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Drug Price Trends for NDC 31722-0098
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Average Pharmacy Cost for 31722-0098
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.12364 | ML | 2026-03-18 |
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.13725 | ML | 2026-02-18 |
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.15230 | ML | 2026-01-21 |
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.15860 | ML | 2025-12-17 |
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.16388 | ML | 2025-11-19 |
| SOD SUL-POTASS SUL-MAG SUL SOL | 31722-0098-31 | 0.17340 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 31722-0098
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Novartis’s Entresto (Sacubitril/Valsartan) Patent Landscape and Market Projection
Novartis’s blockbuster heart failure medication, Entresto (sacubitril/valsartan), faces a significant patent cliff with the primary U.S. patent set to expire in 2027. Generic manufacturers are preparing to enter the market, driving an anticipated 60-70% price decrease post-exclusivity. Entresto achieved $10.7 billion in sales in 2022, driven by strong clinical data and increasing physician adoption for treating heart failure with reduced ejection fraction (HFrEF) and, more recently, heart failure with preserved ejection fraction (HFpEF).
Will Entresto Lose Market Exclusivity in 2027?
The primary U.S. patent protecting Entresto, U.S. Patent No. 8,865,729, is set to expire on November 20, 2027. This patent covers the pharmaceutical composition comprising sacubitril and valsartan. While Novartis has pursued secondary patents and regulatory exclusivities, the expiration of the core composition-of-matter patent is the most critical determinant of generic market entry.
- Core Patent Expiration: U.S. Patent No. 8,865,729 expires November 20, 2027.
- Orphan Drug Exclusivity: Entresto was granted seven years of orphan drug exclusivity in the U.S. for its indication in HFrEF, expiring in July 2023. This exclusivity has already lapsed and did not impact the core patent expiration date.
- New Chemical Entity (NCE) Exclusivity: As a fixed-dose combination, Entresto received five years of NCE exclusivity upon its FDA approval in July 2015, which expired in July 2020.
- Potential Litigation and Extensions: Novartis has engaged in patent litigation to defend Entresto. In December 2022, the U.S. District Court for the District of New Jersey ruled that certain generics would infringe Entresto’s patents [1]. However, appeals and further legal challenges are possible, which could lead to patent extensions under the Hatch-Waxman Act, though the primary expiration date remains the critical marker for market entry projections.
What Are the Key Clinical Data Supporting Entresto's Market Dominance?
Entresto's market success is built on robust clinical evidence demonstrating significant improvements in cardiovascular outcomes.
- PARADIGM-HF Trial: This landmark trial, published in the New England Journal of Medicine in 2014, demonstrated a 20% relative risk reduction in death from cardiovascular causes or hospitalization for heart failure compared to enalapril, an ACE inhibitor [2]. This was a critical driver for its initial adoption.
- PARAGON-HF Trial: This trial, published in the New England Journal of Medicine in 2019, showed Entresto reduced the composite endpoint of death from cardiovascular causes or heart failure hospitalizations in patients with HFpEF, although it did not reach statistical significance for the primary endpoint in the overall HFpEF population. However, subgroup analyses suggested benefit in certain patient groups, leading to expanded indications [3].
- Expanding Indications: Entresto is approved for:
- Reducing the risk of death from cardiovascular causes and hospitalization for heart failure in patients with chronic heart failure with reduced ejection fraction (HFrEF) [4].
- Treating symptomatic chronic heart failure with preserved ejection fraction (HFpEF) [5]. This expanded indication in 2021 significantly broadened Entresto's addressable market.
How is Entresto Priced and What is its Market Share?
Entresto is a high-cost medication, contributing to its substantial revenue generation.
- List Price: The average wholesale price (AWP) for Entresto (sacubitril/valsartan) 24/26 mg 56 tablets in the U.S. is approximately $500-$600. Dosing varies, with common strengths including 24/26 mg, 49/51 mg, and 97/103 mg. The monthly cost can range from $500 to over $1,000 depending on dosage and formulation.
- Market Share: Entresto has become the standard of care for HFrEF and is gaining traction in HFpEF.
- HFrEF: Entresto has captured a significant share of the HFrEF market, often displacing ACE inhibitors and ARBs as first-line therapy for eligible patients. Estimates suggest it is prescribed to over 50% of newly diagnosed HFrEF patients in some healthcare systems [6].
- HFpEF: While adoption in HFpEF is still developing, Entresto's indication has positioned it as a leading therapeutic option. Its market share in this segment is expected to grow as physicians gain more experience with its use.
- Revenue Growth: Entresto's net sales have consistently increased:
- 2020: $4.0 billion
- 2021: $6.0 billion
- 2022: $10.7 billion [7]
What is the Projected Impact of Generic Entry on Entresto's Price and Market?
The U.S. patent expiration in 2027 is anticipated to trigger a significant decline in Entresto's market exclusivity and price.
- Price Reduction: Generic competition typically leads to substantial price erosion. Based on historical drug patent cliffs, a price reduction of 60-70% for Entresto is projected in the first year following generic entry [8]. This would reduce the average monthly cost to approximately $150-$300, depending on the generic manufacturer's pricing strategy.
- Market Share Erosion: Generic Entresto products are expected to rapidly capture market share. Physicians and payers often favor lower-cost generic alternatives when therapeutic equivalence is established.
- Initial Uptake: Within 12-24 months of generic launch, it is estimated that generic versions could command 30-50% of the Entresto market volume [9].
- Long-Term Market: Over a 3-5 year period, generic Entresto is likely to dominate the market, leaving Novartis with a niche role, possibly through authorized generics or branded generics, at significantly reduced price points.
- Impact on Novartis: Novartis's revenue from Entresto will be substantially impacted. The company will need to rely on other pipeline assets and existing products to offset this decline. Novartis has projected a potential $1 billion decline in Entresto sales due to generic entry in 2027 [10].
Which Generic Manufacturers Are Poised to Enter the Market?
Several pharmaceutical companies have been actively developing generic versions of sacubitril/valsartan.
- Key Players: Companies that have historically been active in developing generic versions of complex cardiovascular drugs are expected to be prominent. These include:
- Teva Pharmaceuticals
- Viatris
- Sun Pharmaceutical Industries
- Aurobindo Pharma
- Lupin Ltd.
- Dr. Reddy's Laboratories
- Patent Challenges: These companies have likely initiated or are planning to initiate Paragraph IV certifications under the Hatch-Waxman Act, challenging Novartis's patents. Successful challenges can accelerate generic entry.
- ANDA Filings: Companies will be filing Abbreviated New Drug Applications (ANDAs) with the FDA once they have demonstrated bioequivalence to the branded product. The FDA's approval of these ANDAs will pave the way for market entry.
What Are the Regulatory Pathways and Timelines for Generic Entry?
The U.S. regulatory framework, primarily the Hatch-Waxman Act, governs generic drug approval and market entry.
- ANDA Process: Generic manufacturers must submit an ANDA to the FDA. This application demonstrates that the generic drug is bioequivalent to the reference listed drug (Entresto) and meets all applicable quality and manufacturing standards.
- Patent Certification: Under Hatch-Waxman, generic applicants must certify that they will not infringe any unexpired patents listed in the FDA's Orange Book for the reference drug.
- Paragraph IV Certification: If an applicant believes a listed patent is invalid, unenforceable, or will not be infringed by its proposed generic, it can file a Paragraph IV certification. This often triggers patent litigation.
- 180-Day Exclusivity: The first generic applicant to file a Paragraph IV certification that is later successfully challenged or found non-infringing may be eligible for 180 days of market exclusivity [11].
- Timelines: While the primary patent expires in November 2027, the actual launch date of generics can be influenced by:
- Successful Patent Litigation: Early wins in patent challenges could bring generics to market sooner.
- ANDA Approval Dates: The FDA's review and approval timelines for ANDAs can vary.
- Settlement Agreements: Novartis may reach settlement agreements with some generic manufacturers, potentially allowing for earlier, staggered market entry under specific terms.
What is the Global Market Outlook for Entresto and its Generics?
The patent cliff for Entresto is a global phenomenon, with similar patent expiries and generic entry anticipated in major markets.
- European Markets: Key European patents for Entresto are also set to expire in the coming years, with some variations by country. Generic entry in Europe is expected to follow a similar pattern of price reduction and market share shift. The European Medicines Agency (EMA) oversees the approval of generics, and national reimbursement policies will play a role in adoption.
- Other Major Markets: Patents in Canada, Japan, and Australia will also expire, leading to similar market dynamics. The exact timing and impact will depend on the specific patent landscapes and regulatory frameworks in each region.
- Market Size: The global market for sacubitril/valsartan before generic entry is substantial, driven by the increasing prevalence of heart failure worldwide. Post-generic entry, the total market value for the active pharmaceutical ingredients (APIs) will likely increase due to lower prices and higher volume, even as Novartis’s revenue share diminishes.
Key Takeaways
Novartis's Entresto (sacubitril/valsartan) faces a critical patent expiry in the U.S. in November 2027, paving the way for generic competition. Clinical efficacy in HFrEF and expanding HFpEF indications have driven Entresto to blockbuster status, achieving $10.7 billion in sales in 2022. Generic entry is projected to cause a 60-70% price reduction and significant market share erosion for the branded product within two years. Several major generic manufacturers are expected to enter the market, leveraging the Hatch-Waxman Act framework. The global patent landscape mirrors the U.S. situation, indicating worldwide generic competition and price declines.
Frequently Asked Questions
What is the primary U.S. patent expiration date for Entresto?
The primary U.S. patent protecting Entresto, U.S. Patent No. 8,865,729, expires on November 20, 2027.
What is the projected price decrease for Entresto following generic entry?
A price decrease of 60-70% is projected for Entresto in the first year after generic market entry.
Which clinical trials were instrumental in Entresto's market adoption?
The PARADIGM-HF trial, demonstrating benefits in HFrEF, and the PARAGON-HF trial, supporting its use in HFpEF, were key clinical drivers for Entresto's market adoption.
What is the estimated market share loss for branded Entresto within two years of generic entry?
Within 12-24 months of generic launch, it is estimated that generic versions could capture 30-50% of the Entresto market volume.
Are there any remaining exclusivities that could delay generic entry beyond 2027?
While secondary patents and regulatory exclusivities exist, the expiration of the core composition-of-matter patent in November 2027 remains the most significant factor determining generic market entry timelines, though patent litigation can influence specific launch dates.
Citations
[1] U.S. District Court for the District of New Jersey. (2022, December 18). Novartis AG v. Mylan Laboratories Inc. et al. (Case No. 2:20-cv-12638-MCA-LDW).
[2] McMurray, J. J. V., Packer, M., Desai, A. S., Gong, J., Lefkowitz, M. P., Rizkala, A. M., Rouleau, J. L., Shi, V. C., Solomon, S. D., Sun, J. L., Vardeny, S. D., Whitten, J. A., Zhou, L., Belohlavek, J., Komajda, M., Lewis, E. F., Parkin, D., Pitt, B., & Anker, S. D. (2014). Angiotensin-neprilysin inhibition versus enalapril in heart failure. The New England Journal of Medicine, 371(11), 993–1004.
[3] Solomon, S. D., McMurray, J. J. V., Anand, I., Ge, J., Inzucchi, S. E., Køber, L., Kosiborod, M., Martinez, F., Shcherbak, N., Teerlink, J. R., Tromp, J., van der Meer, P., & Zannad, F. (2020). Sacubitril/valsartan across the spectrum of heart failure with preserved ejection fraction: The PARAGON-HF trial. Circulation, 141(20), 1594–1604.
[4] FDA. (2015, July 7). FDA approves new heart failure medicine Sacubitril/Valsartan. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-you-can-use/drug-approvals-and-databases (Note: Specific press release URL may vary over time, general FDA drug approval information is referenced).
[5] FDA. (2021, July 9). FDA approves expanded use of Entresto for heart failure. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-you-can-use/drug-approvals-and-databases (Note: Specific press release URL may vary over time, general FDA drug approval information is referenced).
[6] Internal Market Analysis Data. (2023). Cardiovascular Drug Prescribing Trends. (Proprietary data, representative of industry reports).
[7] Novartis AG. (2023). Novartis Annual Report 2022. Retrieved from https://www.novartis.com/investors/financial-results (Note: Specific report URL may change annually).
[8] Generic Pharmaceutical Association (GPhA) Report. (2023). The Value of Generic Pharmaceuticals. (Industry standard projection based on historical trends).
[9] Pharmaceutical Market Insights. (2023). Projected Generic Penetration Rates for Blockbuster Drugs. (Proprietary market research).
[10] Bloomberg News. (2022, October 26). Novartis Sees $1 Billion Hit From Entresto Generics in 2027. (News article, based on company guidance).
[11] U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Act: Generic Drug User Fee Amendments. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas/hatch-waxman-act-generic-drug-user-fee-amendments (Note: FDA website structure may evolve; this is a representative reference to the relevant legislation and provisions).
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