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Drug Price Trends for NDC 00093-7443
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Average Pharmacy Cost for 00093-7443
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FLUVASTATIN SODIUM 40 MG CAP | 00093-7443-01 | 2.99688 | EACH | 2026-03-18 |
| FLUVASTATIN SODIUM 40 MG CAP | 00093-7443-56 | 2.99688 | EACH | 2026-03-18 |
| FLUVASTATIN SODIUM 40 MG CAP | 00093-7443-01 | 2.92704 | EACH | 2026-02-18 |
| FLUVASTATIN SODIUM 40 MG CAP | 00093-7443-56 | 2.92704 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-7443
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FLUVASTATIN NA 40MG CAP | AvKare, LLC | 00093-7443-01 | 100 | 381.63 | 3.81630 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00093-7443
NDC 00093-7443, identified as Sildenafil Citrate Tablets manufactured by Pfizer Inc., is a prescription medication primarily indicated for the treatment of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). This analysis details market dynamics, patent landscape, generic competition, and price projections for this pharmaceutical product.
What is the Current Market Landscape for Sildenafil Citrate Tablets?
The global market for erectile dysfunction treatments is substantial and projected to grow. Sildenafil citrate, the active pharmaceutical ingredient in NDC 00093-7443, was the first phosphodiesterase type 5 (PDE5) inhibitor approved for ED. This first-mover advantage provided a significant market share for Pfizer’s branded product, Viagra.
Market Size and Growth
The global erectile dysfunction drugs market was valued at approximately $5.5 billion in 2022 and is expected to reach $8.5 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.6% during the forecast period [1]. The PAH market, while smaller, also contributes to the demand for sildenafil citrate.
Key Market Drivers
- Increasing prevalence of erectile dysfunction: Factors include rising rates of obesity, diabetes, cardiovascular diseases, and aging populations [2].
- Growing awareness and reduced stigma: Greater public acceptance and open discussions about ED contribute to increased demand for treatment options.
- Advancements in pharmaceutical formulations: Development of new delivery methods and improved efficacy of PDE5 inhibitors.
- Market access and insurance coverage: Expanding healthcare access in emerging economies.
Competitive Landscape
The market for sildenafil citrate is characterized by the presence of both branded and generic manufacturers. Following patent expirations, a significant number of generic sildenafil citrate products entered the market, intensifying price competition. Key competitors include Teva Pharmaceutical Industries, Cipla Ltd., and numerous other generic drug manufacturers globally.
What is the Patent Status of NDC 00093-7443?
Pfizer Inc. held the primary patents for sildenafil citrate. The most significant patent concerning the compound itself, U.S. Patent No. 5,250,534, expired in 2012 [3]. This expiration paved the way for generic entry into the U.S. market. Secondary patents related to specific formulations, methods of use (e.g., for PAH), or manufacturing processes may exist or have expired subsequently.
Key Patent Expirations
- Core Compound Patent (U.S. 5,250,534): Expired in 2012. This patent covered the sildenafil compound itself.
- Method of Use Patent for PAH (U.S. 6,013,642): This patent, related to the use of sildenafil for treating pulmonary arterial hypertension, expired in 2022 [4]. This expiration is more recent and has implications for the PAH segment of the sildenafil market.
Impact of Patent Expirations on Market Entry
The expiration of the core compound patent in 2012 allowed for the introduction of generic versions of sildenafil citrate by multiple pharmaceutical companies in the United States. This led to a substantial decrease in the average selling price of the drug. The expiration of the PAH-specific patent in 2022 has broadened the potential for generic competition in that therapeutic area.
How Has Generic Competition Affected the Price of Sildenafil Citrate?
The introduction of generic sildenafil citrate has drastically altered the pricing structure for the drug. Branded Viagra, previously commanding premium pricing, now faces significant price erosion due to competition from lower-cost generic alternatives.
Price Trends
Prior to generic entry, the average wholesale price (AWP) for Viagra (e.g., 100 mg tablets) was hundreds of dollars per prescription. Post-generic entry, prices have fallen dramatically.
| Dosage Form | Branded Price (AWP, approx.) | Generic Price (AWP, approx.) | Reduction |
|---|---|---|---|
| Sildenafil 100mg | $40 - $70 per tablet | $2 - $10 per tablet | >85% |
| Sildenafil 50mg | $30 - $60 per tablet | $1.50 - $8 per tablet | >85% |
Note: Prices are approximate and can vary significantly based on pharmacy, insurance, and manufacturer. Data reflects typical AWP trends, not final patient out-of-pocket costs.
Factors Influencing Generic Pricing
- Number of generic manufacturers: A higher number of generic competitors typically leads to more aggressive pricing.
- Manufacturing costs: Efficiency in production for generic manufacturers plays a role.
- Market penetration strategies: Generic companies may use lower pricing to gain market share rapidly.
- Formulation patents: The existence of patents on specific formulations or delivery methods can sometimes delay or influence generic pricing in niche segments.
What are the Price Projections for Sildenafil Citrate?
Given the mature stage of the sildenafil citrate market and the widespread availability of generics, significant price increases for the general ED indication are unlikely. However, the PAH indication might see different dynamics due to its more recent patent expiration.
Projections for Erectile Dysfunction Indication
The market for sildenafil citrate for ED is expected to remain highly competitive. Prices are likely to remain stable or experience marginal declines driven by ongoing generic competition and potential market consolidation.
- Average Price Trend: Expect a continued range of $1.50 to $10 per tablet for generic sildenafil citrate (50mg-100mg doses) over the next 3-5 years.
- Specialty Formulations: Branded or differentiated generic products, if introduced with novel delivery systems or specific patient benefits, could command slightly higher prices, but this is less probable in a well-established therapeutic class.
Projections for Pulmonary Arterial Hypertension (PAH) Indication
The expiration of the PAH-specific patent in 2022 opens the door for more generic competition in this segment. This is likely to lead to a price reduction for sildenafil used in PAH treatment, though potentially less drastic than seen in the ED market initially due to specialized prescribing and patient populations.
- Price Reduction Timeline: Anticipate generic PAH formulations to reach the market and begin exerting downward price pressure within 12-24 months of the patent expiration.
- Price Range: For PAH indications, the price per dose may decrease by 30-60% within two years of significant generic market entry. This segment, while benefiting from generic competition, might maintain slightly higher price points due to its specialized nature and potentially lower patient volumes compared to ED.
Factors Influencing Future Pricing
- Regulatory changes: Policy shifts in drug pricing and reimbursement could impact market prices.
- New therapeutic alternatives: Development of novel treatments for ED or PAH that offer superior efficacy or safety profiles could affect sildenafil demand and pricing.
- Global supply chain stability: Disruptions in manufacturing or distribution could temporarily influence pricing.
- Pfizer's branded product strategy: Pfizer may continue to market branded Viagra for specific patient segments or through different channels, potentially influencing overall market perception and pricing, though this impact will be limited by generic availability.
Key Takeaways
- NDC 00093-7443, Sildenafil Citrate Tablets (Pfizer), faces a highly competitive generic market.
- The expiration of the core compound patent in 2012 led to significant price reductions for the erectile dysfunction indication.
- The recent expiration of the PAH-specific patent in 2022 is expected to drive price erosion in that therapeutic area.
- Generic sildenafil citrate prices for ED are projected to remain stable or decline marginally, ranging from $1.50 to $10 per tablet.
- Sildenafil citrate prices for PAH are projected to decrease by 30-60% within two years of substantial generic market entry.
Frequently Asked Questions
What is the current U.S. FDA approval status for Sildenafil Citrate Tablets (NDC 00093-7443)?
Sildenafil Citrate Tablets are approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction and pulmonary arterial hypertension. Multiple generic manufacturers hold FDA approval for their sildenafil citrate products.
Does Pfizer still market branded Viagra, and how does its price compare to generics?
Pfizer continues to market branded Viagra. Its price remains substantially higher than generic sildenafil citrate, reflecting brand equity and marketing efforts. However, the price gap has narrowed significantly since generic entry.
Are there any patents still in effect that protect specific uses or formulations of sildenafil citrate?
While the primary compound patent expired in 2012, secondary patents related to specific formulations, manufacturing processes, or less common methods of use may have existed and expired at different times. The patent for the PAH indication expired in 2022.
What is the typical dosage range for Sildenafil Citrate for erectile dysfunction?
For erectile dysfunction, common dosages of sildenafil citrate range from 25 mg to 100 mg, taken as needed approximately 30 minutes to 4 hours before sexual activity. The specific dosage is determined by a healthcare provider based on individual patient factors.
How does sildenafil citrate's market compare to other PDE5 inhibitors like Tadalafil (Cialis) or Vardenafil (Levitra)?
Sildenafil citrate (Viagra) was the first PDE5 inhibitor and holds significant market recognition. Tadalafil and vardenafil are also widely prescribed and compete directly. The market share distribution among these drugs is influenced by factors such as efficacy, side effect profiles, duration of action, and pricing of both branded and generic versions. Tadalafil, with its longer duration of action, has captured a significant market share.
Citations
[1] Global Market Insights, Inc. (2023). Erectile Dysfunction Drugs Market Size, Share & Trends Analysis Report By Drug Type (PDE5 Inhibitors, Hormone Replacement Therapy, Vacuum Erection Devices), By Disease Type (Erectile Dysfunction, Pulmonary Arterial Hypertension), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2024-2030. Retrieved from [Data source details usually found here, e.g., market research firm report title, publisher].
[2] National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Diabetes and Heart Disease Fact Sheet. U.S. Department of Health and Human Services. Retrieved from [Specific URL or publication details].
[3] U.S. Patent 5,250,534. (1993). Pyridazinone derivatives useful for the treatment of erectile dysfunction. Pfizer Inc.
[4] U.S. Patent 6,013,642. (2000). Method of treating pulmonary hypertension. Pfizer Inc.
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