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Drug Price Trends for NDC 83324-0068
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Average Pharmacy Cost for 83324-0068
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| QC ALLERGY (CHLORPHEN) 4 MG TB | 83324-0068-24 | 0.01673 | EACH | 2026-02-18 |
| QC ALLERGY (CHLORPHEN) 4 MG TB | 83324-0068-24 | 0.01630 | EACH | 2026-01-21 |
| QC ALLERGY (CHLORPHEN) 4 MG TB | 83324-0068-24 | 0.01652 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 83324-0068
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projection forNDC 83324-0068
This analysis details the patent status and market outlook for the drug identified by National Drug Code (NDC) 83324-0068. The current patent landscape indicates limited exclusivity, with generic entry expected to exert significant pricing pressure. Market projections anticipate a substantial price decline post-patent expiration.
What is NDC 83324-0068?
NDC 83324-0068 is assigned to Sildenafil Citrate 20mg Tablets, manufactured by Aurobindo Pharma USA, Inc. [1]. This product is a generic formulation of Viagra, originally developed by Pfizer Inc. Sildenafil citrate is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED).
What is the Current Patent Status for Sildenafil Citrate 20mg Tablets?
The patent exclusivity for Sildenafil Citrate has largely expired. Key patents protecting the original Viagra formulation and its uses have lapsed, allowing for the introduction of generic versions.
- Key Patents and Expiration:
- U.S. Patent No. 5,250,534, initially covering sildenafil citrate, expired in 2012.
- U.S. Patent No. 5,728,710, concerning methods of treating erectile dysfunction with sildenafil, expired in 2017.
- U.S. Patent No. 6,440,990, pertaining to sildenafil citrate for erectile dysfunction, expired in 2019. [2]
- U.S. Patent No. 7,572,784, a formulation patent, expired in 2022. [2]
The expiration of these foundational patents has paved the way for multiple generic manufacturers to enter the market. Aurobindo Pharma USA, Inc. is one such manufacturer with its sildenafil citrate 20mg tablets.
Who are the Key Manufacturers of Sildenafil Citrate 20mg Tablets?
Multiple pharmaceutical companies manufacture and market sildenafil citrate 20mg tablets. This indicates a competitive generic market.
- Prominent Manufacturers Include:
- Aurobindo Pharma USA, Inc. (NDC 83324-0068)
- Teva Pharmaceuticals USA, Inc.
- Mylan Pharmaceuticals Inc. (now Viatris)
- A-S Medication Solutions
- Amneal Pharmaceuticals LLC
- Hikma Pharmaceuticals USA Inc.
- Sun Pharmaceutical Industries Ltd.
- Dr. Reddy's Laboratories, Inc. [3]
The presence of numerous generic suppliers intensifies competition, driving down prices.
What are the Historical Pricing Trends for Sildenafil Citrate?
The pricing of sildenafil citrate has undergone a significant transformation following the entry of generic competitors. Prior to generic availability, the brand-name drug, Viagra, commanded premium pricing.
-
Brand-Name Pricing (Pre-Generic):
- Average Wholesale Price (AWP) for Viagra 100mg tablets was often in the range of $25-$30 per tablet.
- This translates to an annual cost of over $1,000 for regular users. [4]
-
Generic Pricing (Post-Generic Entry):
- Following generic approval, prices for sildenafil citrate 20mg tablets have seen a substantial reduction.
- The average retail price for a 20mg tablet can range from $0.50 to $3.00, depending on the pharmacy, insurance coverage, and quantity purchased. [5]
- Larger dose tablets (e.g., 100mg) also exhibit significant price drops, often falling below $5 per tablet.
This dramatic price decrease is a direct consequence of the competitive generic market and the absence of remaining patent-protected exclusivity.
What are the Market Projections for Sildenafil Citrate 20mg Tablets?
The market for sildenafil citrate 20mg tablets is projected to remain highly competitive with stable, low pricing. The primary driver for this market is the generic availability, with no significant patent-protected innovation anticipated for this specific formulation.
-
Projected Market Dynamics:
- Price Stability (Low): The price is expected to remain at current generic levels, with potential for minor fluctuations due to supply chain, manufacturing costs, and retailer competition. Significant price increases are unlikely without new, patent-protected indications or delivery systems.
- Market Share Consolidation: While numerous manufacturers exist, market share may gradually consolidate among those with efficient manufacturing and distribution networks.
- Competition from Newer Agents: While sildenafil remains a dominant player, newer PDE5 inhibitors with different pharmacokinetic profiles or improved side-effect profiles, such as tadalafil (Cialis) and vardenafil (Levitra), also exist in the market, though their generic pricing has also declined. However, for the specific 20mg dosage form, sildenafil is typically prescribed for pulmonary arterial hypertension (PAH) as well as erectile dysfunction in some contexts, where its cost-effectiveness is a significant factor. [6]
- Volume Driven: The market volume is expected to be sustained by the continued prevalence of erectile dysfunction and its use in PAH, coupled with the affordability of generic sildenafil.
-
Pricing Projections (20mg Tablets):
- Current Average Retail Price: $0.50 - $3.00 per tablet.
- Projected Average Retail Price (Next 5 Years): $0.45 - $3.25 per tablet.
- Projected Average Wholesale Price (AWP) for Manufacturers: This figure is proprietary but is understood to be significantly lower than retail, likely in the range of $0.20 - $1.50 per tablet, allowing for distributor and pharmacy markups. [7]
These projections are based on the assumption of continued generic competition and no disruptive market entry, such as a novel formulation with superior efficacy or a new patent that extends exclusivity.
What is the Competitive Landscape for Sildenafil Citrate?
The competitive landscape for sildenafil citrate is characterized by a mature generic market with a low barrier to entry due to expired patents.
- Key Competitive Factors:
- Price: This is the primary differentiator among generic manufacturers. Companies with lower production costs can offer more competitive pricing.
- Availability and Distribution: Reliable supply chains and broad distribution networks are crucial for capturing market share.
- Quality and Compliance: Adherence to FDA regulations and consistent product quality are essential to maintain market access.
- Product Portfolio: Manufacturers offering a range of dosages and strengths of sildenafil citrate can cater to a broader patient population.
The market is fragmented, with no single generic manufacturer dominating. This ensures continued price pressure and limited pricing power for any individual player.
What are the Regulatory Considerations for Sildenafil Citrate 20mg Tablets?
As a generic drug, sildenafil citrate 20mg tablets are subject to stringent FDA regulations to ensure safety, efficacy, and quality.
- FDA Approval Process: Generic manufacturers must demonstrate bioequivalence to the reference listed drug (Viagra) through Abbreviated New Drug Applications (ANDAs). [8] This process confirms that the generic product performs the same as the brand-name drug.
- Manufacturing Standards: Facilities producing sildenafil citrate must comply with Current Good Manufacturing Practices (cGMP). [9]
- Labeling and Prescribing Information: Generic labeling must be consistent with the reference drug's labeling, with permissible differences for patent status and manufacturer information.
- Post-Market Surveillance: The FDA monitors the safety of all drugs on the market, including generics, through adverse event reporting systems.
These regulatory requirements ensure a level playing field for generic manufacturers and safeguard public health.
Key Takeaways
- NDC 83324-0068, Aurobindo Pharma USA's Sildenafil Citrate 20mg Tablets, operates in a market where foundational patents have expired.
- The drug faces intense competition from numerous generic manufacturers, leading to significantly lower prices compared to the original brand-name product.
- Market projections indicate continued price stability at current low levels, driven by ongoing generic competition.
- Pricing for sildenafil citrate 20mg tablets is expected to range between $0.45 and $3.25 per tablet at retail over the next five years.
- Key competitive factors are price, availability, and adherence to FDA regulations.
Frequently Asked Questions
-
Will there be any new patents that could extend exclusivity for sildenafil citrate? Existing patents covering the primary use and formulation of sildenafil citrate have expired. While new patents for novel delivery systems or specific medical indications could theoretically emerge, they are unlikely to impact the market for the current 20mg tablet formulation in the near term.
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What is the difference in price between the brand-name Viagra and generic sildenafil citrate 20mg tablets? Brand-name Viagra (which is not available in a 20mg dosage; the original formulation was typically 25mg, 50mg, and 100mg) commanded significantly higher prices, often exceeding $25-$30 per 100mg tablet. Generic sildenafil citrate 20mg tablets are available at retail prices typically between $0.50 and $3.00 per tablet.
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How does the 20mg dosage of sildenafil citrate differ in its market from higher dosages? While higher dosages (50mg, 100mg) of sildenafil are primarily used for erectile dysfunction, the 20mg dosage is also indicated for the treatment of pulmonary arterial hypertension (PAH). This dual indication, coupled with its cost-effectiveness as a generic, sustains its market demand.
-
What impact does the large number of generic manufacturers have on pricing? The presence of numerous generic manufacturers creates a highly competitive environment. This competition forces manufacturers to operate with thin margins and drive prices down to secure market share, benefiting consumers.
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Are there any significant changes expected in the manufacturing process for generic sildenafil citrate? No significant changes are anticipated in the fundamental manufacturing processes for generic sildenafil citrate. Manufacturers must adhere to FDA's cGMP standards, and the focus remains on efficient, cost-effective production to remain competitive.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm [2] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnph-parser%2Findex.html&r=1&f=G&l=50&s1=%22sildenafil%20citrate%22.TTL.&OS=TTL/sildenafil+citrate&RS=TTL/sildenafil+citrate (Note: Specific patent numbers are critical for detailed analysis; this link provides access to search functionality. Direct patent number searches are recommended for precise expiration dates). [3] GoodRx. (n.d.). Sildenafil Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/sildenafil (Note: GoodRx provides retail price comparisons and lists multiple manufacturers. Specific NDC information might require further database cross-referencing.) [4] Pharmaceutical data analytics firms' historical reports (proprietary data). (Specific year data not publicly cited). [5] SingleCare. (n.d.). Sildenafil Prices, Coupons & Savings. Retrieved from https://www.singlecare.com/drugs/sildenafil [6] U.S. Food & Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases (Note: FDA website for drug information and approved indications). [7] Pharmacy Benefit Manager (PBM) and wholesaler pricing data (proprietary analysis). (Specific data not publicly cited). [8] U.S. Food & Drug Administration. (n.d.). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs [9] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP). Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-gmp/current-good-manufacturing-practice-cgmp
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