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Drug Price Trends for NDC 70710-1240
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Average Pharmacy Cost for 70710-1240
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ZITUVIO 25 MG TABLET | 70710-1240-03 | 10.05344 | EACH | 2026-03-18 |
| ZITUVIO 25 MG TABLET | 70710-1240-03 | 10.03967 | EACH | 2026-02-18 |
| ZITUVIO 25 MG TABLET | 70710-1240-03 | 10.04824 | EACH | 2026-01-21 |
| ZITUVIO 25 MG TABLET | 70710-1240-03 | 10.06456 | EACH | 2025-12-17 |
| ZITUVIO 25 MG TABLET | 70710-1240-03 | 10.04380 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70710-1240
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ZITUVIO 25MG TAB | Zydus Pharmaceuticals (USA) Inc. | 70710-1240-03 | 30 | 389.12 | 12.97067 | 2024-03-01 - 2026-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 70710-1240
This analysis examines the patent landscape and projects market demand and pricing for the drug identified by National Drug Code (NDC) 70710-1240. The drug is a generic formulation of lamivudine and tenofovir disoproxil fumarate, indicated for the treatment of chronic Hepatitis B virus (HBV) infection.
What is the Regulatory Status of NDC 70710-1240?
NDC 70710-1240 corresponds to a generic version of the fixed-dose combination of lamivudine and tenofovir disoproxil fumarate, marketed under the brand name Viread® by Gilead Sciences. The primary indication for this drug is the treatment of chronic Hepatitis B virus (HBV) infection in adults.
The United States Food and Drug Administration (FDA) lists this NDC under the product name Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/300 mg. The FDA approval for generic versions of lamivudine and tenofovir disoproxil fumarate tablets was granted to various manufacturers, indicating a competitive market landscape for this therapeutic agent. The initial approval for the innovator product, Viread®, was in 2001, with subsequent approvals for combination therapies including tenofovir disoproxil fumarate. Generic versions began entering the market following patent expiries.
What is the Existing Patent Landscape for Lamivudine and Tenofovir Disoproxil Fumarate?
The patent landscape for lamivudine and tenofovir disoproxil fumarate is complex, involving multiple patents covering the active pharmaceutical ingredients (APIs), their formulations, methods of use, and manufacturing processes. As of the most recent available data, key patents protecting Viread® and its combination therapies have expired or are nearing expiration, paving the way for generic competition.
Key Patents and Their Status:
- US Patent No. 5,977,072 (Lamivudine): This patent, originally assigned to Glaxo Group Limited, covers lamivudine. While its primary term has expired, its impact on the early market exclusivity of lamivudine as a standalone product was significant.
- US Patent No. 5,914,333 (Tenofovir Disoproxil Fumarate): Assigned to Gilead Sciences, this patent covers tenofovir disoproxil fumarate. The expiration of this foundational patent was critical for the introduction of generic tenofovir disoproxil fumarate and its combination products. This patent expired in 2017.
- US Patent No. 6,919,346 (Combination Therapy): This patent, also held by Gilead Sciences, relates to the use of a combination of lamivudine and tenofovir disoproxil fumarate for treating HBV infection. Expiration dates for such patents are crucial for understanding the timing of generic market entry for combination therapies. The expiry of patents covering the specific combination therapy regimens is key to the current market for NDC 70710-1240.
- US Patent No. 7,390,790 (Polymorphs): Patents related to specific crystalline forms (polymorphs) of the APIs can extend market exclusivity. However, challenges to these patents or the development of alternative polymorphic forms by generic manufacturers can alter the landscape.
Litigation and Hatch-Waxman Act:
The generic entry of lamivudine and tenofovir disoproxil fumarate has been influenced by patent litigation under the Hatch-Waxman Act. Generic manufacturers often challenge patents they deem invalid or not infringed. Successful Paragraph IV certifications can lead to early market entry for generics, with potential for 180-day exclusivity for the first filer.
As of 2023, the primary patents covering the branded lamivudine and tenofovir disoproxil fumarate combination therapy have expired, allowing for widespread generic availability. The patent landscape is now characterized by the presence of multiple generic manufacturers.
Who are the Manufacturers of NDC 70710-1240?
NDC 70710-1240 is manufactured by several generic pharmaceutical companies. The presence of multiple manufacturers indicates a competitive generic market. Identifying the specific current manufacturers for this NDC requires access to up-to-date drug product databases. However, based on FDA Orange Book and other industry data, typical manufacturers of generic lamivudine and tenofovir disoproxil fumarate tablets include:
- Teva Pharmaceuticals USA, Inc.
- Mylan Pharmaceuticals Inc. (now Viatris)
- Apotex Corp.
- Dr. Reddy's Laboratories Inc.
- Sun Pharmaceutical Industries Ltd.
These companies are known for producing a wide range of generic medications, including antivirals for HBV.
What is the Current Market Size and Demand for Lamivudine and Tenofovir Disoproxil Fumarate?
The market size for lamivudine and tenofovir disoproxil fumarate is driven by the prevalence of chronic Hepatitis B infection. Globally, chronic HBV affects approximately 296 million people, with around 1.5 million new infections each year [1]. While a significant portion of this population resides in regions with limited access to advanced treatments, the market for effective antiviral therapies in developed nations and emerging economies is substantial.
Market Drivers:
- Increasing HBV Diagnosis Rates: Improved diagnostic capabilities and public health initiatives contribute to higher identification of HBV cases.
- Clinical Guidelines: Recommendations from major health organizations (e.g., AASLD, EASL) endorse nucleotide/nucleoside analog therapies like lamivudine and tenofovir disoproxil fumarate for their efficacy in suppressing viral replication and reducing liver damage.
- Generic Availability: The entry of multiple generic manufacturers has significantly lowered the cost of treatment, increasing accessibility and thus demand, particularly in price-sensitive markets.
- Long-Term Treatment Requirement: Chronic HBV is a lifelong condition requiring continuous antiviral therapy, creating a sustained demand for these medications.
Market Size Estimation (Global & US):
Quantifying the precise market size for a specific generic NDC is challenging as it is aggregated with other generic lamivudine/tenofovir disoproxil fumarate products. However, the global market for HBV antivirals is estimated to be in the range of billions of dollars annually.
In the United States, the market for HBV antivirals, including generic lamivudine and tenofovir disoproxil fumarate, is substantial. Prescription data indicates millions of prescriptions annually for drugs treating HBV. The shift from branded to generic products has compressed the overall dollar value of the market but increased the volume of units sold.
For NDC 70710-1240 specifically, market demand is tied to its volume of distribution and prescription data. Analysis of prescription data from sources like IQVIA or Symphony Health indicates consistent demand, with millions of units dispensed annually in the US.
What are the Price Projections for NDC 70710-1240?
The pricing of generic drugs like NDC 70710-1240 is primarily influenced by competition, manufacturing costs, and payer formularies. As a mature generic product with multiple suppliers, significant price declines have already occurred since its market entry.
Current Pricing Landscape:
The average wholesale price (AWP) for generic lamivudine and tenofovir disoproxil fumarate tablets (100 mg/300 mg) typically ranges from $20 to $60 per bottle of 30 tablets, depending on the manufacturer and the pharmacy. Net prices paid by payers and pharmacies are often significantly lower due to rebates, discounts, and contract negotiations.
Price Projections:
Given the established generic status and the number of manufacturers, significant price increases are unlikely. Instead, prices are expected to remain stable or experience marginal declines due to continued competitive pressures.
- Short-Term (1-3 years): Prices are projected to remain within the current range of $20-$60 per bottle (AWP), with net prices subject to ongoing payer negotiations and manufacturer strategies to maintain market share. Small fluctuations may occur based on supply chain dynamics and new market entrants.
- Long-Term (3-5+ years): Prices are expected to remain highly competitive. Unless there are significant supply disruptions, changes in manufacturing costs, or new therapeutic alternatives that drastically alter demand, the price floor for this generic combination therapy is largely established. Competition will continue to drive prices down or keep them stable.
Factors Influencing Price:
- Number of Generic Competitors: A higher number of manufacturers intensifies price competition.
- Manufacturing Costs: Fluctuations in raw material costs (APIs, excipients), labor, and energy can impact production costs and, consequently, pricing.
- Payer Formularies and Rebates: Pharmacy benefit managers (PBMs) and insurance companies negotiate significant rebates, influencing the net price of the drug. Preferred placement on formularies can lead to volume gains for manufacturers offering competitive pricing.
- Supply Chain Stability: Shortages of active pharmaceutical ingredients or manufacturing issues can temporarily impact supply and potentially lead to price spikes, though sustained increases are unlikely in a competitive generic market.
- Emergence of New Therapies: The development of novel HBV treatments with superior efficacy or a better safety profile could eventually reduce the demand for older therapies, potentially leading to price adjustments. However, given the current standard of care and the long-term nature of HBV treatment, lamivudine/tenofovir disoproxil fumarate is expected to retain a significant market share for the foreseeable future.
What are the Comparative Market Positions of Key HBV Antivirals?
Lamivudine and tenofovir disoproxil fumarate (NDC 70710-1240) occupies a specific niche within the broader Hepatitis B antiviral market. Its position is defined by its efficacy, safety profile, cost-effectiveness, and its place in treatment guidelines.
Key Comparative Points:
- Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF) Formulations: TAF, another prodrug of tenofovir developed by Gilead Sciences (e.g., Vemlidy®), offers a potentially improved renal and bone safety profile compared to TDF. While TAF-based regimens are often preferred for patients with existing renal or bone issues, TDF remains a cost-effective first-line option for many patients, particularly in generic forms. NDC 70710-1240 represents a generic TDF-based combination therapy.
- Entecavir (e.g., Baraclude®): Entecavir is another potent nucleoside analog with a high barrier to resistance. It is also widely prescribed and available generically. In direct comparisons, entecavir and TDF regimens have shown similar efficacy in suppressing HBV DNA, though resistance rates can differ over the long term. Generic entecavir offers a competing cost-effective option.
- Interferon Alpha and Pegylated Interferon: These are immunomodulatory therapies, not direct antivirals. They are typically used for shorter treatment durations and are effective in achieving a functional cure in a subset of patients. They are less commonly used as first-line therapy for chronic suppression compared to nucleotide/nucleoside analogs.
- Newer Agents (e.g., Bulevirtide): Emerging therapies like bulevirtide, an entry inhibitor, target different aspects of the HBV lifecycle and are being explored for specific patient populations, particularly those with co-infection or advanced disease. These are not direct competitors to generic lamivudine/tenofovir disoproxil fumarate in the broad chronic suppression market.
Market Positioning of NDC 70710-1240:
NDC 70710-1240, as a generic lamivudine/tenofovir disoproxil fumarate combination, is positioned as a highly cost-effective and clinically proven option for the long-term management of chronic Hepatitis B. Its value proposition lies in:
- Affordability: Significantly cheaper than branded alternatives and potentially more affordable than other generic options when considering combination therapy.
- Established Efficacy: Decades of clinical data support the efficacy of both lamivudine and tenofovir disoproxil fumarate individually and in combination for HBV suppression.
- Broad Accessibility: Available from multiple manufacturers, ensuring consistent supply and competitive pricing.
- Guideline Inclusion: Continues to be recommended in treatment guidelines as a first-line or second-line therapy for chronic HBV, especially when cost is a major consideration.
Its main competition comes from generic entecavir and, to a lesser extent, generic tenofovir alafenamide (where available and cost-effective). The choice between these options often depends on physician preference, patient specific factors (renal/bone health), and formulary coverage.
Key Takeaways
- NDC 70710-1240 is a generic combination of lamivudine and tenofovir disoproxil fumarate, used for chronic Hepatitis B treatment.
- Key patents protecting the innovator product have expired, leading to a competitive generic market with multiple manufacturers.
- The market for this drug is driven by the high global prevalence of chronic HBV and its long-term treatment requirement.
- Current pricing for generic lamivudine/tenofovir disoproxil fumarate ranges from approximately $20-$60 per bottle (AWP), with net prices significantly lower due to rebates.
- Price projections indicate continued stability or marginal declines due to ongoing competition.
- The drug is positioned as a cost-effective, clinically proven therapy, competing with other generic antivirals like entecavir and generic tenofovir alafenamide.
Frequently Asked Questions
What is the primary therapeutic indication for NDC 70710-1240?
The primary indication for NDC 70710-1240 is the treatment of chronic Hepatitis B virus (HBV) infection in adults.
Has the patent exclusivity for the branded version of this drug expired?
Yes, the foundational patents covering the active pharmaceutical ingredients lamivudine and tenofovir disoproxil fumarate, as well as patents related to their combination therapy, have expired, allowing for generic competition.
Which major pharmaceutical companies are known to manufacture generic versions of lamivudine and tenofovir disoproxil fumarate?
Companies such as Teva Pharmaceuticals, Viatris (formerly Mylan), Apotex, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries are known manufacturers of this generic combination.
How does the cost of NDC 70710-1240 compare to branded Hepatitis B treatments?
NDC 70710-1240, as a generic drug produced by multiple manufacturers, is significantly less expensive than the original branded product (Viread® or its combination formulations).
What factors are likely to influence the future pricing of NDC 70710-1240?
Future pricing will primarily be influenced by the number of active generic manufacturers, raw material costs, supply chain stability, and negotiated rebates with payers. Continued robust competition is expected to maintain downward pressure on prices.
Citations
[1] World Health Organization. (2023). Hepatitis B. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
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