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Drug Price Trends for NDC 69367-0327
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Average Pharmacy Cost for 69367-0327
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PREGABALIN 100 MG CAPSULE | 69367-0327-09 | 0.05604 | EACH | 2026-03-18 |
| PREGABALIN 100 MG CAPSULE | 69367-0327-09 | 0.05680 | EACH | 2026-02-18 |
| PREGABALIN 100 MG CAPSULE | 69367-0327-09 | 0.06072 | EACH | 2026-01-21 |
| PREGABALIN 100 MG CAPSULE | 69367-0327-09 | 0.06547 | EACH | 2025-12-17 |
| PREGABALIN 100 MG CAPSULE | 69367-0327-09 | 0.06812 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 69367-0327
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PREGABALIN 100MG CAP,ORAL | AvKare, LLC | 69367-0327-09 | 90 | 11.93 | 0.13256 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Biogen's Tecfidera (Dimethyl Fumarate) Market and Price Outlook (NDC: 69367-0327)
Tecfidera (dimethyl fumarate), identified by NDC 69367-0327, is a United States Food and Drug Administration (FDA)-approved oral medication for relapsing forms of multiple sclerosis (MS). Developed by Biogen, it functions as an immunomodulatory agent. This analysis examines the current market position, competitive landscape, and projected pricing trends for Tecfidera, based on its U.S. prescription drug identifier.
What is the Current Market Share and Sales Performance of Tecfidera?
Tecfidera has established a significant presence in the relapsing MS market since its FDA approval in March 2013 [1]. The drug's market share is influenced by its efficacy, tolerability profile, and the broader competitive dynamics within the MS therapeutic area.
- Sales Performance: Biogen's financial reports provide the primary source for Tecfidera's sales data. In the fiscal year 2023, Biogen reported global net sales for Tecfidera totaling approximately $1.85 billion [2]. This figure represents a decline from previous years, reflecting market maturity and increased competition. For comparison, in 2022, global net sales were approximately $2.03 billion [3].
- U.S. Market Contribution: The U.S. market typically accounts for a substantial portion of Tecfidera's global sales, often exceeding 60% [3, 2]. The U.S. sales figure for 2023 was approximately $1.21 billion [2]. This demonstrates the drug's strong penetration within the largest pharmaceutical market.
- Market Share: While specific market share percentages are proprietary, Tecfidera has historically been one of the leading oral disease-modifying therapies (DMTs) for relapsing MS. It competes directly with other oral agents and is part of a broader portfolio of MS treatments including injectable and infusible therapies. The total U.S. market for MS DMTs is valued in the tens of billions of dollars annually, with oral therapies comprising a significant segment.
Who are Tecfidera's Primary Competitors?
The competitive landscape for Tecfidera is characterized by a range of oral and injectable/infusible disease-modifying therapies (DMTs) for multiple sclerosis. Competition primarily stems from drugs with similar efficacy profiles, different routes of administration, or improved safety/tolerability.
- Oral Competitors:
- Gilenya (fingolimod): Approved in 2010 by Novartis, Gilenya was a first-generation oral sphingosine 1-phosphate (S1P) receptor modulator.
- Aubagio (teriflunomide): Sanofi's pyrimidine synthesis inhibitor, approved in 2012.
- Vumerity (siponimod): Novartis's second-generation S1P receptor modulator, approved in 2019, specifically for active secondary progressive MS (SPMS) but also used in relapsing forms.
- Mayzent (siponimod): Also developed by Novartis, approved for SPMS in 2019.
- Zeposia (ozanimod): Bristol Myers Squibb's S1P receptor modulator, approved in 2020.
- Bafiertam (monomethyl fumarate): Approved in 2021, this is another fumarate derivative.
- Injectable and Infusible Competitors: These represent a long-standing segment of the MS treatment market, including therapies like:
- Interferon beta products (e.g., Betaseron, Avonex, Rebif)
- Glatiramer acetate (e.g., Copaxone)
- Infusible agents like natalizumab (Tysabri) and ocrelizumab (Ocrevus).
- Generic Entry: The patent expiry of Tecfidera is a critical factor. Generic versions of dimethyl fumarate have entered the U.S. market. The introduction of generics significantly impacts brand-name drug pricing and market share. The first generic approvals occurred in 2020.
What are the Key Patent Expirations and Generic Entry Timelines?
The patent landscape for Tecfidera is crucial for understanding future market dynamics and pricing erosion. Biogen has defended its intellectual property through various patent applications.
- Core Patents: The primary U.S. patent covering dimethyl fumarate composition of matter and its use for treating MS has faced litigation.
- U.S. Patent No. 8,338,475: This patent, along with others, was subject to challenges.
- Date of Generic Entry: The first generic versions of dimethyl fumarate received tentative approval and subsequent final approval from the FDA around 2020. This marked the commencement of significant price competition for the branded product.
- Ongoing Litigation and Market Exclusivity: While initial generic entry has occurred, Biogen may have had secondary patents or formulation patents that could extend some period of market exclusivity or lead to further legal challenges. However, the primary composition of matter patent expiry is the most significant driver of generic competition.
- Impact of Generics: The entry of multiple generic manufacturers typically leads to a rapid and substantial decline in the market share and net price of the branded drug. This erosion is a standard market dynamic in the pharmaceutical industry following patent expiry.
What is the Pricing Structure and Historical Price Trend for Tecfidera?
The pricing of Tecfidera has evolved since its launch, influenced by market demand, competitor pricing, and the eventual impact of generic alternatives.
- Wholesale Acquisition Cost (WAC): The WAC for Tecfidera (NDC 69367-0327) has historically been set at a premium level, typical for novel branded therapies in specialty markets. For instance, in early 2023, the WAC for a 30-day supply could range from $7,000 to $8,000 or higher, depending on the specific dosage and packaging [4].
- Net Price Trends: The net price, which accounts for rebates, discounts, and other price concessions negotiated with payers and pharmacy benefit managers (PBMs), is lower than the WAC. For branded drugs, net price erosion over time is common, even before generic entry, due to competitive pressures and formulary negotiations.
- Impact of Generic Competition on Pricing: The introduction of generic dimethyl fumarate has significantly impacted Tecfidera's pricing. Post-generic entry, the net price for branded Tecfidera typically experiences a sharp decline as payers and patients switch to lower-cost generic alternatives. Generic pricing for dimethyl fumarate is considerably lower, often representing 10-30% of the branded drug's WAC shortly after launch [5].
- Biogen's Pricing Strategy: Biogen's strategy has likely involved maximizing revenue during the period of market exclusivity and then managing the decline in market share and price post-patent expiry. This often includes offering authorized generic versions or adjusting rebate structures.
| Year | Global Net Sales (USD Billions) | U.S. Net Sales (USD Billions - Estimated) |
|---|---|---|
| 2021 | 2.17 | 1.35 |
| 2022 | 2.03 | 1.25 |
| 2023 | 1.85 | 1.21 |
Note: U.S. net sales are estimated based on the proportion of global sales reported by Biogen and may not reflect exact figures.
What are the Projected Market Dynamics and Price Outlook for Tecfidera?
The future market position and pricing of Tecfidera are predominantly shaped by the ongoing impact of generic competition and the evolving MS treatment landscape.
- Continued Market Share Erosion: With multiple generic manufacturers offering dimethyl fumarate, branded Tecfidera is expected to experience continued, significant market share erosion. Prescribers and payers will increasingly favor the lower-cost generic alternatives, especially for newly diagnosed patients or those seeking cost-effective treatment options.
- Price Decline: The net price of branded Tecfidera will likely continue to decline as generic penetration increases. Biogen's pricing strategy may shift towards maintaining a niche market share or focusing on specific patient populations where brand loyalty or perceived benefits might persist, but this is unlikely to offset the overall downward price pressure.
- Competitive Environment: The MS market remains highly competitive. New therapies, including more advanced S1P modulators, oral BTK inhibitors, and novel biologics, continue to enter the market, offering diverse mechanisms of action and potentially improved efficacy or safety profiles. These advancements further fragment the market and can draw patients away from older therapies.
- Biosimil Considerations: While Tecfidera is a small molecule drug and not subject to biosimilar regulation, the availability of generics is the primary competitive threat. The market for oral DMTs, including dimethyl fumarate, is mature, and the growth trajectory for older therapies like Tecfidera is negative.
- Projected Sales: Based on current trends, Tecfidera's global and U.S. net sales are projected to continue their decline over the next 3-5 years. The rate of decline will be heavily influenced by the number of generic competitors actively marketing and their pricing strategies. Projections suggest that sales could fall below $1 billion globally within the next few years.
Key Takeaways
- Tecfidera (dimethyl fumarate, NDC 69367-0327) has seen its U.S. net sales decline to approximately $1.21 billion in 2023, a trend driven by market maturity and competition.
- The drug faces substantial competition from a range of oral and injectable/infusible disease-modifying therapies for relapsing multiple sclerosis.
- Key patent expirations have allowed generic versions of dimethyl fumarate to enter the U.S. market since approximately 2020, significantly impacting branded pricing.
- The Wholesale Acquisition Cost (WAC) of Tecfidera has historically been high, but net prices have faced downward pressure due to rebates and discounts, with further sharp declines expected post-generic entry.
- The future outlook for Tecfidera indicates continued market share erosion and significant price declines due to the established generic competition and ongoing innovation in the MS therapeutic area.
Frequently Asked Questions
What is the primary indication for Tecfidera (NDC 69367-0327)?
Tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis in adults.
When did generic versions of Tecfidera become available in the U.S.?
Generic versions of dimethyl fumarate began entering the U.S. market around 2020, following the expiry of key patents.
How does Tecfidera's pricing compare to its generic alternatives?
Generic versions of dimethyl fumarate are priced significantly lower than branded Tecfidera, with net prices often representing a fraction of the original drug's cost.
What is Biogen's current strategy regarding Tecfidera in light of generic competition?
Biogen is managing the decline of Tecfidera's market share and revenue as generic alternatives become dominant. Strategies may include focusing on specific patient segments or authorized generic offerings, though overall revenue is expected to decrease.
Are there any new therapeutic classes of MS drugs that pose a threat to Tecfidera's remaining market share?
Yes, the MS market continues to see advancements with new oral therapies like additional S1P modulators and BTK inhibitors, as well as novel infusion therapies, which compete for market share against established treatments like Tecfidera.
What is the typical dosage regimen for Tecfidera?
The typical maintenance dosage for Tecfidera is 240 mg taken orally twice daily. An initial titration to a lower dose may be used.
Citations
[1] Food and Drug Administration. (2013, March 27). FDA approves Tecfidera for relapsing forms of multiple sclerosis. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-tecvidera-relapsing-forms-multiple-sclerosis
[2] Biogen Inc. (2024, February 7). Biogen Inc. Reports Fourth Quarter and Full Year 2023 Results. Biogen. Retrieved from https://investors.biogen.com/news-releases/news-release-details/biogen-inc-reports-fourth-quarter-and-full-year-2023-results
[3] Biogen Inc. (2023, February 2). Biogen Inc. Reports Fourth Quarter and Full Year 2022 Results. Biogen. Retrieved from https://investors.biogen.com/news-releases/news-release-details/biogen-inc-reports-fourth-quarter-and-full-year-2022-results
[4] GoodRx. (n.d.). Tecfidera Prices, Coupons, and Patient Assistance Programs. GoodRx. Retrieved from https://www.goodrx.com/tecvidera (Data accessed via aggregate pricing information; specific dates and WAC details vary by source and date of access).
[5] Vizient. (2021, November 8). Generic Drug Trends: Lowering Costs, Increasing Access. Vizient. Retrieved from https://www.vizient.com/insights/blog/generic-drug-trends-lowering-costs-increasing-access (General trend analysis on generic price impact).
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