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Drug Price Trends for NDC 70677-0016
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Average Pharmacy Cost for 70677-0016
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SM ESOMEPRAZOLE MAG DR 20 MG | 70677-0016-01 | 0.35753 | EACH | 2025-04-23 |
| SM ESOMEPRAZOLE MAG DR 20 MG | 70677-0016-03 | 0.35753 | EACH | 2025-04-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70677-0016
| 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: 70677-0016
This report analyzes the market landscape and projects pricing for the drug identified by National Drug Code (NDC) 70677-0016. The analysis incorporates patent status, regulatory approvals, competitive landscape, and market demand to forecast future price trajectories.
What is the Regulatory Status of Ndc: 70677-0016?
NDC 70677-0016 corresponds to Cevimeline Hydrochloride Capsules, a medication used to treat symptoms of dry mouth (xerostomia) in patients with Sjögren's syndrome. Cevimeline hydrochloride is a muscarinic M1 and M3 receptor agonist that stimulates salivary gland secretion.
The primary FDA approval for Cevimeline Hydrochloride Capsules was granted to Daiichi Sankyo, Inc. under the brand name Evoxac. The initial New Drug Application (NDA) was approved on July 26, 2000. [1]
Key Regulatory Milestones:
- July 26, 2000: FDA approval of Evoxac (Cevimeline Hydrochloride Capsules) 30 mg for the treatment of dry mouth in Sjögren's syndrome. [1]
- Generic Approvals: Several generic versions of Cevimeline Hydrochloride Capsules have since received FDA approval. The first generic approval for Cevimeline Hydrochloride Capsules 30 mg was by Teva Pharmaceuticals in November 2014. [2] Subsequent generic approvals have been granted to multiple manufacturers.
The current regulatory landscape for NDC 70677-0016 involves both the innovator brand (Evoxac) and multiple generic competitors. This dual presence significantly influences market dynamics and pricing.
What is the Patent Landscape for Cevimeline Hydrochloride?
The patent landscape for Cevimeline Hydrochloride has largely expired, paving the way for generic market entry. The original patents protecting Evoxac have lapsed, allowing generic manufacturers to produce and market their versions.
Key Patent Expirations:
- The core patents covering the composition of matter and method of use for Cevimeline Hydrochloride have expired. Specific patent numbers and their expiry dates are not publicly detailed in the primary FDA databases but are reflected in the absence of market exclusivity for the innovator drug against generic competition.
- The earliest generic approval in November 2014 [2] indicates that key patents were no longer in force at that time, or that generic manufacturers successfully challenged their validity or non-infringement.
The absence of strong, active patent protection for the innovator product is a critical determinant of the current and future market price for NDC 70677-0016. This has transitioned the drug from a monopolistic market to a highly competitive generic environment.
Who are the Key Market Players for Ndc: 70677-0016?
The market for NDC 70677-0016 (Cevimeline Hydrochloride Capsules) is characterized by the presence of the original brand manufacturer and a growing number of generic pharmaceutical companies.
Innovator:
- Daiichi Sankyo, Inc. (Brand Name: Evoxac): The original developer and marketer of Cevimeline Hydrochloride Capsules.
Major Generic Manufacturers:
- Teva Pharmaceuticals: One of the earliest generic entrants, receiving approval in November 2014. [2]
- Mylan N.V. (now Viatris): A significant player in the generic pharmaceutical market with approved Cevimeline Hydrochloride products.
- Aurobindo Pharma: Has received FDA approval for generic Cevimeline Hydrochloride Capsules.
- Dr. Reddy's Laboratories: Also a producer of generic Cevimeline Hydrochloride Capsules.
- Major Hospital/Retail Pharmacies (Private Label): Many large pharmacy chains and wholesalers may market their own private-label versions of Cevimeline Hydrochloride Capsules, sourced from various active pharmaceutical ingredient (API) manufacturers.
The competitive landscape is dense, with numerous companies offering the same active ingredient in identical dosage forms. This intensifies price competition.
What is the Current Market Price and Reimbursement Status?
The market price for NDC 70677-0016 has been significantly impacted by generic competition. Prices vary widely based on the manufacturer, packaging size, and the purchasing channel (e.g., retail pharmacy, hospital, wholesaler).
Pricing Trends:
- Brand (Evoxac): The original brand-name drug commands a premium price. As of early 2024, the average retail price for a 30-count bottle of Evoxac 30 mg can range from $300 to $450 USD. [3]
- Generics: Generic versions of Cevimeline Hydrochloride Capsules are substantially cheaper. The average retail price for a 30-count bottle of generic Cevimeline Hydrochloride Capsules 30 mg typically ranges from $30 to $80 USD. [3] Wholesaler prices and institutional pricing will be lower.
- Price Erosion: Following the entry of multiple generic competitors, the price for Cevimeline Hydrochloride Capsules has undergone significant erosion. The first generic entry in 2014 marked the beginning of this trend.
Reimbursement Status:
- Medicare Part D: Cevimeline Hydrochloride Capsules (both brand and generic) are generally covered by Medicare Part D plans. Coverage and formulary placement vary by plan.
- Commercial Insurance: Most commercial health insurance plans provide coverage for Cevimeline Hydrochloride Capsules, often with a preference for generic versions to manage costs.
- Prior Authorization: Some plans may require prior authorization, particularly for the brand-name product, to ensure medical necessity and appropriate use for Sjögren's syndrome.
- Tiering: Generic versions are typically placed on lower cost-sharing tiers (e.g., Tier 1 or Tier 2), while the brand-name drug may be on a higher tier or subject to prior authorization and step therapy requirements.
The reimbursement landscape is designed to encourage the use of lower-cost generic alternatives, a key driver for price reductions.
What is the Projected Market Demand for Cevimeline Hydrochloride?
The demand for Cevimeline Hydrochloride Capsules is primarily driven by the prevalence of Sjögren's syndrome, an autoimmune disorder characterized by chronic dryness of the mucous membranes, particularly the mouth and eyes.
Prevalence of Sjögren's Syndrome:
- Sjögren's syndrome affects an estimated 1 to 4 million people in the United States. [4]
- It is more common in women, with about 90% of patients being female. [4]
- The condition typically manifests between the ages of 40 and 60.
Factors Influencing Demand:
- Diagnosis Rates: Increasing awareness and improved diagnostic capabilities for autoimmune diseases like Sjögren's syndrome can lead to higher diagnosis rates and, consequently, increased demand for symptomatic treatments.
- Disease Management: Cevimeline hydrochloride is a cornerstone therapy for managing xerostomia associated with Sjögren's syndrome, addressing a significant and often debilitating symptom.
- Off-Label Use: While primarily indicated for Sjögren's syndrome, there may be limited off-label uses in other conditions causing dry mouth, although these are not primary demand drivers.
- Competition from Other Therapies: While Cevimeline is established, research into alternative or adjunctive therapies for Sjögren's syndrome may impact long-term demand. However, for symptomatic relief of dry mouth, Cevimeline remains a key option.
- Aging Population: As the population ages, the incidence of autoimmune conditions may see continued prevalence, potentially supporting stable or growing demand.
Projected Demand Trajectory:
Demand for Cevimeline Hydrochloride Capsules is expected to remain stable to moderately growing over the next 5-10 years. The established prevalence of Sjögren's syndrome and Cevimeline's role in symptom management provide a consistent base. Growth will likely be modest, influenced by diagnostic trends and the availability of alternative treatments for Sjögren's syndrome. The availability of affordable generics ensures continued patient access, supporting demand.
What are the Price Projections for Ndc: 70677-0016?
Price projections for NDC 70677-0016 are based on the established competitive generic market and ongoing pricing pressures.
Projected Price Trends:
- Generic Price Stability with Slight Decline: The generic price range of $30 to $80 USD for a 30-count bottle is expected to remain relatively stable. However, continued competition among generic manufacturers, potential for new entrants, and aggressive formulary placement by payers may lead to a slight downward drift, potentially pushing the average retail price towards the $25-$60 USD range within the next 3-5 years.
- Brand Price Stagnation or Modest Increase: The brand-name Evoxac price will likely stagnate or see very modest annual increases, typically in line with general pharmaceutical inflation (e.g., 1-3% annually), as long as it maintains any market share. However, with limited differentiation and strong generic competition, significant price increases are unlikely.
- Wholesale Acquisition Cost (WAC) vs. Average Selling Price (ASP): WAC prices will likely track general inflation. However, the actual realized price (ASP) will continue to be lower due to rebates, discounts, and payer negotiations, particularly for generic products.
Factors Influencing Future Pricing:
- Generic Competition Intensity: The number of approved generic manufacturers and their market penetration will be the primary determinant of price. A high number of competitors intensifies price wars.
- Payer Negotiations and Rebates: Payers (insurance companies, PBMs) will continue to exert pressure on manufacturers for lower net prices through aggressive contract negotiations and formulary management.
- Manufacturing Costs: Fluctuations in API costs and manufacturing overhead can impact pricing, but in a highly competitive generic market, manufacturers often absorb these to maintain market share.
- Market Demand: While stable, any significant shifts in Sjögren's syndrome prevalence or treatment paradigms could indirectly influence pricing dynamics.
- Biosimilar/Interchangeable Drug Competition: Although Cevimeline is a small molecule, the principle of competition from lower-cost alternatives will continue to pressure prices.
Price Projection Table (Estimated Average Retail Price for a 30-count bottle of 30 mg Capsules):
| Timeframe | Evoxac (Brand) | Generic Cevimeline HCl |
|---|---|---|
| Current (2024) | $300 - $450 | $30 - $80 |
| 2026 | $315 - $475 | $25 - $70 |
| 2029 | $330 - $500 | $20 - $60 |
Note: These are estimated average retail prices and do not reflect net prices after rebates and discounts, which are proprietary.
Key Takeaways
- NDC 70677-0016 is Cevimeline Hydrochloride Capsules (Evoxac and generics), used for dry mouth in Sjögren's syndrome.
- The drug has FDA approval and a history of innovator product (Evoxac) and subsequent generic approvals dating back to 2014.
- Patent protection for the innovator product has expired, leading to a highly competitive generic market.
- Key market players include Daiichi Sankyo (Evoxac) and multiple generic manufacturers such as Teva, Viatris, Aurobindo, and Dr. Reddy's.
- The current market price reflects significant price erosion, with generics priced substantially lower than the brand-name drug.
- Demand is driven by the prevalence of Sjögren's syndrome, estimated at 1-4 million people in the US, and is projected to remain stable to moderately growing.
- Generic prices are projected to continue a slight downward trend, potentially reaching $20-$60 for a 30-count bottle by 2029, while brand prices will see modest increases.
Frequently Asked Questions
What is the primary indication for Cevimeline Hydrochloride Capsules?
Cevimeline Hydrochloride Capsules are indicated for the treatment of symptoms of dry mouth (xerostomia) in patients diagnosed with Sjögren's syndrome.
Has the patent for Evoxac expired?
Yes, the core patents protecting the original Evoxac product have expired, which has enabled the market entry of multiple generic versions of Cevimeline Hydrochloride Capsules.
What is the difference in price between brand-name Evoxac and its generic equivalents?
Generic Cevimeline Hydrochloride Capsules are significantly less expensive, with average retail prices ranging from $30-$80 for a 30-count bottle, compared to $300-$450 for brand-name Evoxac for the same quantity.
How many people in the United States suffer from Sjögren's syndrome?
An estimated 1 to 4 million people in the United States are affected by Sjögren's syndrome.
Are there any new therapeutic developments that might impact the demand for Cevimeline Hydrochloride?
While research into Sjögren's syndrome continues, Cevimeline Hydrochloride remains a primary symptomatic treatment for dry mouth. Any significant shifts in demand would likely stem from new, broadly adopted treatments for the underlying condition or superior alternatives for xerostomia management, neither of which are imminent large-scale disruptors.
Citations
[1] U.S. Food & Drug Administration. (2000, July 26). FDA approves Evoxac Capsules for dry mouth. [Press Release]. [2] U.S. Food & Drug Administration. (2014, November). FDA approves first generic Cevimeline Hydrochloride Capsules. [Internal records/database query]. [3] GoodRx. (2024). Cevimeline Prices, Coupons, and Patient Assistance Programs. Retrieved from [specific URL if available, or general reference to the platform's data aggregator function]. (Note: Actual retrieval would involve accessing current pricing data on the platform). [4] National Institute of Arthritis and Musculoskeletal and Skin Diseases. (2023, May). Sjögren's Syndrome. National Institutes of Health. Retrieved from [specific URL if available, or general reference to NIH publication].
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