Last updated: February 27, 2026
What is NDC 50991-0626?
NDC 50991-0626 is a drug identified by the National Drug Code (NDC). It corresponds to Pregabalin capsules (brand name: Lyrica), manufactured by Pfizer. Approved by the FDA for neuropathic pain, fibromyalgia, and as an adjunct therapy for certain seizures, it has an established market presence since its approval in 2004.
Market Size and Demand Drivers
Key Indications
- Neuropathic pain associated with diabetic peripheral neuropathy
- Fibromyalgia
- Postherpetic neuralgia
- Adjunct therapy for partial seizures
Market Dynamics
- Global Market Value (2022): Estimated at USD 5 billion [1]
- US Market Share: Approximate USD 2.5 billion, representing roughly 50% of global sales [2]
- Growth Rate: Compound annual growth rate (CAGR) expected at 4% from 2023 to 2028, driven by expanding indications and increased diagnosis rates [3]
- Patient Population: Approximately 8 million patients in the US alone are eligible for treatment, considering chronic neuropathic pain and fibromyalgia [4]
Competitive Landscape
- Major Competitors: Gabapentin (Neurontin), Pregabalin (Lyrica), Duloxetine (Cymbalta)
- Market Share (2022): Lyrica holds about 80% of pregabalin prescriptions in the US, remaining dominant due to brand loyalty and proven efficacy [5]
- Generic Entry: Since the patent expiry for Lyrica in 2018, multiple generics entered the market, significantly reducing prices [6]
- Emerging Approvals: Pharmaceutical companies are developing biosimilars and novel formulations, targeting improved bioavailability and reduced side effects [7]
Pricing Trends and Projections
Current Pricing
| Product Type |
Average Wholesale Price (AWP) per capsule |
Notes |
| Brand (Lyrica) |
USD 6.50 |
Brand price, still high despite patent expiry |
| Generic (Multiple producers) |
USD 1.00 - USD 2.50 |
Prices vary depending on manufacturer and quantity |
Price Trajectory (2023-2028)
- 2018: Patent expiration led to a 70% decline in branded Lyrica prices
- 2020: Stabilization around USD 2.00 per capsule for generics
- 2023: Slight upward trend anticipated due to new formulation trials and potential biosimilar entrants [8]
- 2024-2028: Projected gradual increase in average generic prices as supply chain stabilizes and demand expands, reaching USD 2.50 – USD 3.00 per capsule
Factors Influencing Price Projections
- Patent and Exclusivity Status: No recent patent filings; patent expiry in 2018 removes exclusivity
- Regulatory approvals: Potential approval of biosimilars or new formulations may impact pricing
- Manufacturing costs: Slight increases due to raw material costs and supply chain challenges
- Market demand: Rise in diagnosed cases and off-label uses can elevate demand, supporting higher prices
- Reimbursement policies: Insurance coverages and formulary preferences influence actual sale prices and patient costs
Regulatory and Policy Environment
- FDA: Continues to facilitate generic competition, with generic versions accounting for 90% of sales [9]
- Pricing regulations: US laws limit drug pricing transparency; Medicare and Medicaid negotiations can influence actual acquisition costs
- Biosimilar pathway: FDA’s ongoing approval of biosimilars may affect future price competition
Risks and Opportunities
Risks
- Entry of biosimilars or alternative therapies could reduce prices further
- Regulatory delays or safety concerns could slow market growth
- Supply chain disruptions may impact availability and pricing
Opportunities
- Development of formulations with improved delivery (e.g., extended-release)
- Expansion into new markets with unmet needs in neuropathic pain
- Enhanced insurance reimbursement strategies
Key Takeaways
- NDC 50991-0626 (Lyrica) remains a significant product within neuropathic pain and fibromyalgia treatment.
- Market value is about USD 2.5 billion in the US, with steady growth prospects.
- Pricing for brand products has declined post-patent expiry, stabilizing around USD 2.00 per capsule.
- Generic competition has driven prices downward, but current trends show potential for slight increases due to demand and new formulations.
- Future pricing will depend on biosimilar entry, regulatory changes, and market expansion.
FAQs
1. Will the price of pregabalin increase or decrease in the next five years?
Prices are likely to stabilize with minor fluctuations, influenced by biosimilar entry and demand dynamics.
2. How does generic competition impact profit margins for Pfizer?
Generic competition reduces revenue for the original patent holder, but patent expirations also open opportunities for new formulations and other products.
3. Are there any upcoming regulatory changes that could influence market pricing?
Potential biosimilar approvals and regulatory policies aimed at lowering drug costs could intensify price competition.
4. What clinical indications might expand the market for pregabalin?
Emerging evidence supports its use in diabetic peripheral neuropathy and off-label conditions, potentially expanding the patient base.
5. How do reimbursement policies affect drug pricing?
Insurance and government reimbursement influence the actual prices paid, often reducing out-of-pocket costs for patients and affecting manufacturer revenues.
References
[1] IBISWorld. (2022). Neuropathic Pain Market Report.
[2] IQVIA. (2022). US Prescription Drug Market Analysis.
[3] Grand View Research. (2022). Neuropathic Pain Market Size & Trends.
[4] CDC. (2021). Prevalence of Diabetic Neuropathy.
[5] GoodRx. (2022). Pregabalin Price Comparison.
[6] FDA. (2018). Patent and Exclusivity Data for Pfizer's Lyrica.
[7] Anderson, J. (2022). Biologics and Biosimilars Market Overview.
[8] EvaluatePharma. (2023). Drug Price Trends Report.
[9] Pharma Intelligence. (2022). Generic Drug Market Dynamics.
