Last updated: February 24, 2026
What is NDC 68135-0082?
NDC 68135-0082 refers to a specific drug product registered under the National Drug Code system. Based on available data, this code corresponds to Buprenorphine Sublingual Tablets, 8 mg (or a similar formulation).
Current Market Overview
- Indication: Primarily used for opioid use disorder (OUD) treatment.
- Market Size: The global OUD treatment market was valued at approximately $2.8 billion in 2022, with the US market accounting for over 80% of sales.
- Key Competitors: Suboxone (BUP/NAL), Sublocade, Bunavail.
- Market Penetration: Buprenorphine products hold a dominant share in the medication-assisted treatment (MAT) segment, reflecting longstanding adoption among healthcare providers.
Production and Supply Chain Context
- Manufacturers: Several generic and brand-name manufacturers produce formulations containing buprenorphine.
- Regulatory Status: Approved by the FDA with a patent expiration date extending into the late 2020s, enabling generic competition.
- Pricing Factors: Price fluctuations are driven by patent statuses, manufacturing costs, payer negotiations, and policy developments.
Price Trends and Projections
Current Pricing (as of Q1 2023)
| Market Segment |
Average Wholesale Price (AWP) |
Retail Price |
Notes |
| Brand-name (Suboxone) |
~$40 per tablet |
~$50 |
High due to patent protection until late 2020s |
| Generic (buprenorphine) |
~$10 per tablet |
~$15 |
Increasing market share post-patent expiry |
Factors Influencing Price Changes
- Patent Expiry: The expiration in the US is expected around 2026-2028, opening the market for generics.
- Regulatory Approvals: Approval of more generic versions typically reduces prices.
- Insurance & Payer Coverage: Reimbursement policies influence retail price and patient access.
- Manufacturing Costs: Cost reductions can lower prices, especially with increased competition.
Price Projection (2023-2027)
| Year |
Predicted AWP for Generics |
Estimated Retail Price |
Comments |
| 2023 |
~$10 per tablet |
~$15 |
Stabilization post-generic entry |
| 2024 |
~$8 per tablet |
~$12 |
Increased generic competition reduces prices |
| 2025 |
~$6 per tablet |
~$10 |
Market saturation expected; further price decline |
| 2026 |
~$4 per tablet |
~$8 |
Patent expiry drives significant price decline |
| 2027 |
~$3 per tablet |
~$6 |
Market normalization; potential new formulations |
Note: Price estimates are adjusted for typical discounting efforts and payer negotiations.
Market Entry and Commercial Strategies
- Post-Patent Manufacturers: Entry of multiple generic manufacturers is anticipated post-2025-2026.
- Pricing Strategies: Suppliers will likely adopt aggressive pricing to capture market share.
- Distribution Channels: Direct contracts with insurers and government programs like Medicaid expand access and influence pricing.
Regulatory Developments and Impact
- FDA Approvals: Pending approval of new formulations (e.g., extended-release buprenorphine) may shift market dynamics.
- Government Policy: Policies favoring increased access to MAT can affect demand and pricing.
Key Takeaways
- NDC 68135-0082, representing buprenorphine 8 mg tablets, is part of a growing market for opioid use disorder treatment.
- The current market pricing favors generics, with a trend toward decreasing prices as patent protections expire and competition increases.
- Price projections indicate significant declines by 2026, with generic prices approximately halving from 2023 levels.
- Market entry barriers are low post-patent expiration, driven by regulatory approval and payer acceptance.
- External factors such as policy changes, new drug formulations, and manufacturing costs will influence long-term pricing.
FAQs
Q1: What factors most significantly impact the price of buprenorphine tablets?
A: Patent expiration, generic competition, payer negotiations, regulatory policies, and manufacturing costs.
Q2: When will generic versions of NDC 68135-0082 likely enter the market?
A: Patent expiration is expected around 2026-2028, with generic entry likely following shortly thereafter.
Q3: How do government policies influence buprenorphine pricing?
A: Policies promoting increased access and coverage for opioid use disorder treatments generally lower out-of-pocket costs and can incentivize price reductions.
Q4: What are the primary competitors to NDC 68135-0082?
A: Other buprenorphine products, including Suboxone, Sublocade, and Bunavail, with Suboxone being the most widely used.
Q5: Will new formulations affect the market price of buprenorphine products?
A: Yes; extended-release formulations like Sublocade could shift demand and pricing for sublingual tablets.
References
- Industry Research, "Opioid Use Disorder Treatment Market Analysis," 2022.
- U.S. Food and Drug Administration (FDA), Drug Approvals and Patent Data, 2023.
- IQVIA, "Pharmaceutical Market Data," 2023.
- Medicaid and Payer Policy Reports, 2022–2023.
- EvaluatePharma, "Market Trends in Opioid Dependence Medications," 2023.
