Last updated: February 14, 2026
What is NDC 25021-0813?
NDC 25021-0813 identifies Xyban (bupropion hydrochloride) sustained-release tablets, 150 mg. It is marketed primarily for smoking cessation. Manufacturers include GlaxoSmithKline, with approval in multiple countries, including the U.S., since 1997.
What is the current market landscape?
Market Size and Demand
- The global smoking cessation market reached approximately $3.1 billion in 2021, projected to grow at a CAGR of 6.2% through 2028 [1].
- In the U.S. alone, an estimated 40 million adult smokers exist; about 7% attempt to quit annually [2].
- Bupropion-based therapies account for roughly 25% of prescription smoking cessation interventions in the U.S. [3].
Competitive Environment
- Key competitors include varenicline (Chantix), nicotine replacement therapies (patches, gums), and other off-label medications.
- GSK's market share for bupropion products (including NDC 25021-0813) is estimated at 45% among prescription smoking cessation drugs in the U.S. [3].
What are the regulatory and patent considerations?
- U.S. patents protecting formulations or delivery methods expired around 2018, allowing generic manufacturers entry.
- Several generics are available, reducing brand exclusivity and impacting pricing.
- Regulatory status remains stable with no recent restrictions; off-label uses include depression treatment, broadening the drug’s indications.
What are the current and projected pricing trends?
Current Pricing
- Retail prices for a 30-day supply of 150 mg sustained-release tablets fluctuate between $330 and $440 wholesale cost, depending on purchasing channels.
- Generic versions typically retail at 20-30% below brand name prices.
Price Projections
- As patent protections dissolve, expect prices to decline by approximately 10-15% annually over the next 3-5 years owing to increased generic competition.
- Anticipate stable wholesale acquisition costs (WAC) for generic bupropion sustained-release formulations around $200-$250 annually for the typical course.
- Premium formulations or branded versions may retain higher prices, but face pressure from generics.
What are the key factors influencing future market dynamics?
- Generics: Increased generic entries will push prices downward.
- Insurance Coverage: Reimbursement policies influence affordability and prescribing patterns.
- New Indications: Emerging research on off-label benefits could alter demand.
- Market Penetration: Expansion into emerging markets could increase overall volume but may suppress price growth further due to local price sensitivities.
Summary
NDC 25021-0813, primarily representing the GSK marketed formulation of bupropion hydrochloride sustained-release 150 mg, operates in a competitive, mature market. The expiration of patent rights has introduced generics, driving prices downward. Wholesale prices are expected to decrease 10-15% annually over the next 3-5 years, constrained by growing generic supply and market saturation.
Key Takeaways
- The product faces stiff competition from generics, which dominate U.S. prescription volumes.
- Price declines are predictable, averaging 10-15% annually as patent protections lapse.
- Market growth is driven by smoking cessation demand, but volume increases may be offset by pricing pressures.
- Insurance reimbursement and emerging indications could influence future demand and pricing.
FAQs
1. Will the price of NDC 25021-0813 rise again in the future?
Price increases are unlikely in the near term due to increasing generic competition and market saturation. Any future increase would depend on new patent protections or formulations.
2. How does generic competition affect the product’s market share?
Generics hold the majority share, reducing the market share of brand-name formulations. Brand-name sales decline as generics become more prevalent.
3. Are there regulatory barriers that could affect pricing?
No recent regulatory restrictions are observed; regulatory stability typically sustains the current market environment.
4. Could new formulations or delivery mechanisms impact pricing?
Yes, innovative delivery systems or combination therapies could command premium prices, but no such developments are currently confirmed for NDC 25021-0813.
5. What are the primary factors influencing future demand?
Key factors include smoking cessation trends, insurance coverage policies, and the development of new indications for bupropion.
References
[1] MarketsandMarkets. "Smoking Cessation Market by Product, Distribution Channel, and Region," 2022.
[2] CDC. "Adult Cigarette Smoking in the United States," 2021.
[3] IMS Health. "Prescription Drug Market Share Analysis," 2022.
