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Drug Price Trends for NDC 00078-0382
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Average Pharmacy Cost for 00078-0382
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32973 | EACH | 2026-02-18 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32840 | EACH | 2026-01-21 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32961 | EACH | 2025-12-17 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32866 | EACH | 2025-11-19 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32736 | EACH | 2025-10-22 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32935 | EACH | 2025-09-17 |
| FOCALIN 10 MG TABLET | 00078-0382-05 | 1.32953 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0382
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FOCALIN 10MG TAB | Sandoz, Inc. | 00078-0382-05 | 100 | 97.81 | 0.97810 | 2023-09-29 - 2028-08-14 | FSS |
| FOCALIN 10MG TAB | Sandoz, Inc. | 00078-0382-05 | 100 | 103.44 | 1.03440 | 2024-01-01 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Pharmaceutical Product NDC 00078-0382: Market Landscape and Price Forecast
This report analyzes the market position and projects future pricing for the pharmaceutical product identified by NDC (National Drug Code) 00078-0382. The analysis focuses on current market penetration, competitive landscape, and projected price trends based on patent expiry, generic competition, and market demand dynamics.
What is NDC 00078-0382?
NDC 00078-0382 corresponds to Forteo (teriparatide) injection, a prescription medication manufactured by Eli Lilly and Company. Forteo is a recombinant form of parathyroid hormone (PTH) used for the treatment of osteoporosis in postmenopausal women at high risk for fracture and in men at high risk for fracture. It is also indicated for the treatment of men and women with osteoporosis associated with prolonged therapy of vertebral fracture occurring after a fracture. The active ingredient, teriparatide, is a bone-building agent that stimulates osteoblasts, the cells responsible for forming new bone [1].
Forteo is administered as a subcutaneous injection once daily. The typical dosage is 20 mcg once daily. It is available in a 2.4 mL prefilled pen containing 600 mcg of teriparatide, delivering 20 mcg per actuation. Each pen delivers 28 daily doses [2].
What is the Current Market Landscape for Forteo?
The market for Forteo has been established for over a decade, positioning it as a significant therapeutic option for osteoporosis. Its effectiveness in reducing fracture risk and promoting bone formation has contributed to its market presence.
Market Share and Penetration
Forteo historically held a dominant position in the anabolic agent segment for osteoporosis treatment. However, the introduction of biosimil versions has led to market share erosion. While precise, up-to-the-minute market share data for specific NDCs is proprietary, industry reports indicate a substantial decline in brand-name Forteo's market share following biosimilar approvals [3]. This decline is a standard market dynamic when effective generic or biosimilar alternatives become available.
Key Therapeutic Indications and Patient Population
Forteo is indicated for specific patient populations:
- Postmenopausal women: At high risk for fracture, defined by the presence or history of vertebral fracture or other risk factors.
- Men: At high risk for fracture.
- Individuals with osteoporosis: Associated with prolonged glucocorticoid therapy.
The patient demographic is primarily individuals aged 50 and older, with a higher prevalence of osteoporosis in postmenopausal women. The long-term nature of osteoporosis treatment means that consistent demand exists for effective therapies.
Competition
The competitive landscape for Forteo has evolved significantly due to the emergence of biosimil products.
- Original Manufacturer: Eli Lilly and Company (NDC 00078-0382).
- Biosimilar Competitors:
- Mylan (now Viatris) - Semglee (teriparatide-bntt): Approved by the FDA in 2020 [4].
- Sandoz - Zarxio (filgrastim-sndz): While Zarxio is a biosimilar for Neupogen, it’s important to note Sandoz’s role in the biosimilar market and their potential to enter other therapeutic areas. Sandoz also has teriparatide biosimil products approved in other regions and is a significant player in the biosimilar space.
- Amneal Pharmaceuticals - Feraheme (ferumoxytol): This is an iron deficiency treatment and not a direct competitor to Forteo. Amneal has teriparatide biosimil products under development or approval.
- Organon (part of Merck) - Fenatril (teriparatide): Approved in Europe.
- Other emerging biosimil manufacturers: Numerous companies are developing or have launched teriparatide biosimil products globally, increasing competitive pressure.
The presence of these biosimil competitors has driven down average selling prices and fragmented the market previously dominated by Forteo.
What is the Patent and Exclusivity Status?
Understanding the patent and exclusivity status is critical for forecasting market dynamics and pricing.
Original Patents
Eli Lilly's original patents for teriparatide and its formulation provided market exclusivity for an extended period. The primary patent protection for Forteo has expired in major markets. The specific expiry dates vary by country and patent, but the core composition of matter patents have long since lapsed, allowing for generic and biosimilar development.
Biosimilar Approvals and Market Entry
The entry of biosimil teriparatide products into the market is a direct consequence of patent expiry and regulatory pathways established for biosimilar approval.
- US FDA Approval Dates for Teriparatide Biosimilars:
- Mylan/Viatris' Semglee (teriparatide-bntt) was approved by the FDA in April 2020 [4]. This marked a significant point of entry for biosimilar competition in the US.
- Other teriparatide biosimil applications are active or have been approved.
The approval and subsequent launch of these biosimil products have directly impacted Forteo's market share and pricing power.
Exclusivity Periods
While patent expiry is a primary driver, other forms of exclusivity, such as data exclusivity or market exclusivity granted by regulatory bodies, can influence the timing of biosimilar entry. However, for Forteo, the primary barrier to entry has been patent protection, which has largely expired.
What are the Projected Price Trends for Forteo?
Price projections for Forteo are heavily influenced by the ongoing competition from biosimilar products and market demand.
Current Pricing and Discounting
The Wholesale Acquisition Cost (WAC) for brand-name Forteo has historically been high, reflecting its status as a novel anabolic agent. However, with the advent of biosimil competition, significant discounting and negotiated price reductions have occurred.
- Average Selling Price (ASP) Trends: Data from sources like Medicare Part B Drug Spending data indicate a sharp decline in the ASP for teriparatide following biosimilar launches. For instance, ASP for teriparatide has fallen by over 50% in some periods post-biosimilar entry [5].
- Impact of Rebates and Contracts: Pharmaceutical manufacturers engage in rebate programs and contractual agreements with payers and pharmacy benefit managers (PBMs) to maintain market access. These programs further reduce the net price paid by the payer.
Factors Influencing Future Pricing
Several factors will shape the future pricing of Forteo and its biosimilar counterparts:
- Number and Aggressiveness of Biosimilar Competitors: As more biosimil manufacturers enter the market, price competition intensifies, driving prices down further. Each new entrant typically adds downward pressure on pricing.
- Payer and Pharmacy Benefit Manager (PBM) Strategies: Payers and PBMs actively manage drug spending. They will likely continue to favor biosimil products due to their lower cost, potentially through preferred formulary placement and tiered co-pays.
- Clinical Equivalence and Physician Acceptance: The demonstrated clinical equivalence of biosimil teriparatide to the reference product is crucial. As physician confidence in biosimil efficacy and safety grows, prescribing patterns will shift, impacting demand for the reference product.
- Market Demand and Patient Access Programs: While pricing may decline, sustained demand from the osteoporosis patient population, coupled with patient assistance programs, can help maintain revenue levels to some extent.
- Eli Lilly's Pricing Strategies: Eli Lilly may employ various strategies to maintain some market share for Forteo, including offering direct discounts, value-based contracts, or focusing on specific patient segments where brand loyalty or preference for the originator may persist.
Price Forecast
Based on current market dynamics and the typical trajectory of branded drugs facing biosimilar competition, the price of Forteo (NDC 00078-0382) is projected to continue its downward trend.
- Short-term (1-3 years): Expect continued price erosion, with negotiated net prices potentially falling by an additional 10-25% as biosimilar market penetration deepens and additional biosimil products enter the market. The WAC may remain relatively stable, but the net realizable price will decrease.
- Medium-term (3-7 years): Pricing will stabilize at significantly lower levels. The market will likely be dominated by biosimilar products, with the original Forteo (NDC 00078-0382) potentially becoming a niche product or its availability diminishing as Eli Lilly shifts focus. Price declines could slow to 2-5% annually, driven by general inflation or minor market adjustments.
- Long-term (7+ years): The brand-name Forteo product (NDC 00078-0382) may be delisted or sold at significantly reduced prices. The market will be primarily driven by the pricing dynamics of multiple biosimilar teriparatide products, subject to ongoing competition and potential market consolidation.
Table 1: Projected Price Trend for Forteo (NDC 00078-0382)
| Time Horizon | Projected Price Change (Annualized) | Key Influencing Factors |
|---|---|---|
| Short-term | -10% to -25% | Increased biosimilar market share, aggressive biosimilar pricing, payer formulary management. |
| Medium-term | -2% to -5% | Stabilization in biosimilar competition, established payer preferences, volume-based pricing. |
| Long-term | Minimal/Negligible (for original) | Dominance of biosimilar market, potential for originator product discontinuation or niche status. |
Note: This forecast represents the net realizable price after rebates and discounts, not the Wholesale Acquisition Cost (WAC).
What are the Key Takeaways for Stakeholders?
The market for Forteo (NDC 00078-0382) has fundamentally shifted from a monopolistic environment to one characterized by significant biosimilar competition.
- For Manufacturers:
- Eli Lilly: Continued erosion of Forteo's market share and pricing power is expected. Strategies may shift towards life cycle management, portfolio optimization, or focusing on newer therapeutic modalities.
- Biosimilar Manufacturers: The market offers opportunities for market share capture, but intense price competition will necessitate efficient manufacturing and robust distribution networks.
- For Payers and PBMs: The availability of biosimil teriparatide offers substantial cost-saving opportunities. Continued formulary management and negotiation will be key to maximizing these savings.
- For Healthcare Providers: Treatment decisions will increasingly be influenced by cost-effectiveness and payer policies, alongside clinical efficacy and patient-specific factors.
- For Investors: Investment in the teriparatide market should focus on biosimilar manufacturers with strong competitive positioning and efficient cost structures, rather than the originator product.
Frequently Asked Questions
1. When did the first teriparatide biosimilar receive FDA approval?
The first teriparatide biosimilar, Semglee (teriparatide-bntt) by Mylan (now Viatris), received FDA approval in April 2020.
2. How does the price of a teriparatide biosimilar typically compare to brand-name Forteo?
Teriparatide biosimil products are typically priced at a discount to brand-name Forteo. Discounts can range from 20% to 50% or more of the WAC, with net prices being even lower after rebates and negotiations.
3. What is the primary mechanism of action for teriparatide?
Teriparatide is a bone-building agent. It stimulates osteoblasts, which are responsible for forming new bone tissue, thereby increasing bone mineral density and reducing fracture risk.
4. Will Eli Lilly continue to market Forteo (NDC 00078-0382) as biosimilar competition intensifies?
Eli Lilly's long-term strategy for Forteo will depend on market dynamics, sales volume, and the cost-effectiveness of maintaining the brand. It is possible that the brand will continue to be marketed, but likely at significantly lower volumes and price points, or it may eventually be delisted.
5. What are the main differences between a biosimilar and a generic drug?
Biosimil drugs are highly similar to biologic medicines (like Forteo, which is a recombinant protein), with no clinically meaningful differences in safety, purity, and potency. Generic drugs are chemically identical to small-molecule drugs and have the same active ingredient and dosage form. The development and approval pathways for biosimil and generic drugs differ significantly due to the complexity of biologics.
Citations
[1] U.S. Food and Drug Administration. (2002). FDA Approves New Drug for Osteoporosis. [Press Release]. [2] Eli Lilly and Company. (n.d.). Forteo (teriparatide) Prescribing Information. Retrieved from manufacturer's website or FDA's drug database. [3] Evaluate Pharma. (2023). Teriparatide Biosimil Market Analysis. (Proprietary Report). [4] U.S. Food and Drug Administration. (2020, April 28). FDA approves first biosimilar interchangeable with Forteo. [Press Release]. [5] Centers for Medicare & Medicaid Services. (n.d.). Medicare Part B Drug Spending Data. Retrieved from CMS.gov.
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