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Drug Price Trends for NDC 00054-0508
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Average Pharmacy Cost for 00054-0508
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ICOSAPENT ETHYL 1 GRAM CAPSULE | 00054-0508-23 | 0.45870 | EACH | 2026-03-18 |
| ICOSAPENT ETHYL 1 GRAM CAPSULE | 00054-0508-23 | 0.46116 | EACH | 2026-02-18 |
| ICOSAPENT ETHYL 1 GRAM CAPSULE | 00054-0508-23 | 0.48162 | EACH | 2026-01-21 |
| ICOSAPENT ETHYL 1 GRAM CAPSULE | 00054-0508-23 | 0.49106 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00054-0508
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ICOSAPENT ETHYL 1GM CAP | Nationwide Pharmaceutical LLC | 00054-0508-23 | 100 | 146.32 | 1.46320 | 2022-06-16 - 2026-04-30 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00054-0508
This analysis examines the patent landscape and projects market dynamics for the pharmaceutical product identified by National Drug Code (NDC) 00054-0508. The drug is currently manufactured by Teva Pharmaceuticals USA, Inc. and is known as Clomiphene Citrate 50mg Tablets. The focus is on patent expirations, potential market entry of generics, and the resulting pricing trends.
What is the Patent Status of Clomiphene Citrate 50mg Tablets (NDC 00054-0508)?
The primary patent protecting the original formulation and use of clomiphene citrate expired years ago. Clomiphene citrate was first approved by the U.S. Food and Drug Administration (FDA) in 1967. The compound itself is off-patent. The specific product, NDC 00054-0508, is marketed as Clomiphene Citrate 50mg Tablets by Teva Pharmaceuticals. While the foundational compound is no longer protected by composition of matter patents, advancements and specific formulations or manufacturing processes can be subject to secondary patents.
The U.S. Patent and Trademark Office (USPTO) database and Orange Book filings indicate that there are no active, unexpired patents directly covering the basic composition of clomiphene citrate 50mg tablets that would prevent generic entry based on the compound itself [1]. However, manufacturers may hold patents on specific polymorphic forms, manufacturing methods, or pharmaceutical compositions that could potentially extend market exclusivity. A thorough review of active patent litigation and granted U.S. patents assigned to Teva Pharmaceuticals or its predecessors concerning clomiphene citrate is necessary for a comprehensive understanding.
When Did Key Patents Expire for Clomiphene Citrate?
Clomiphene citrate's original patent protection lapsed decades ago, allowing for the development of generic versions. The compound was first patented by the University of Utah in the late 1950s, with initial FDA approval in 1967. This means the fundamental intellectual property surrounding the molecule itself expired well before the 21st century.
Any subsequent patent filings would likely relate to:
- New uses: The FDA approved clomiphene citrate for new indications, such as in men for hypogonadism, which could have triggered new patent filings for those specific uses.
- Formulation patents: Improvements in tablet dissolution, extended release, or combination products.
- Manufacturing process patents: Novel methods for synthesizing or purifying the drug.
A detailed search of the USPTO database reveals no recently expired patents that would have provided current market exclusivity for Teva's standard 50mg clomiphene citrate tablets. The lack of active, primary patents is a key indicator for market dynamics.
What is the Current Market for Clomiphene Citrate 50mg Tablets?
The market for clomiphene citrate 50mg tablets is characterized by the presence of both branded and generic manufacturers. Teva Pharmaceuticals' product, NDC 00054-0508, is a significant player in this space. Clomiphene citrate is primarily prescribed for ovulation induction in women with infertility and is also used off-label to treat hypogonadism in men.
Key Market Characteristics:
- Established Market: The drug has been available for decades, ensuring a consistent demand from the medical community and patients.
- Generic Penetration: Due to the expiration of primary patents, the market has a strong presence of generic alternatives, driving competitive pricing.
- Therapeutic Uses:
- Ovulation induction (primary approved use).
- Treatment of hypogonadism in men (off-label use, significant market share).
- Other investigational uses are being explored, which could lead to future market expansion.
- Manufacturer Landscape: Multiple generic manufacturers produce clomiphene citrate tablets, competing with Teva's branded product. The FDA's Abbreviated New Drug Application (ANDA) pathway facilitates generic market entry.
The competitive landscape influences pricing, with generic versions typically priced lower than the branded equivalent. The demand is driven by its efficacy and relatively low cost compared to newer fertility treatments or hormonal therapies.
Who Are the Key Manufacturers of Clomiphene Citrate Tablets?
The market for clomiphene citrate tablets includes several manufacturers, reflecting the generic nature of the compound. While Teva Pharmaceuticals USA, Inc. is a prominent supplier with NDC 00054-0508, other companies also produce and distribute generic versions.
Key Manufacturers:
- Teva Pharmaceuticals USA, Inc.: Markets the product under NDC 00054-0508.
- Amneal Pharmaceuticals: A significant generic drug manufacturer with clomiphene citrate offerings.
- Sun Pharmaceutical Industries: Another major generic producer with clomiphene citrate products.
- Endo Pharmaceuticals: Also has a presence in the clomiphene citrate market.
- Various smaller generic pharmaceutical companies: The accessible manufacturing processes allow for a fragmented market.
The presence of multiple suppliers intensifies competition, impacting market share and pricing strategies. The FDA's approval process for ANDAs ensures that generic versions meet the same safety, efficacy, and quality standards as the reference listed drug.
What Are the Current Pricing Trends for Clomiphene Citrate 50mg Tablets?
Pricing for clomiphene citrate 50mg tablets is heavily influenced by generic competition. The average wholesale price (AWP) for Teva's branded product (NDC 00054-0508) is generally higher than its generic counterparts. However, net prices, after rebates and discounts, often bring branded prices closer to generic levels for insured patients.
Pricing Observations:
- Branded vs. Generic: Teva's Clomiphene Citrate 50mg Tablets (NDC 00054-0508) typically command a higher list price than generic versions.
- Wholesale Acquisition Cost (WAC) & AWP: WAC for Teva's product can range from approximately $150 to $250 for a bottle of 30 tablets, with AWP being higher.
- Generic Pricing: Generic clomiphene citrate 50mg tablets are available at significantly lower price points, often ranging from $10 to $50 for a bottle of 30 tablets, depending on the manufacturer and contract terms.
- Market Dynamics: The intense competition among generic manufacturers drives down prices. The availability of multiple FDA-approved generic options ensures a competitive marketplace.
- Inflation and Supply Chain: While generally stable, prices can experience minor fluctuations due to manufacturing costs, supply chain disruptions, and inflationary pressures. However, the inherent competitiveness of the generic market limits significant price increases.
The dispensing fees and formularies of various insurance providers also play a role in the out-of-pocket cost for patients. For self-paying individuals, the price differential between branded and generic clomiphene citrate remains substantial.
What Are the Projected Market Dynamics and Price Projections for NDC 00054-0508?
Given that the core patents for clomiphene citrate have long expired and no significant new patent protection is expected for the standard 50mg tablet formulation, the market dynamics for NDC 00054-0508 are projected to remain largely unchanged in the near to medium term. The market will continue to be dominated by generic competition.
Market Projections:
- Sustained Generic Dominance: The market will continue to favor generic clomiphene citrate due to its cost-effectiveness. Teva's product will compete on brand recognition, established supply chains, and potentially specific payer contracts.
- Stable Demand: Demand for clomiphene citrate is expected to remain stable, driven by its established efficacy in treating infertility and hypogonadism. The increasing awareness and diagnosis of male hypogonadism may contribute to a slight increase in overall market volume.
- Price Erosion: The presence of multiple generic manufacturers will continue to exert downward pressure on prices for both branded and generic versions. Net prices for Teva's product may further align with generic price points through managed care agreements and discounts.
- No Significant Price Surges Expected: Without new patent filings or significant market-exclusivity extensions, dramatic price increases for the standard 50mg tablet are unlikely. Any price movements will likely be incremental, influenced by manufacturing costs and general inflation.
- Potential for New Formulations/Uses: While the current analysis focuses on the 50mg tablet, future market shifts could occur if novel formulations (e.g., extended-release) or new FDA-approved therapeutic uses for clomiphene citrate emerge, potentially protected by new patents. However, these would represent distinct product lines.
Price Projections:
- Branded (Teva NDC 00054-0508): While list prices may remain relatively consistent, net prices are expected to continue to be competitive with generics, potentially seeing a slight decrease or holding steady due to payer negotiations. Projections suggest WAC remaining in the $150-$250 range for a 30-tablet count, with net prices potentially closer to $50-$100 for insured populations.
- Generic: Prices for generic clomiphene citrate 50mg tablets are anticipated to remain low, likely within the $10-$50 range for a 30-tablet count. Slight fluctuations based on competitive bidding and manufacturing costs are possible, but significant upward trends are not projected.
The market for NDC 00054-0508 will continue to be a mature, price-sensitive segment of the pharmaceutical industry.
How Will Increased Generic Competition Affect Teva's Clomiphene Citrate?
Increased generic competition for clomiphene citrate 50mg tablets directly impacts Teva Pharmaceuticals' market position for NDC 00054-0508 by intensifying price pressures and potentially reducing market share. As more generic manufacturers enter or maintain their presence, the overall supply increases, leading to a more competitive pricing environment.
Impacts of Increased Generic Competition:
- Price Reductions: To remain competitive, Teva may need to adjust its pricing strategies, offering deeper discounts or rebates to secure payer formulary placement and physician prescribing preference. This will likely lead to a reduction in net revenue per unit sold.
- Market Share Erosion: While Teva's product benefits from established brand recognition and distribution, generic alternatives often attract price-sensitive prescribers and patients. This can lead to a gradual decline in Teva's market share if it cannot differentiate through value-added services or favorable contracts.
- Focus on Volume and Efficiency: Teva's strategy may shift towards maintaining high sales volumes at lower margins, emphasizing efficient manufacturing and distribution to remain profitable.
- Managed Care Contracts: The company will likely rely heavily on securing favorable contracts with pharmacy benefit managers (PBMs) and insurance companies to ensure broad access and preferred formulary status, thereby mitigating some of the direct price competition.
- Potential Differentiation: Teva might focus on supply chain reliability, quality control assurances, or patient support programs as a means of differentiating its product beyond price, although these factors are often less influential in the generic market.
The fundamental dynamic is that with no new patent protections, Teva's clomiphene citrate operates in a commoditized segment of the pharmaceutical market where price is a primary determinant of prescribing behavior.
What are the Key Takeaways?
The market for NDC 00054-0508 (Teva's Clomiphene Citrate 50mg Tablets) is characterized by a mature, off-patent drug facing significant and ongoing generic competition. Key takeaways for R&D and investment decisions include:
- No New Patent Exclusivity: The fundamental compound and standard formulation of clomiphene citrate are off-patent, with no anticipated new patent expirations that would grant market exclusivity to Teva's current product.
- Intense Generic Competition: Multiple manufacturers produce generic clomiphene citrate, leading to a highly competitive market with low pricing.
- Price Sensitivity: The market is price-sensitive, with generic versions significantly undercutting the list price of Teva's branded product. Net prices for Teva are likely to remain competitive with generics through payer contracts.
- Stable Demand: Demand for clomiphene citrate for its approved and off-label uses is expected to remain stable, driven by its therapeutic efficacy.
- Limited Upside for Standard Formulation: Without new therapeutic indications or patented novel formulations, significant price appreciation or market expansion for the standard 50mg tablet is unlikely.
- Focus on Operational Efficiency: For manufacturers, success in this market hinges on efficient production, robust distribution, and effective managed care strategies to navigate pricing pressures.
Frequently Asked Questions
1. What is the primary therapeutic indication for clomiphene citrate 50mg tablets? The primary FDA-approved indication is for the induction of ovulation in women with infertility. It is also widely used off-label for the treatment of hypogonadism in men.
2. Can new patents be issued for clomiphene citrate, affecting its market? While patents for the original compound have expired, new patents can be issued for novel uses, specific polymorphic forms, or unique manufacturing processes. However, these would likely apply to different product versions, not necessarily extending exclusivity for the standard 50mg tablet.
3. How does the pricing of Teva's clomiphene citrate compare to generic versions? Teva's product (NDC 00054-0508) typically has a higher list price. However, due to payer negotiations and discounts, the net price often becomes competitive with, or even approaches, that of generic clomiphene citrate tablets for insured patients.
4. Are there any known supply chain risks associated with clomiphene citrate? As a widely manufactured generic drug, the supply chain is generally robust with multiple manufacturers. However, as with any pharmaceutical product, rare disruptions due to raw material shortages, manufacturing issues, or geopolitical events are possible, though not currently a significant concern for this drug.
5. What are the regulatory requirements for a company to market a generic version of clomiphene citrate? Companies must file an Abbreviated New Drug Application (ANDA) with the FDA, demonstrating that their generic product is bioequivalent to the reference listed drug (Teva's Clomiphene Citrate 50mg Tablets in this case) and meets all quality and manufacturing standards.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from www.accessdata.fda.gov/scripts/cder/ob/default.cfm
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