Last updated: February 27, 2026
What is NDC 00904-0788?
NDC 00904-0788 identifies a branded or generic drug in the U.S. healthcare system. Based on the National Drug Code (NDC), this specific code corresponds to Pregabalin capsules, 75 mg. Pregabalin is primarily used to treat neuropathic pain, fibromyalgia, epilepsy, and generalized anxiety disorder.
Market Overview
Market Segments
- Neuropathic Pain: Accounts for the largest share, reflecting chronic pain management needs.
- Epilepsy: Represents a smaller portion, driven by epilepsy patients.
- Fibromyalgia and GAD: Growing indications, especially in mental health.
Key Market Players
| Company |
Market Share |
Product Name |
Pricing Strategy |
| Pfizer |
45% |
Lyrica |
Premium pricing, brand dominance |
| Mylan |
30% |
Pregabalin (generic) |
Competitive pricing, 1st generation generic |
| Teva |
15% |
Pregabalin |
Cost-effective generic options |
| Others |
10% |
Various generics |
Low-cost, regional options |
Market Size & Trends
- Global pregabalin market was valued at approximately $5 billion in 2022.
- Compound Annual Growth Rate (CAGR) forecast: 4% (2023–2028).
- U.S. prescription volume of pregabalin: ~25 million prescriptions annually [1].
Regulatory & Patent Landscape
- Original patent for Lyrica expired in 2018 in the U.S.
- Multiple generics entered post-patent expiry, increasing competition.
- Patent filings for formulation and delivery methods persist in other jurisdictions, potentially delaying generics abroad.
Price Dynamics
Historical Pricing
| Year |
Average Wholesale Price (AWP) per 75 mg capsule |
Notes |
| 2018 |
$1.00 |
Post-patent expiry, initial drop in branded price |
| 2020 |
$0.80 |
Increased generic competition |
| 2022 |
$0.50 |
Market saturation with generics |
Current Pricing Estimates (2023)
| Source |
Estimated AWP per capsule |
Remarks |
| First Databank |
$0.45 |
Generic capsule, 75 mg |
| IQVIA |
$0.40–$0.50 |
Median wholesale market rate |
Price Projections (Next 3–5 Years)
- Scenario 1: Continued Generic Competition
Average price persists near $0.40–$0.50 due to stable competition, with minor fluctuations influenced by supply chain costs.
- Scenario 2: Introduction of Biosimilars or Specialty Formulations
Potential price increases if new formulations address unmet needs, such as extended-release versions or combination drugs, could push prices upward by an estimated 10–15%.
- Scenario 3: Market Contraction or Regulatory Changes
Introduction of stricter prescribing guidelines or formulary shifts favoring alternative drugs (e.g., gabapentin) may reduce demand, pressuring current prices downward.
Market Risks and Opportunities
- Risks: Price erosion from increased generics, patent litigation delays, and regulatory restrictions.
- Opportunities: Expanding indications, especially in mental health, and formulation innovations that command higher pricing.
Key Market Drivers
- Incremental genericization: Accelerates price erosion but expands overall market volume.
- New clinical evidence: Supports broader off-label use, boosting prescription volume.
- Insurance coverage: Trends toward formularies favoring generics reduce out-of-pocket costs, increasing utilization.
Final Assessment
The drug identified by NDC 00904-0788, pregabalin 75 mg capsules, is experiencing price stabilization around $0.40–$0.50 per capsule. Market saturation with generics limits upward pricing potential, though volume growth offsets revenue declines. The competitive landscape is stable, with major players maintaining significant market shares.
Key Takeaways
- The pregabalin market has shifted from high-margin branded sales to high-volume generic sales since patent expiry in 2018.
- Prices for 75 mg capsules are expected to remain within the $0.40–$0.50 range over the next five years.
- Demand is driven by multiple indications, especially neuropathic pain and epilepsy, with some expansion into mental health.
- Competitive pressures limit price hikes but sustain growth through increased prescription volumes.
- Regulatory and formulation innovations could influence future pricing and market structure.
FAQs
1. Will the price of pregabalin 75 mg increase or decrease?
Prices are likely to stabilize or decrease slightly due to generic competition. Significant hikes are unlikely unless new formulations or indications emerge.
2. How does patent expiration affect the market?
Patent expiration allows generic companies to enter, increasing supply, reducing prices, and expanding market volume.
3. What are alternative drugs that could impact pregabalin sales?
Gabapentin, duloxetine, and newer anticonvulsants or neuropathic pain medications may replace pregabalin in some indications, affecting demand and pricing.
4. How does insurance coverage influence market dynamics?
Favoring generics on formularies increases prescribing volume, mitigates price erosion, and lifts overall revenues despite lower unit prices.
5. Are there regulatory risks impacting pregabalin pricing?
Yes. Regulatory restrictions or off-label use limitations can influence prescription volume and pricing strategies across different markets.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
