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Last Updated: December 27, 2024

PROSTEP Drug Patent Profile


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When do Prostep patents expire, and what generic alternatives are available?

Prostep is a drug marketed by Aveva and is included in one NDA.

The generic ingredient in PROSTEP is nicotine. There are thirty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicotine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prostep

A generic version of PROSTEP was approved as nicotine by DIFGEN PHARMS on October 20th, 1997.

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Summary for PROSTEP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
Patent Applications: 4,047
DailyMed Link:PROSTEP at DailyMed
Drug patent expirations by year for PROSTEP

US Patents and Regulatory Information for PROSTEP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-004 Dec 23, 1998 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

International Patents for PROSTEP

See the table below for patents covering PROSTEP around the world.

Country Patent Number Title Estimated Expiration
Ireland 871119 ⤷  Subscribe
Australia 1534988 ⤷  Subscribe
Norway 179963 ⤷  Subscribe
Ireland 57786 METHOD FOR THE TREATMENT OF WITHDRAWAL SYMPTOMS ASSOCIATED WITH SMOKING CESSATION AND PREPARATIONS FOR USE IN SAID METHOD ⤷  Subscribe
Australia 607214 ⤷  Subscribe
Japan S646216 THERAPY FOR ABSTINENCE SYMPTOM RELATED TO NO SMOKING AND MEDICINE THEREFOR ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

PROSTEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Therapeutic Drugs: Lessons from Similar Markets

When analyzing the market dynamics and financial trajectory of therapeutic drugs, it is crucial to consider various factors, including competition, innovation, pricing, and patient access. Here, we will draw lessons from several therapeutic markets to understand these dynamics better.

Market Competition and Innovation

Therapeutic Modalities and Market Share

In the context of therapeutic drugs, the competition often revolves around different modalities. For example, in the Spinal Muscular Atrophy (SMA) market, drugs like Spinraza, Zolgensma, and Evrysdi compete based on efficacy, convenience, and cost. Despite Spinraza's first-mover advantage, newer entrants with better long-term efficacy and convenience are gaining market share. This competition has expanded the total SMA market by nearly 50% in just two years, from $3.0 billion in 2020 to $4.4 billion in 2022[1].

Emerging Competition in Other Therapeutic Areas

Similar competitive dynamics are expected in other therapeutic areas such as Factor XI anticoagulation, hypercholesterolemia, Alpha1 antitrypsin deficiency, CD19+ tumors, and autoimmunity. Companies with programmable modalities may have an edge in developing de-risked drugs faster and cheaper, which can significantly impact market share[1].

Pricing Strategies and Patient Access

High-Cost Therapeutics and Access Challenges

The GLP-1 market, for instance, is characterized by high drug prices, with treatments costing around $15,000 per year. This high cost limits patient access, especially in regions with single-payer healthcare systems. Despite these challenges, the market is projected to reach $100 billion globally, driven by the drugs' benefits for various health conditions beyond weight loss, such as cardiovascular and kidney disease[3].

Impact of Pricing on Market Size

Pricing strategies play a critical role in determining market size. In the GLP-1 market, while current prices are high, the potential introduction of oral GLP-1s and increased competition could lead to lower prices, making these treatments more accessible to a broader patient population. This could offset the impact of lower prices on overall market size[3].

Market Growth and Forecast

Insomnia Treatment Market

The insomnia treatment market is another example where market dynamics are influenced by patent exclusivity and the introduction of new treatments. The loss of patent exclusivity for drugs like Belsomra and Dayvigo will allow cheaper generic versions to enter the market, potentially eroding sales for branded drugs. However, the launch of new pipeline therapies is expected to fuel market growth[4].

Gaucher Disease Market

In the Gaucher disease market, the launch of new treatments like venglustat malate is anticipated to drive steady market growth. Venglustat malate, as the first brain-penetrant substrate reduction therapy (SRT), addresses significant unmet needs in neuropathic symptoms, contributing to market expansion[4].

Supply and Demand Dynamics

Supply Shortages and Demand

The initial supply shortages in the GLP-1 market, following the FDA approval of Wegovy, highlighted the importance of ramping up supply to meet demand. Drug companies are working to address these shortages, but it remains a challenging task. Ensuring a stable supply is crucial to maintaining market growth and patient access[3].

Financial Trajectory

Revenue Projections and Growth

The financial trajectory of therapeutic drugs is often tied to their market size and growth potential. For example, the GLP-1 market is projected to reach $100 billion globally, driven by promising clinical outcomes and expanding patient populations. This projection is less controversial now due to additional outcomes studies demonstrating significant health benefits[3].

Impact of Competition on Revenue

Competition within therapeutic markets can lead to revenue shifts. In the SMA market, while Biogen remains the revenue leader with Spinraza, newer entrants are taking market share. However, the overall market expansion benefits all players, as more patients gain access to treatments[1].

Patient-Centric Approaches

Patient-Generated Health Data (PGHD)

The use of patient-generated health data (PGHD) is becoming increasingly important in managing chronic conditions. Studies like the PROStep trial demonstrate the feasibility and acceptability of remote PGHD collection and its impact on patient symptom understanding and communication with clinicians. Such approaches can enhance patient care and potentially influence market dynamics by improving treatment outcomes and patient satisfaction[5].

Key Takeaways

  • Competition and Innovation: New therapeutic modalities can significantly impact market share and overall market size.
  • Pricing Strategies: High drug prices can limit patient access, but lower prices due to competition or new formats can expand the market.
  • Market Growth: The introduction of new treatments and the loss of patent exclusivity can drive market growth despite challenges.
  • Supply and Demand: Ensuring a stable supply is crucial to maintaining market growth and patient access.
  • Financial Trajectory: Revenue projections are influenced by market size, growth potential, and competition.
  • Patient-Centric Approaches: The use of PGHD can enhance patient care and influence market dynamics.

FAQs

What are the key factors influencing the market dynamics of therapeutic drugs?

The key factors include competition among different therapeutic modalities, pricing strategies, patient access, supply and demand dynamics, and the introduction of new treatments.

How does the loss of patent exclusivity affect the market?

The loss of patent exclusivity allows cheaper generic versions to enter the market, potentially eroding sales for branded drugs but also driving market growth through increased accessibility.

What role do new therapeutic modalities play in market expansion?

New therapeutic modalities can expand the overall market by offering better efficacy, convenience, and cost profiles, attracting more patients to treatment.

How do high drug prices impact patient access and market size?

High drug prices can limit patient access, but the potential introduction of lower-priced alternatives or new formats can make treatments more accessible, offsetting the impact on market size.

What is the significance of patient-generated health data (PGHD) in therapeutic markets?

PGHD can enhance patient care by improving symptom understanding and communication between patients and clinicians, potentially influencing market dynamics through better treatment outcomes and patient satisfaction.

More… ↓

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