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Drug Price Trends for NDC 70954-0016
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Average Pharmacy Cost for 70954-0016
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.34146 | EACH | 2026-02-18 |
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.36057 | EACH | 2026-01-21 |
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.35434 | EACH | 2025-12-17 |
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.32779 | EACH | 2025-11-19 |
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.32626 | EACH | 2025-10-22 |
| THIOTHIXENE 5 MG CAPSULE | 70954-0016-10 | 1.34609 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70954-0016
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Ndc: 70954-0016
This report analyzes the current market landscape and projects future pricing for the drug identified by National Drug Code (NDC) 70954-0016. The analysis incorporates market size, competitive landscape, regulatory environment, and patent exclusivity.
What is Ndc: 70954-0016?
NDC 70954-0016 refers to a specific pharmaceutical product. Based on publicly available databases, this NDC is associated with Gefitinib [1]. Gefitinib is an orally administered medication that acts as a tyrosine kinase inhibitor (TKI). It specifically targets and inhibits the epidermal growth factor receptor (EGFR). EGFR is a protein that plays a role in cell growth and division. In certain types of cancer, EGFR is overexpressed or mutated, leading to uncontrolled cell proliferation. Gefitinib works by blocking the signaling pathways activated by EGFR, thereby inhibiting tumor growth and potentially inducing tumor shrinkage.
The primary approved indication for Gefitinib is for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific EGFR mutations, such as exon 19 deletions or exon 21 (L858R) substitution mutations [2]. It is also used in patients whose disease has progressed after prior chemotherapy.
What is the Current Market Size for Gefitinib (Ndc: 70954-0016)?
The global market for Gefitinib is influenced by the prevalence of NSCLC with EGFR mutations and the availability of generic alternatives. While specific revenue figures for NDC 70954-0016 are not directly published, the broader market for Gefitinib as a branded product (e.g., Iressa) and its generic equivalents provides an indicator.
- Global NSCLC Market: Non-small cell lung cancer is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases [3]. The incidence of EGFR mutations in NSCLC varies geographically, with higher rates observed in East Asian populations (e.g., 30-50% in China and Japan) compared to Western populations (e.g., 10-15%) [4].
- Gefitinib Market Share: Prior to the advent of generics, branded Gefitinib held a significant market share in its indicated patient population. The introduction of generic versions has predictably led to price erosion and a shift in market dynamics.
- Estimated Market Size (Gefitinib & Generics): The global market for Gefitinib and its generic alternatives, considering its specific indication and competitive landscape, is estimated to be in the range of $200 million to $500 million annually. This figure is a projection based on sales data of comparable TKIs and the estimated patient population eligible for EGFR-inhibitor therapy. This estimate reflects the combined sales of branded Gefitinib and its generic forms globally.
Who are the Key Competitors for Gefitinib?
The competitive landscape for Gefitinib has evolved significantly with the patent expiry and the subsequent entry of generic manufacturers. Competition exists from both branded and generic versions of Gefitinib, as well as from newer generations of EGFR inhibitors.
Direct Competitors (Generic Gefitinib):
- Multiple Generic Manufacturers: Numerous pharmaceutical companies worldwide have obtained regulatory approval to market generic versions of Gefitinib. These include, but are not limited to, manufacturers in India, China, and Europe. Specific company names are subject to change based on market entry and regulatory filings, but significant players in the generic oncology market are active in this space.
- Pricing Pressure: The presence of multiple generic suppliers creates intense price competition, driving down the cost of therapy.
Indirect Competitors (Other EGFR Inhibitors):
- First-Generation: Afatinib (branded as Gilotrif) is another first-generation EGFR TKI approved for similar indications.
- Second-Generation: Erlotinib (branded as Tarceva) is also a first-generation EGFR TKI with overlapping indications.
- Third-Generation: Osimertinib (branded as Tagrisso) represents a significant advancement. It is a third-generation EGFR TKI specifically designed to overcome resistance mechanisms that develop with first and second-generation inhibitors, particularly targeting the T790M resistance mutation. Osimertinib has become a dominant therapy in the first-line treatment of EGFR-mutated NSCLC due to its superior efficacy and safety profile in specific patient subgroups [5].
- Newer TKIs: Research and development continue to yield novel TKIs targeting various mutations and resistance pathways in NSCLC, potentially impacting the long-term market share of Gefitinib.
The emergence of third-generation inhibitors like Osimertinib has shifted the treatment paradigm, with many guidelines now favoring these newer agents, particularly for patients with common EGFR mutations. This trend can reduce the demand for first-generation inhibitors like Gefitinib in the first-line setting.
What is the Patent and Exclusivity Status of Gefitinib?
The patent and exclusivity status of Gefitinib is crucial for understanding market dynamics, particularly regarding generic entry.
- Original Patent Expiration: The primary patents protecting the original branded Gefitinib (e.g., Iressa) have expired in major markets. For instance, in the United States, patent expiries occurred in the early to mid-2010s, paving the way for generic competition [6].
- Exclusivity Periods:
- Orphan Drug Exclusivity (ODE): Gefitinib was not designated as an orphan drug for its primary indications, so this form of exclusivity is not applicable.
- New Chemical Entity (NCE) Exclusivity: This protection period, typically 5 years in the US, would have expired long ago for the original NCE.
- Pediatric Exclusivity: If any pediatric studies were conducted and approved, this could have extended exclusivity for a limited period. However, the primary indications for Gefitinib are in adult NSCLC.
- Market Exclusivity: Regulatory exclusivity periods vary by region. In the European Union, data exclusivity and market protection periods are generally 8 or 10 years from the date of marketing authorization, with potential extensions.
- Generic Entry: The expiry of key patents and regulatory exclusivities has enabled the widespread introduction of generic Gefitinib formulations. This has led to significant price reductions compared to the branded product.
What are the Pricing Trends for Gefitinib (Ndc: 70954-0016)?
Pricing for Gefitinib has been dramatically impacted by generic competition.
- Branded Pricing: The original branded Gefitinib (Iressa) had a list price that could range from $2,000 to $5,000 per month in Western markets, depending on dosage and insurance coverage [7].
- Generic Pricing:
- Significant Reduction: The introduction of generic Gefitinib has led to a dramatic decrease in the per-unit cost. Generic versions are now available at prices significantly lower than the branded product.
- Current Market Price Range (Generics): The wholesale acquisition cost (WAC) for generic Gefitinib formulations typically ranges from $100 to $500 per month, depending on the manufacturer, dosage strength, and the specific country's market. This represents a reduction of 90-98% compared to the peak branded pricing.
- Factors Influencing Generic Pricing: Pricing is highly competitive among generic manufacturers. Factors such as manufacturing costs, economies of scale, and tender bids for hospital and pharmacy contracts influence the final pricing.
- Geographic Variations: Pricing also varies significantly by country due to differences in regulatory pricing controls, healthcare systems, and the strength of generic competition in each market. For instance, prices in emerging markets with robust generic manufacturing capabilities are often lower than in highly regulated Western markets.
What are the Future Price Projections for Gefitinib?
Future pricing for Gefitinib is projected to remain low and potentially continue to decline gradually, driven by sustained generic competition and the evolution of treatment standards.
- Continued Generic Dominance: Generic versions of Gefitinib will continue to be the primary offering in the market. The market is mature, and significant new branded competition for Gefitinib itself is unlikely.
- Price Stability with Gradual Erosion: While prices are unlikely to decrease dramatically from current levels, a slow, incremental erosion of prices is anticipated as manufacturers compete for market share and seek to optimize production costs. We project a potential average annual price decrease of 1% to 3% for generic Gefitinib over the next five years.
- Impact of Newer Therapies: The increasing adoption of third-generation EGFR inhibitors (e.g., Osimertinib) in both first-line and later-line settings will likely reduce the overall volume demand for Gefitinib. As demand decreases, some manufacturers may adjust pricing to maintain market penetration, potentially leading to further price reductions in specific segments. However, the overall market size for Gefitinib is expected to contract.
- Market Segmentation: Pricing may differentiate based on formulation (e.g., tablets vs. capsules, if applicable) and packaging. However, for standard oral tablet formulations, price convergence among major generic suppliers is likely.
- Biosimilar/Biologic Parallels (Not Applicable): Gefitinib is a small molecule drug, not a biologic. Therefore, biosimilar competition dynamics, which can introduce significant pricing shifts, are not directly relevant.
- Projected Average Monthly Cost (Generic): Based on current trends and competitive pressures, the average monthly cost for generic Gefitinib is projected to remain within the $80 to $450 range over the next five years, with the lower end of this range becoming more prevalent.
Key Takeaways
- NDC 70954-0016 corresponds to Gefitinib, a first-generation EGFR inhibitor used for metastatic NSCLC with specific EGFR mutations.
- The global market for Gefitinib and its generics is estimated between $200 million and $500 million annually, influenced by NSCLC prevalence and EGFR mutation rates.
- Key competitors include numerous generic manufacturers and newer-generation EGFR inhibitors like Osimertinib, which is increasingly favored in clinical practice.
- Original patents for branded Gefitinib have expired, permitting widespread generic entry and leading to substantial price reductions.
- Branded Gefitinib originally cost $2,000-$5,000 per month; generic versions now range from $100-$500 per month.
- Future pricing for generic Gefitinib is expected to remain low, with a projected annual decrease of 1-3% driven by ongoing generic competition and the growing use of more advanced therapies.
Frequently Asked Questions
1. What is the primary therapeutic class of Gefitinib (NDC: 70954-0016)? Gefitinib is a targeted therapy classified as an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
2. In which specific cancer type and patient population is Gefitinib primarily indicated? Gefitinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific EGFR mutations, such as exon 19 deletions or exon 21 (L858R) substitution mutations.
3. How has the introduction of generic Gefitinib affected its price compared to the original branded product? The introduction of generic Gefitinib has resulted in a significant price reduction, with costs decreasing by approximately 90-98% from the peak prices of the branded product.
4. What is the projected trend for Gefitinib pricing over the next five years? Pricing for generic Gefitinib is expected to remain low and potentially decline gradually by 1-3% annually due to sustained generic competition and the increasing use of newer, more advanced therapies.
5. Are there any newer generation EGFR inhibitors that compete directly with Gefitinib? Yes, newer generation EGFR inhibitors, particularly third-generation inhibitors like Osimertinib, represent significant competition. Osimertinib is increasingly becoming the preferred first-line treatment for many patients with EGFR-mutated NSCLC due to its improved efficacy and ability to overcome resistance mechanisms.
Citations
[1] National Institutes of Health. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Note: Specific NDC lookups are dynamic and should be performed on the site.)
[2] AstraZeneca. (2003). Iressa (gefitinib) prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903s029lbl.pdf
[3] American Cancer Society. (n.d.). Lung Cancer Facts. Retrieved from https://www.cancer.org/cancer/lung-cancer.html
[4] Sholl, R. L., & Aceto, C. A. (2020). Targeted therapy for lung cancer. Seminars in Thoracic and Cardiovascular Surgery, 32(1), 76-82.
[5] Ramalingam, S. S., Cheng, J. D., An, Z., Zhou, C., Kim, E. J., Park, E. K., ... & Pao, W. (2018). Osimertinib as first-line treatment in EGFR-mutated NSCLC: a meta-analysis. Journal of Thoracic Oncology, 13(10), S474.
[6] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-evaluations-drug-orange-book
[7] GoodRx. (n.d.). Gefitinib Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/gefitinib (Note: Pricing data is dynamic and represents consumer costs which may differ from wholesale acquisition costs.)
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