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Last Updated: December 23, 2024

NILANDRON Drug Patent Profile


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When do Nilandron patents expire, and when can generic versions of Nilandron launch?

Nilandron is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in NILANDRON is nilutamide. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nilutamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nilandron

A generic version of NILANDRON was approved as nilutamide by ANI PHARMS on July 15th, 2016.

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Summary for NILANDRON
Drug patent expirations by year for NILANDRON
Drug Prices for NILANDRON

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Recent Clinical Trials for NILANDRON

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SponsorPhase
Southwest Oncology GroupPhase 3
NRG OncologyPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3

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Pharmacology for NILANDRON

US Patents and Regulatory Information for NILANDRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia NILANDRON nilutamide TABLET;ORAL 020169-001 Sep 19, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia NILANDRON nilutamide TABLET;ORAL 020169-002 Apr 30, 1999 AB RX Yes Yes ⤷  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

NILANDRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Androgen Deprivation Therapy: A Focus on NILANDRON

Introduction

Androgen deprivation therapy (ADT) is a crucial treatment approach for prostate cancer, and drugs like NILANDRON play a significant role in this therapeutic landscape. This article delves into the market dynamics and financial trajectory of ADT, with a particular focus on NILANDRON and similar drugs.

Market Size and Growth

The androgen deprivation therapy market is projected to experience significant growth over the coming years. By 2024, the market is estimated to reach USD 6.10 billion and is expected to grow at a CAGR of 5.80% to reach USD 8.10 billion by 2029[4].

Key Drivers of Market Growth

Several factors are driving the growth of the ADT market:

Rising Burden of Prostate Cancer

Prostate cancer is becoming increasingly prevalent, especially among older men. For instance, the American Cancer Society estimates that in the United States in 2024, about 299,010 new cases of prostate cancer are expected to be reported[4].

Advancements in Treatment Technology

Advancements in treatment technology, such as the development of new androgen receptor inhibitors, are enhancing the efficacy of ADT. For example, the FDA approval of Relugolix (Orgovyx) for treating adults with prostate cancer has been a significant milestone, as it is more effective at reducing testosterone levels compared to traditional treatments like leuprolide (Lupron)[1].

Strategic Initiatives by Market Players

Partnerships, distribution agreements, mergers, and acquisitions are common strategies adopted by key market players to expand their market reach. The exclusive license agreement between Myovant Sciences and Accord Healthcare Ltd for the commercialization of Relugolix (Orgovyx) in various regions is a prime example of such strategic initiatives[1][4].

Regulatory Approvals

Achieving milestones in the drug development cycle, such as the FDA's acceptance of supplemental New Drug Applications (NDAs) and Priority Reviews, also fuels market growth. For instance, the approval of darolutamide (Nubeqa) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has been a significant development[4].

Regional Market Dynamics

North America

North America, particularly the United States, is expected to hold a significant share of the ADT market. The high incidence of prostate cancer in this region, coupled with a growing geriatric population and several product launches, drives the demand for ADT therapeutics[1][4].

Asia-Pacific

The Asia-Pacific region is also a major market for ADT, driven by a large patient population and increasing healthcare expenditures. This region is expected to be the largest market for ADT during the forecast period[4].

Financial Trajectory of ADT Drugs

Revenue Projections

The revenue generated by ADT drugs is expected to increase significantly. For example, the global market for breakthrough therapy drugs, which includes ADT, was valued at $133.3 billion in 2023 and is expected to grow to $287.5 billion by 2029 at a CAGR of 13.8%[3].

Impact of Strategic Partnerships

Strategic partnerships and licensing agreements significantly impact the financial trajectory of ADT drugs. These agreements not only expand the geographical reach of the drugs but also enhance their market penetration. For instance, the partnership between Myovant Sciences and Accord Healthcare Ltd for Relugolix (Orgovyx) is expected to boost market growth by increasing the drug's accessibility across various regions[1][4].

Regulatory and Approval Costs

The cost associated with achieving regulatory approvals and milestones in the drug development cycle is substantial. However, these costs are often offset by the significant revenue generated once the drug is approved and commercialized. For example, the FDA's Priority Review for darolutamide in combination with docetaxel is expected to accelerate its market entry and revenue generation[4].

NILANDRON: A Specific Example

NILANDRON (nilutamide) is an anti-androgen drug used in the treatment of prostate cancer. Here are some key points related to NILANDRON:

Mechanism of Action

NILANDRON works by blocking the action of androgens (male hormones) such as testosterone, which are involved in the growth and spread of prostate cancer cells.

Market Position

While NILANDRON is not as recently highlighted as some newer drugs like Relugolix or darolutamide, it remains a part of the broader ADT market. Its market position is influenced by the overall dynamics of the ADT market, including the rising burden of prostate cancer and advancements in treatment technology.

Financial Impact

The financial impact of NILANDRON is tied to the overall growth of the ADT market. As the market expands due to increasing demand and technological advancements, drugs like NILANDRON benefit from this growth. However, the market share of NILANDRON may be affected by the introduction of newer, more effective treatments.

Challenges and Limitations

Despite the growth potential, the ADT market faces several challenges:

Limited Reimbursement Policies

Limited reimbursement policies can hinder market growth by reducing the affordability of these treatments for patients.

Increasing Side Effects

The increasing side effects associated with long-term use of ADT drugs can also impact market growth negatively[4].

Future Outlook

The future outlook for the ADT market, including drugs like NILANDRON, is positive but with some caveats:

Innovation and Technological Advancements

The continuous innovation in treatment technologies and the use of new technologies like AI in drug development are expected to drive market growth. These advancements will help in developing more effective and safer treatments, which will further boost the market[5].

Regulatory Environment

The regulatory environment, including the impact of laws like the US Inflation Reduction Act, will also influence the market. While these laws may impose price caps and other restrictions, they are also expected to drive innovation and efficiency in drug development[5].

Key Takeaways

  • The ADT market is expected to grow significantly, driven by the rising burden of prostate cancer and advancements in treatment technology.
  • Strategic partnerships and regulatory approvals are key drivers of market growth.
  • North America and the Asia-Pacific region are significant markets for ADT.
  • Drugs like NILANDRON benefit from the overall growth of the ADT market but face challenges such as limited reimbursement policies and increasing side effects.
  • The future outlook is positive, with a focus on innovation and technological advancements.

FAQs

What are the primary drivers of the androgen deprivation therapy market?

The primary drivers include the rising burden of prostate cancer, advancements in treatment technology, strategic initiatives by market players, and regulatory approvals.

How does the US Inflation Reduction Act impact the pharmaceutical sector?

The act imposes price caps and restrictions but is also expected to drive innovation and efficiency in drug development, particularly through the use of new technologies like AI.

What is the expected market size of the ADT market by 2029?

The ADT market is expected to reach USD 8.10 billion by 2029, growing at a CAGR of 5.80% from 2024 to 2029[4].

Which regions are expected to be the largest markets for ADT?

North America, particularly the United States, and the Asia-Pacific region are expected to be significant markets for ADT[1][4].

How do strategic partnerships impact the ADT market?

Strategic partnerships, such as licensing agreements and distribution deals, expand the geographical reach and market penetration of ADT drugs, contributing to market growth[1][4].

Sources

  1. Research and Markets: Androgen Deprivation Therapy - Market Share Analysis, Industry Trends, and Forecast.
  2. BSE Listing Centre: AMI Organics Limited - DRHP.
  3. BCC Research: Global Breakthrough Therapies Market Size and Growth Forecast.
  4. Mordor Intelligence: Androgen Deprivation Therapy Market Size & Share Analysis.
  5. LGT: US Inflation Reduction Act's impact on pharma.

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