Last updated: February 23, 2026
What is NDC 00955-1016?
NDC 00955-1016 identifies a prescription drug listed under the National Drug Code system. This specific code corresponds to Aubagio (teriflunomide), an oral disease-modifying therapy (DMT) approved for relapsing forms of multiple sclerosis (MS). It is marketed primarily by Sanofi and was approved by the FDA in September 2012.
Market Overview
Clinical Indications and Adoption
Aubagio is used to reduce the frequency of MS relapses and slow disability progression. It is one of several oral therapies in a competitive landscape that includes Gilead’s Vumerity, Biogen’s Tecfidera, and Novartis’s Mayzent.
Market Size and Growth
The global MS drug market was valued at approximately $22 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 5.5% from 2023 to 2030, driven by increased diagnosis rates, expanded indications, and ongoing R&D efforts [1].
In the U.S., the MS drug market is around $8 billion, with oral therapies representing roughly 60% of prescriptions. Aubagio accounts for approximately 10-12% of the oral MS market share, with annual sales close to $400 million as of 2022 [2].
Competitive Environment
Market competition includes:
- Tecfidera (dimethyl fumarate): Market leader in oral MS drugs.
- Mayzent (siponimod) by Novartis.
- Vumerity (diroximel fumarate): Gilead Sciences.
- Gilenya (fingolimod): First oral DMT, now declining in market share.
Share shifts are influenced by efficacy profiles, side effects, dosing convenience, and safety concerns.
Price Trends and Projections
Current Pricing
The wholesale acquisition cost (WAC) of Aubagio in the U.S. stands at approximately $7,500 per 28-day supply. Insurance rebates and discounts reduce net prices, but list prices are often used as the basis for market analysis.
Past Price Movements
Between 2014 and 2022, Aubagio's list price increased annually by an average of 3%. Price inflation aligned with general healthcare inflation but was mitigated by patent protections and brand positioning.
Future Price Projections
Several factors will influence future pricing:
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Patent Status: Aubagio's patent expired in 2018 in the U.S. [3], opening the door to generic competition. No generic versions have been fully launched yet, though multiple companies have submitted abbreviated new drug applications (ANDAs).
-
Market Entry of Generics: Predicted to occur between 2024 and 2025. Once generics enter, list prices are expected to decline by 40-60%, based on historical generics price erosion data [4].
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Price Policy Trends: CMS and private insurers aim to reduce drug prices. The introduction of biosimilars and generics often precipitates rapid price reductions.
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Rebate and Discount Dynamics: Greater rebate pressures may lead to net prices dropping faster than list prices.
Price Projections (2023-2030)
| Year |
Estimated List Price (per 28-days) |
Notes |
| 2023 |
$7,500 |
Stable, before generic entry |
| 2024 |
$6,750–$7,125 (expected decline) |
Anticipated generic launch; 10-15% reduction |
| 2025 |
$4,500–$5,250 (post-generic) |
Reduced further with increased competition |
| 2026–2030 |
$3,600–$4,200 |
Stabilization, assuming no new formulations or policies |
Market Entry and Regulatory Hurdles
Generic Approval Pathway
The FDA has approved multiple ANDAs for teriflunomide. No generic has yet been marketed, but once approved, pricing will decline substantially.
Patent Litigation and Market Dynamics
Patent litigation delays can extend exclusivity beyond 2018, but patent challenges have resulted in earlier generic approvals in other jurisdictions.
Key Market Drivers
- Increased diagnosis: Growing awareness and improved diagnostic techniques.
- Patient preferences: Transition to oral DMTs over injectables.
- Pricing strategies: Payers seeking to negotiate discounts and rebates.
Risks and Barriers
- Patent challenges and IP litigation.
- Price reductions due to generics or biosimilars.
- Market saturation: The emergence of newer DMTs with better efficacy or safety profiles.
- Regulatory changes: Policy shifts targeting drug pricing.
Key Takeaways
- NDC 00955-1016 corresponds to Aubagio, an oral MS drug with significant market presence since 2012.
- U.S. list prices are about $7,500/month, with a market share of ~10-12%.
- The upcoming entry of generics planned between 2024 and 2025 will induce steeper price declines.
- The global MS drug market is growing at a CAGR of 5.5%, but the segment for Aubagio will likely see price erosion as generics proliferate.
- Payers and policymakers are increasingly influencing net prices through rebates and formulary management.
FAQs
Q1: When will generic versions of Aubagio become available?
A1: Generic approval is anticipated between 2024 and 2025, following patent expiration and competition.
Q2: How much will prices drop with generic entry?
A2: List prices may fall by 40-60%, depending on market competition and rebate arrangements.
Q3: What is the current market share of Aubagio among oral MS therapies?
A3: Approximately 10-12% in the U.S., with ongoing competition.
Q4: Are there significant pipeline developments for Aubagio?
A4: No new formulations or indications are publicly announced; market dynamics depend mainly on generic entry.
Q5: How do policy changes affect drug pricing for MS therapies?
A5: Policies aiming to control healthcare costs may accelerate price reductions via rebates, formulary restrictions, and increased generic uptake.
References
[1] Grand View Research. (2023). Multiple Sclerosis Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). National Prescription Audit.
[3] FDA. (2018). Patent Expiry Details for Aubagio.
[4] IMS Health. (2021). Generic Drug Pricing Trends.
