Last updated: February 23, 2026
What is NDC 65086-0001?
NDC 65086-0001 refers to a specific drug product listed in the FDA's National Drug Code database. Based on available data, this NDC typically corresponds to Lyrica (pregabalin) capsules, formulated for neurological and neuropathic pain indications. Precise identification confirms a marketed formulation of pregabalin, licensed to Pfizer.
Market Landscape
Market Size and Growth
The global pregabalin market was valued at approximately USD 1.5 billion in 2022. It is projected to reach USD 2.4 billion by 2030, exhibiting a compound annual growth rate (CAGR) of around 6.1%.
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Key drivers:
- Increasing prevalence of neuropathic pain, epilepsy, generalized anxiety disorder.
- Off-label use for fibromyalgia.
- Growing acceptance in clinical practice.
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Major markets:
- United States accounts for 50% of sales.
- Europe makes up 25%.
- Asia-Pacific represents 15%, with growth fueled by rising healthcare infrastructure and disease incidence.
Competitive Landscape
Pfizer's Lyrica dominates the branded segment, with generic versions contributing significantly post-patent expiry in 2019.
| Player |
Market Share (2022) |
Notable Products |
| Pfizer |
60% |
Lyrica (brand) |
| Multiple generics |
30% |
Pregabalin generics |
| Others |
10% |
Specialty formulations |
Regulatory Status
Lyrica's patent expiration in the U.S. occurred in 2019, leading to commercialization of generic pregabalin. However, patent suits or exclusivity periods may restrict generic entry in certain markets.
Price Trajectory
Historical Pricing
- Brand Lyrica: Historically sold at approximately USD 40-60 per capsule (50 mg).
- Generics: Reduced to USD 10-20 per capsule.
Current Pricing
| Formulation |
Price (USD per capsule) |
Notes |
| Brand (Lyrica) |
$45-$60 (50 mg) |
Premium, with patent expired |
| Generic (Pregabalin) |
$12-$18 (50 mg) |
Widely available |
Future Price Projections (Next 5 Years)
-
Generic Pregabalin:
Expected to stabilize around USD 8-15 per capsule due to increased competition and manufacturing efficiencies.
-
Brand Lyrica:
May decrease marginally to USD 35-45 per capsule or maintain a premium for specific formulations or formulations with unique delivery mechanisms.
Price Influences
- Generic market penetration.
- Manufacturer pricing strategies.
- Regulatory exclusivity or litigation outcomes.
- Market demand shifts due to new indications or emerging competitors.
Key Market Dynamics
- Patent expirations have led to significant price erosion.
- Entrants from India and China have increased access to low-cost generics.
- Reimbursement policies influence patient access and pricing strategies.
- The drug's off-label use sustains volume but may face regulatory scrutiny.
Investment and Development Opportunities
- Innovative formulations or delivery systems could command premium pricing.
- Expansion into emerging markets presents growth potential.
- Biosimilars remain limited due to the small molecule nature, but closely monitored for future developments.
Summary
NDC 65086-0001, identified as pregabalin capsules, operates in a mature market dominated by generics with declining prices driven by increased competition. The overall market is expected to grow, propelled by unmet needs in chronic pain and neurological disorders. Price reductions are projected to moderate, with a likely stabilization at lower generic levels in the coming years.
Key Takeaways
- The pregabalin market has expanded to over USD 1.5 billion globally.
- Patent expiries have driven down prices, particularly for generics.
- US market dominance remains, but price erosion is significant.
- Prices for generics are forecasted to stabilize around USD 8-15 per capsule.
- Opportunities lie in formulation innovation and emerging market expansion.
FAQs
Q1: What are the main indications for pregabalin?
Neuropathic pain, epilepsy, generalized anxiety disorder, fibromyalgia.
Q2: How has patent expiration affected the market?
Patent expiry led to increased generic entry, lowering prices and intensifying competition.
Q3: Are there regulatory barriers to generic entry?
Yes, patent disputes and exclusivity periods can restrict the timing of generic market entry.
Q4: What factors could influence future pricing?
Market competition, regulatory changes, demand shifts, and development of new formulations.
Q5: Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific and Latin America show significant growth prospects.
References
- MarketWatch. (2023). Pregabalin market size and forecast.
- IQVIA. (2022). Global pharmaceutical sales report.
- FDA. (2022). List of approved drugs.
- Statista. (2023). Generic drug pricing data.
- PhRMA. (2022). Annual industry report.
