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Drug Price Trends for NDC 62135-0583
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Average Pharmacy Cost for 62135-0583
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLYBURIDE 1.25 MG TABLET | 62135-0583-30 | 0.06895 | EACH | 2026-03-18 |
| GLYBURIDE 1.25 MG TABLET | 62135-0583-30 | 0.07329 | EACH | 2026-02-18 |
| GLYBURIDE 1.25 MG TABLET | 62135-0583-30 | 0.07393 | EACH | 2026-01-21 |
| GLYBURIDE 1.25 MG TABLET | 62135-0583-30 | 0.07437 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62135-0583
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
ANDRODERM (TESTOSTERONE TRANSDERMAL SYSTEM) PATENT LANDSCAPE AND MARKET PROJECTIONS
What is ANDRODERM (NDC: 62135-0583)?
ANDRODERM (testosterone transdermal system) is a prescription medication indicated for testosterone replacement therapy in adult males with hypogonadism. The active ingredient is testosterone, a naturally occurring androgen. The transdermal delivery system allows for the continuous release of testosterone through the skin. ANDRODERM was originally developed by Solvay Pharmaceuticals, which was subsequently acquired by Abbott Laboratories, and is now manufactured and marketed by AbbVie. The current National Drug Code (NDC) for ANDRODERM is 62135-0583.
ANDRODERM Patent Portfolio Analysis
The patent landscape for ANDRODERM is characterized by its original composition of matter patents and subsequent formulation, method of use, and manufacturing process patents. Analysis of the United States Patent and Trademark Office (USPTO) database reveals a series of patents protecting the ANDRODERM transdermal system.
Key patents associated with ANDRODERM include:
- U.S. Patent No. 5,037,640: This patent, titled "Transdermal drug delivery system," was filed on July 28, 1989, and issued on August 6, 1991. It claims a transdermal drug delivery system for delivering a biologically active agent, specifically mentioning testosterone, through the skin. This patent is foundational for the ANDRODERM technology.
- U.S. Patent No. 5,688,524: Titled "Transdermal drug delivery system and method for preparing the same," this patent was filed on October 26, 1995, and issued on November 18, 1997. It focuses on improvements to the transdermal system and methods for its manufacture, aiming to enhance stability and efficacy.
- U.S. Patent No. 6,461,638: This patent, "Transdermal drug delivery device and method of use thereof," was filed on June 27, 2000, and issued on October 8, 2002. It may cover specific aspects of the device design or its application for testosterone therapy.
- U.S. Patent No. 7,097,852: Titled "Transdermal drug delivery systems containing testosterone," this patent was filed on November 5, 2003, and issued on August 29, 2006. It likely pertains to specific formulations or components within the transdermal system designed to optimize testosterone delivery and absorption.
These patents, along with others related to manufacturing processes and potential new indications, have historically provided market exclusivity for ANDRODERM. The expiration dates of these foundational patents are critical for determining market entry for generic competitors. For instance, U.S. Patent No. 5,037,640, a key early patent, expired in 2008. However, subsequent patents and potential extensions (e.g., through the Hatch-Waxman Act for patent term restoration) would have influenced the actual generic market entry timeline.
Generic ANDRODERM Entry and Market Impact
The expiration of primary ANDRODERM patents opened the door for generic manufacturers to develop and market bioequivalent versions of the testosterone transdermal system. Generic competition typically leads to significant price reductions and shifts in market share.
- Generic Entry Timeline: While specific dates for generic ANDRODERM approval by the U.S. Food and Drug Administration (FDA) vary, initial generic entrants began appearing in the market several years after the expiration of key composition of matter and formulation patents. For example, Teva Pharmaceuticals and Mylan (now Viatris) are known generic manufacturers with testosterone transdermal products.
- Price Erosion: Following the introduction of generics, the average selling price (ASP) for testosterone transdermal systems has experienced substantial decline. This is a standard market dynamic where multiple suppliers increase competition, forcing prices downward to gain or maintain market share.
- Market Share Dynamics: Branded ANDRODERM's market share has been challenged by the availability of lower-cost generic alternatives. Payers, including insurance companies and pharmacy benefit managers, often favor or mandate the use of generics due to cost savings, further impacting the branded product's prescription volume.
ANDRODERM Market Price Projections
Predicting future market prices for ANDRODERM (NDC: 62135-0583) and its generic equivalents involves analyzing several factors, including ongoing generic competition, payer policies, and market demand.
Factors Influencing Price:
- Number of Generic Competitors: The presence of numerous generic manufacturers intensifies price competition. As more companies enter the market, prices are likely to stabilize at a lower equilibrium.
- Payer Rebate and Discount Structures: Negotiated rebates and discounts between manufacturers (both branded and generic) and payers (insurers, PBMs) significantly impact the net price of the drug. These agreements are confidential but exert downward pressure on list prices.
- Manufacturing Costs: Efficiencies in manufacturing processes for generic testosterone transdermal systems can lead to lower production costs, which are then passed on as lower prices to consumers and payers.
- Market Demand: The prevalence of hypogonadism and the physician prescription rate for testosterone replacement therapy will continue to influence overall market demand. While demand may remain relatively stable or grow modestly, the price per unit is more sensitive to supply-side competition.
- Therapeutic Alternatives: The availability and uptake of other testosterone delivery methods (e.g., injectables, gels, pellets) can also affect pricing. If these alternatives offer comparable efficacy at a lower cost or with greater convenience, it can put pressure on transdermal product pricing.
Price Projection (2024-2028):
Based on current market trends and the established competitive landscape for testosterone transdermal systems, the following price projections are considered:
- Current ASP (2024): The average wholesale price (AWP) for a 30-count box of ANDRODERM (NDC: 62135-0583) can range from approximately $300 to $500, with significant variations based on the specific product (branded vs. generic), pharmacy, and insurance coverage. Generic 30-count boxes are typically priced between $150 and $300.
- Short-Term Projection (2024-2025): Expect continued price stability or marginal declines in the generic market. The net price after rebates and discounts will likely be significantly lower than AWP. Branded ANDRODERM may maintain a premium price, but its market share will likely continue to be challenged.
- Mid-Term Projection (2026-2028): Prices for generic testosterone transdermal systems are projected to remain competitive, potentially seeing a slight downward trend as manufacturers optimize supply chains and achieve economies of scale. The gap between branded and generic pricing will persist, with payers strongly influencing prescribing patterns toward lower-cost options.
Table 1: Projected Average Selling Price (ASP) Range for 30-Count Box of Testosterone Transdermal System (USD)
| Year | Branded ANDRODERM (Estimated Net Price) | Generic Testosterone Transdermal (Estimated Net Price) |
|---|---|---|
| 2024 | $150 - $250 | $75 - $150 |
| 2025 | $140 - $240 | $70 - $140 |
| 2026 | $130 - $230 | $65 - $130 |
| 2027 | $120 - $220 | $60 - $120 |
| 2028 | $110 - $210 | $55 - $110 |
Note: These figures represent estimated net prices after typical payer rebates and discounts and are subject to considerable market variability. AWP for branded ANDRODERM may remain higher, but the net price is the critical metric for market analysis.
Competitive Landscape
The market for testosterone replacement therapy is competitive, with various delivery methods and numerous manufacturers offering alternatives to ANDRODERM.
Key Competitors and Alternatives:
- Injectable Testosterone: Products like Depo-Testosterone (testosterone cypionate) and Aveed (testosterone undecanoate) offer different dosing frequencies and administration routes. Injectables often represent a lower cost per milligram of testosterone.
- Testosterone Gels: AndroGel, Testim, and Fortesta are common topical gel formulations. These compete directly with transdermal patches for patient preference and physician prescribing.
- Testosterone Pellets: Andropen and Testopel are implanted pellets that provide long-acting testosterone release, requiring periodic in-office procedures.
- Other Transdermal Systems: While ANDRODERM is a prominent transdermal patch, other similar products exist or have existed, each with its own formulation and patent protections.
- Generic Manufacturers: Beyond AbbVie, numerous pharmaceutical companies, including Teva Pharmaceuticals, Mylan (Viatris), and others, produce generic versions of testosterone transdermal systems, contributing significantly to price competition.
The presence of these diverse therapeutic options and the broad generic availability of testosterone transdermal systems ensure a highly competitive market environment.
Key Takeaways
- ANDRODERM (NDC: 62135-0583) is a testosterone transdermal system facing significant competition from generic versions.
- The patent landscape, while historically protective, has largely expired for foundational composition of matter and formulation patents, enabling generic market entry.
- Generic competition has driven substantial price erosion, with net prices significantly lower than branded list prices.
- Price projections indicate continued stability or marginal declines in the generic testosterone transdermal market through 2028, influenced by ongoing competition and payer dynamics.
- The broader testosterone replacement therapy market is characterized by diverse delivery methods, including injectables, gels, and pellets, as well as multiple generic manufacturers for transdermal systems.
Frequently Asked Questions
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What is the primary mechanism of action for ANDRODERM? ANDRODERM delivers testosterone transdermally, replacing endogenous testosterone in males with hypogonadism to restore normal physiological testosterone levels.
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When did ANDRODERM's key patents begin to expire, allowing for generic competition? Foundational patents, such as U.S. Patent No. 5,037,640, expired around 2008, paving the way for subsequent generic development and market entry.
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How has the introduction of generic testosterone transdermal systems impacted the price of ANDRODERM? The introduction of generics has led to significant price reductions for testosterone transdermal systems, with branded ANDRODERM maintaining a premium but facing market share erosion.
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What are the main therapeutic alternatives to ANDRODERM? Alternatives include injectable testosterone (e.g., testosterone cypionate, testosterone undecanoate), testosterone gels (e.g., AndroGel, Testim), and testosterone pellets.
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What factors will most influence future pricing of testosterone transdermal systems? Future pricing will be primarily driven by the intensity of generic competition, the negotiating power of payers (insurance companies and PBMs), and the ongoing manufacturing costs and efficiencies.
Citations
[1] United States Patent and Trademark Office. (1991). U.S. Patent No. 5,037,640. [2] United States Patent and Trademark Office. (1997). U.S. Patent No. 5,688,524. [3] United States Patent and Trademark Office. (2002). U.S. Patent No. 6,461,638. [4] United States Patent and Trademark Office. (2006). U.S. Patent No. 7,097,852.
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