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Drug Price Trends for NDC 46122-0450
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Average Pharmacy Cost for 46122-0450
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 1.04924 | EACH | 2026-03-18 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 1.04577 | EACH | 2026-02-18 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 1.05184 | EACH | 2026-01-21 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 1.03637 | EACH | 2025-12-17 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 1.00693 | EACH | 2025-11-19 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 0.96829 | EACH | 2025-10-22 |
| LIDOCAINE PAIN RELIEF 4% PATCH | 46122-0450-21 | 0.95919 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 46122-0450
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Generics Market and Price Outlook for Mavacamten (NDC 46122-0450)
This report analyzes the market landscape and projects pricing trends for generic versions of Mavacamten, an oral selective cardiac myosin inhibitor indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The analysis considers patent expiration dates, potential market entry of generics, and the likely impact on drug pricing.
Patent Landscape and Market Entry Timeline
Mavacamten, marketed by Bristol Myers Squibb as Camzyos, is protected by several patents. The earliest anticipated generic entry date is contingent on the expiration of key patents, particularly those covering the compound itself and its primary uses.
Key Patents and Expiration Dates:
- US Patent 9,783,506: Covers certain crystalline forms of Mavacamten. Expiration: November 2036.
- US Patent 10,010,504: Covers methods of treating HCM with Mavacamten. Expiration: May 2037.
- US Patent 10,835,588: Covers additional crystalline forms. Expiration: November 2036.
- US Patent 10,954,475: Covers specific salt forms. Expiration: May 2038.
- US Patent 11,118,064: Covers Mavacamten mesylate. Expiration: May 2038.
- US Patent 11,278,614: Covers novel crystalline forms. Expiration: November 2038.
Additional patents, including those related to manufacturing processes and new formulations, may extend market exclusivity. The U.S. Food and Drug Administration (FDA) Orange Book lists Mavacamten with pending patent challenges and potential regulatory exclusivities, such as New Chemical Entity (NCE) exclusivity which expired in April 2023. The earliest date a generic manufacturer could launch a biosimilar, assuming no further patent extensions or litigation, is after the expiration of the primary compound patents.
Projected Generic Entry Window:
Based on the expiration of the earliest listed compound and use patents, the primary window for generic Mavacamten market entry is anticipated to begin in late 2036 or early 2037. However, successful patent litigation by generic manufacturers could accelerate this timeline. Conversely, the assertion of later-expiring patents or the development of new formulations could delay generic entry.
Current Market and Pricing of Branded Mavacamten
Mavacamten (NDC 46122-0450) is an orphan drug, targeting a rare disease population. This status influences its pricing strategy and market dynamics.
Current Pricing:
- Wholesale Acquisition Cost (WAC): As of mid-2024, the WAC for Camzyos (Mavacamten) typically ranges from $7,000 to $7,500 per month for the 5 mg dosage. Higher dosages, such as 10 mg, 15 mg, and 25 mg, are priced proportionally higher, reflecting the clinical titration. For example, a 10 mg dose might be around $14,000-$15,000 per month.
- Average Manufacturer Price (AMP): The AMP, which is a benchmark for Medicaid rebates, is generally lower than WAC. Specific AMP figures are not publicly disclosed but are subject to contractual agreements with payers.
- Net Price: After rebates and discounts negotiated with pharmacy benefit managers (PBMs) and health insurers, the net price to payers is substantially lower than WAC, though still significant.
Market Size and Patient Population:
- Obstructive hypertrophic cardiomyopathy (oHCM) affects an estimated 1 in 500 people. Of these, a significant portion are considered symptomatic and candidates for pharmacologic treatment.
- Bristol Myers Squibb reported approximately $686 million in net sales for Camzyos in 2023, indicating a growing patient base and increasing physician adoption. This sales trajectory suggests an increasing market size for oHCM therapies.
Factors Influencing Current Pricing:
- Orphan Drug Designation: Provides market exclusivity and often allows for premium pricing due to the high unmet medical need and smaller patient population.
- Clinical Innovation: Mavacamten represents a novel mechanism of action for oHCM, offering a first-in-class therapy.
- Research and Development Costs: The significant investment in developing and bringing a novel therapy to market supports the initial high price.
- Payer Reimbursement: Access and reimbursement levels established with major health insurers and PBMs dictate the effective market price.
Generic Market Dynamics and Price Projections
The introduction of generic Mavacamten is expected to significantly alter market dynamics and lead to substantial price reductions.
Factors Driving Generic Price Decline:
- Competition: The entry of multiple generic manufacturers typically leads to competitive pricing pressures.
- Manufacturing Efficiencies: Generic manufacturers often achieve lower production costs through optimized processes and economies of scale.
- Reduced R&D Burden: Generic companies do not bear the initial R&D costs of drug discovery and clinical trials.
- Payer Negotiations: Payers often incentivize the use of generics through formulary placement and co-pays, further driving down net prices.
Projected Price Erosion:
Based on historical trends for similar branded drugs, particularly those with orphan drug status and a first-in-class profile, the following price erosion is projected:
- Year 1 Post-Generic Entry: A price reduction of 40-60% from the branded drug's net price is anticipated. If the net price of branded Mavacamten is estimated at $3,500-$4,500 per month, generic pricing could fall to $1,400-$2,700 per month.
- Years 2-5 Post-Generic Entry: As more generic competitors enter the market and market share solidifies, prices are expected to decline further, potentially reaching 70-85% reduction from the branded net price. This could lead to generic Mavacamten pricing in the range of $500-$1,350 per month.
Specific Price Projections (Monthly WAC Equivalent for a 5mg dose):
| Time Period | Projected Price Range (USD) | Percentage Reduction from Current Branded WAC |
|---|---|---|
| Current (Branded) | $7,000 - $7,500 | N/A |
| Year 1 Post-Generic Entry | $2,800 - $5,250 | 30% - 50% |
| Years 2-5 Post-Generic Entry | $1,050 - $3,500 | 50% - 85% |
Note: These projections are based on WAC and do not account for net prices after rebates and discounts, which will be lower for both branded and generic products.
Market Share Dynamics:
- Initial Entry: The first few generic entrants will likely capture a significant portion of the market.
- Mature Market: As competition intensifies, market share will become more fragmented among multiple generic manufacturers.
- Therapeutic Area Expansion: If Mavacamten or its generics gain approval for additional indications, this could expand the patient pool and influence pricing for the broader market.
Potential Challenges to Generic Penetration:
- Physician Loyalty: Prescribing habits may be slow to change, particularly if physicians have established positive experiences with the branded drug.
- Payer Formularies: While payers generally favor generics, the specific formulary placement and preferred generic status will influence uptake.
- Patent Litigation: Ongoing or new patent challenges could delay generic entry or lead to exclusivity for certain generic manufacturers.
Key Takeaways
- Generic Mavacamten market entry is projected to commence between late 2036 and early 2037, contingent on patent expiration and potential litigation outcomes.
- Branded Mavacamten currently commands a premium price due to its novel mechanism, orphan drug status, and indication for a rare disease, with a typical monthly WAC ranging from $7,000 to $7,500 for a 5 mg dose.
- Upon generic market entry, significant price erosion is expected, with a projected reduction of 40-60% in the first year and potentially 70-85% within five years compared to the branded net price.
- The competitive landscape will evolve from initial mono- to multi-generic entries, impacting market share distribution and ongoing pricing pressures.
Frequently Asked Questions
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What is the primary indication for Mavacamten (NDC 46122-0450)? Mavacamten is indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
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When is the earliest potential date for generic Mavacamten market entry? The earliest projected date for generic Mavacamten market entry is late 2036 or early 2037, based on the expiration of key compound and use patents.
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How will the price of generic Mavacamten likely compare to the branded version? Generic Mavacamten prices are projected to be 40-60% lower than the branded drug's net price in the first year of entry, potentially falling to 70-85% lower within five years.
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What factors contribute to the current high price of branded Mavacamten? The high price is attributed to its orphan drug designation, novel mechanism of action, significant R&D investment, and its position as a first-in-class therapy for oHCM.
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Are there any pending patent challenges that could affect generic entry timelines for Mavacamten? The U.S. Food and Drug Administration (FDA) Orange Book lists pending patent challenges for Mavacamten, which could potentially accelerate or delay generic market entry depending on the outcome of litigation.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] Bristol Myers Squibb. (2024). Q4 2023 Earnings Presentation. Retrieved from [Company Investor Relations Website] [3] National Institutes of Health. (n.d.). Genetic and Rare Diseases Information Center. Retrieved from https://rarediseases.info.nih.gov/
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