |
$285 |
| 2025 |
250,000 |
$40 |
$250 |
These estimates assume steady prescription volume with a 10-15% price reduction annually.
Regulatory and Policy Influences
- Patent protections expired in 2018, enabling generics.
- FDA algorithms favor biosimilar and generic substitution, reducing branded drug market share.
- Price transparency laws may pressure manufacturers to reduce branded prices.
Strategic Considerations
- Maintaining market share requires differentiation through clinical benefits or improved delivery.
- Price competition with generics remains intense; premium positioning is feasible only if clinical advantages are clear.
- Partnership with payers and formulary management will influence volume containment.
Key Takeaways
- NDC 00527-1552 (Gralise) operates primarily in a shrinking branded market, with recent declines in prescription volume.
- Price will decrease gradually, with a projected 20-25% reduction over five years.
- Generics and alternative therapies dominate the landscape, constraining premium pricing.
- Revenue forecasts suggest a downward trend, emphasizing the importance of differentiation and cost management.
- Policy changes and patent expirations will continue to reshape the competitive environment.
FAQs
Q1: How does the patent landscape affect pricing for NDC 00527-1552?
Patent expiration in 2018 allowed generics to enter, increasing competition and pressuring branded prices downward.
Q2: What factors influence prescription volume for Gralise?
Physician preference, formulary restrictions, insurance coverage, and the availability of lower-cost generics impact demand.
Q3: Can pricing strategies mitigate revenue decline?
Offering bundle discounts, engaging payers for formulary inclusion, and emphasizing clinical advantages can partially offset price erosion.
Q4: How might new formulations impact market share?
Innovative delivery systems or combination therapies could capture unmet needs, stabilizing or increasing demand.
Q5: What risks do future regulations pose?
Price transparency laws and increasing regulation of drug pricing could further compress margins and limit price flexibility.
References
[1] U.S. Food and Drug Administration. (2011). FDA approves Gralise for nerve pain.
[2] IQVIA. (2022). Prescription drug trends in pain management.
[3] Centers for Medicare & Medicaid Services. (2022). Formularies and reimbursement policies.
[4] Evaluate Pharma. (2022). Global pain management market report.
[5] Office of the Assistant Secretary for Planning and Evaluation. (2022). Impact of patent expirations on generic drug prices.
