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Last Updated: December 22, 2024

ALPHATREX Drug Patent Profile


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Which patents cover Alphatrex, and when can generic versions of Alphatrex launch?

Alphatrex is a drug marketed by Savage Labs and is included in three NDAs.

The generic ingredient in ALPHATREX is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Alphatrex

A generic version of ALPHATREX was approved as betamethasone dipropionate by FOUGERA PHARMS on June 26th, 1984.

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Summary for ALPHATREX
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 50
Patent Applications: 4,380
DailyMed Link:ALPHATREX at DailyMed
Drug patent expirations by year for ALPHATREX

US Patents and Regulatory Information for ALPHATREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs ALPHATREX betamethasone dipropionate CREAM;TOPICAL 019138-001 Jun 26, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Savage Labs ALPHATREX betamethasone dipropionate LOTION;TOPICAL 070273-001 Aug 12, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Savage Labs ALPHATREX betamethasone dipropionate OINTMENT;TOPICAL 019143-001 Sep 4, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ALPHATREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alphatrex (Betamethasone Topical)

Introduction

Alphatrex, a brand name for the topical corticosteroid betamethasone, is widely used for treating various skin conditions, including mild to moderate plaque psoriasis, eczema, and other inflammatory skin diseases. Understanding the market dynamics and financial trajectory of Alphatrex involves analyzing several key factors, including market share, pricing, regulatory environment, and patient utilization.

Market Share and Competition

The market for topical corticosteroids is highly competitive, with numerous generic and branded options available. Alphatrex, being a branded product, faces competition from generic versions of betamethasone as well as other topical corticosteroids. The market share of Alphatrex can be influenced by factors such as the availability of generic alternatives, pricing strategies, and the effectiveness of the drug in treating specific skin conditions[5].

Pricing and Cost Considerations

Pricing is a critical factor in the market dynamics of pharmaceuticals. For Alphatrex, the cost can vary significantly depending on the dosage form (cream, lotion, ointment, spray) and the region. In general, branded products like Alphatrex tend to be more expensive than their generic counterparts. However, the cost-effectiveness of Alphatrex can be a selling point, especially if it offers better efficacy or fewer side effects compared to generic alternatives[5].

Impact of Generic Versions

The availability of generic versions of betamethasone can significantly impact the pricing and market share of Alphatrex. Generic drugs are typically cheaper, which can lead to a shift in market share towards the generic options. For instance, in the context of other pharmaceuticals, the delay in the availability of generic versions can maintain the market dominance of the branded product, as seen with omeprazole in the early 2000s[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Alphatrex, like other drugs, must comply with FDA regulations and guidelines. Any changes in regulatory policies or the approval of new drugs can affect the market position of Alphatrex. For example, the FDA's approval process for new drugs and the implementation of prior authorization criteria can influence how drugs are prescribed and used[3].

Patient Utilization and Side Effects

Patient utilization is another key factor in the market dynamics of Alphatrex. The drug's effectiveness and side effect profile can significantly impact its usage. Betamethasone topical is known for its efficacy in treating skin conditions, but it also comes with potential side effects such as raised, dark red, or wart-like spots on the skin, burning, itching, and pain in hairy areas, and rare ocular side effects like cataracts and glaucoma[2][5].

Side Effects and Patient Safety

The side effect profile of Alphatrex can affect patient compliance and overall market performance. Serious side effects, such as those affecting the eyes, require immediate medical attention and can lead to a decrease in patient utilization if not managed properly. Regular monitoring by healthcare professionals is essential to mitigate these risks[5].

Financial Trajectory

The financial trajectory of Alphatrex is influenced by several factors, including sales revenue, market share, and the cost of production and distribution.

Sales Revenue

Sales revenue for Alphatrex can fluctuate based on market demand, competition from generic versions, and pricing strategies. Branded products often maintain higher prices and revenue streams until generic versions become widely available.

Market Share and Revenue Impact

The market share of Alphatrex directly impacts its revenue. If Alphatrex maintains a significant market share due to its efficacy and brand loyalty, it can continue to generate substantial revenue. However, if generic versions gain traction, the revenue for Alphatrex could decline.

Cost of Production and Distribution

The cost of producing and distributing Alphatrex also affects its financial trajectory. These costs include manufacturing, marketing, and distribution expenses. Efficient management of these costs can help maintain profitability even in a competitive market.

Prior Authorization and Formulary Inclusion

Prior authorization (PA) criteria and formulary inclusion can significantly impact the financial trajectory of Alphatrex. PA requirements can limit the drug's usage, as seen with sildenafil in the TRICARE program, where utilization declined significantly after implementing PA[1].

Formulary Inclusion

Inclusion in formularies, especially those of large healthcare providers or insurance plans, is crucial for the financial success of Alphatrex. Being listed as a preferred or non-preferred drug on these formularies can influence prescription rates and revenue[3].

Public Health and Policy Implications

Public health policies and changes in healthcare regulations can also impact the market dynamics and financial trajectory of Alphatrex. For example, updates in prior authorization criteria or changes in drug classification can affect how the drug is prescribed and reimbursed.

Key Takeaways

  • Market Share: Alphatrex faces competition from generic betamethasone and other topical corticosteroids.
  • Pricing: Branded products like Alphatrex are generally more expensive than generics.
  • Regulatory Environment: Compliance with FDA regulations and changes in regulatory policies can impact market position.
  • Patient Utilization: Efficacy and side effect profile influence patient compliance and market performance.
  • Financial Trajectory: Sales revenue, market share, and production/distribution costs are key factors.
  • Prior Authorization and Formulary Inclusion: PA criteria and formulary status significantly impact usage and revenue.

FAQs

What is Alphatrex used for?

Alphatrex is used to treat mild to moderate plaque psoriasis and other inflammatory skin conditions.

What are the common side effects of Alphatrex?

Common side effects include raised, dark red, or wart-like spots on the skin, burning, itching, and pain in hairy areas. Rare side effects can include ocular issues like cataracts and glaucoma.

How does the availability of generic versions affect Alphatrex?

The availability of generic versions of betamethasone can reduce the market share and revenue of Alphatrex due to lower prices.

What role does prior authorization play in the market dynamics of Alphatrex?

Prior authorization can limit the usage of Alphatrex by requiring additional approval steps before the drug can be prescribed, potentially reducing its market share and revenue.

How does formulary inclusion impact the financial trajectory of Alphatrex?

Inclusion in formularies as a preferred or non-preferred drug can significantly influence prescription rates and revenue for Alphatrex.

Sources

  1. Department of Defense Pharmacoeconomic Center - Cumulative Minutes 2001[1]
  2. Drugs.com - Alphatrex Side Effects[2]
  3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee - Meeting Documents 2022[3]
  4. FDA - Label for Calcipotriene and Betamethasone Dipropionate[4]
  5. Mayo Clinic - Betamethasone Dipropionate Topical Application Route[5]

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