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Last Updated: December 22, 2024

MYORISAN Drug Patent Profile


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

Myorisan is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in MYORISAN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Myorisan

A generic version of MYORISAN was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.

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Drug patent expirations by year for MYORISAN
Drug Prices for MYORISAN

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Drug Sales Revenue Trends for MYORISAN

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Recent Clinical Trials for MYORISAN

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SponsorPhase
Children's Oncology GroupPhase 2
National Cancer Institute (NCI)Phase 2
National Cancer Institute (NCI)Phase 1

See all MYORISAN clinical trials

Pharmacology for MYORISAN
Drug ClassRetinoid

US Patents and Regulatory Information for MYORISAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-001 Jan 19, 2012 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-003 Jan 19, 2012 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-002 Jan 19, 2012 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-004 Aug 25, 2015 AB1 RX 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

MYORISAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Isotretinoin Drugs (Including MyorisAN)

Introduction to Isotretinoin Drugs

Isotretinoin, commonly known by brand names such as Accutane, MyorisAN, and others, is a powerful oral retinoid used primarily for the treatment of severe acne, including nodular and conglobate acne. Here, we will delve into the market dynamics and financial trajectory of isotretinoin drugs, including the brand MyorisAN.

Global Market Size and Growth

The global isotretinoin drugs market has been experiencing steady growth. As of 2022, the market size was valued at USD 1,337 million and is projected to reach USD 2,053 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.88% during the forecast period[1][5].

Regional Market Analysis

North America

North America is the largest contributor to the global isotretinoin drugs market, driven by a well-developed healthcare infrastructure, favorable government regulations, and a high prevalence of skin problems such as acne. The region is expected to grow at a CAGR of 5.26% during the forecast period[1].

Europe

Europe is anticipated to grow at a CAGR of 3.84% over the forecast period. The growth in this region is attributed to the rising cases of genetic disorders and skin cancer, along with increasing healthcare spending and awareness of illnesses[1].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for isotretinoin drugs, driven by the emergence of several key players such as Sun Pharma and Dr. Reddy's Laboratories Ltd in India. This region is witnessing high demand for isotretinoin due to increasing awareness and funding from investors[1].

Market Drivers

Increasing Incidence of Severe Acne

The rising prevalence of severe acne, particularly among adolescents and young adults, is a significant driver for the isotretinoin drugs market. Severe acne can lead to substantial physical and emotional distress, increasing the demand for effective treatment options like isotretinoin[5].

Enhanced Awareness and Diagnosis

Improved awareness about skin conditions and advancements in dermatology have led to more people seeking medical treatments for acne. This increased diagnosis and treatment rate boosts the market demand for isotretinoin[5].

Technological Advancements in Drug Formulations

Investments in research and development to enhance the efficacy and safety of isotretinoin formulations are driving market growth. New product launches, such as ABSORICA LD by Sun Pharma, are examples of these advancements[2].

Market Restraints

Generic Competition and Pricing Pressures

The expiration of patents for branded isotretinoin products has led to the entry of generic versions into the market. While this enhances affordability, it also creates intense pricing competition, potentially reducing profit margins for both branded and generic manufacturers[2].

Regulatory and Legal Challenges

Historically, isotretinoin has faced significant legal challenges, particularly with Accutane, which was pulled from the U.S. market in 2010 due to financial concerns and the mounting cost of defending lawsuits related to side effects such as inflammatory bowel disease (IBD) and ulcerative colitis[4].

Competitive Landscape

Key Market Players

Major companies such as Roche, Dr. Reddy's Laboratories, Teva Pharmaceuticals, Sun Pharma, and Almirall are actively investing in research and development to expand their product lines and enhance the efficacy and safety of isotretinoin formulations. These companies are also engaging in strategic activities like mergers, acquisitions, and new product launches to bolster their market positions[2].

Strategic Initiatives

Companies are focusing on mitigating side effects and improving patient adherence through novel formulations and delivery systems. Additionally, there is a trend towards collaborative partnerships between pharmaceutical companies and healthcare providers to streamline distribution channels and enhance patient access to isotretinoin treatments[2].

Financial Impact of Market Trends

Revenue Growth

The isotretinoin drugs market is expected to see strong revenue growth, with the global market size projected to reach USD 2.33 billion by 2032 at a CAGR of 10.6% from 2023 to 2032[2].

Investment in R&D

Significant investments in research and development are driving innovation in the market. These investments are aimed at addressing severe side effects related to isotretinoin use and improving patient outcomes, which in turn contributes to the financial growth of the market[2].

Impact of COVID-19

The COVID-19 pandemic had a temporary impact on the market, leading to lower-than-anticipated demand and supply chain disruptions. However, the market has been recovering, with ongoing research efforts and strategic pricing strategies helping to maintain market competitiveness[2].

Hospital Pharmacies and Distribution

Market Share

Hospital pharmacies hold a substantial market share due to the availability of medical experts such as dermatologists and the accessibility of hospital services. Hospital pharmacies account for 20–25% of hospital revenue and are expected to grow at a CAGR of 4.30% over the forecast period[1].

Key Takeaways

  • The global isotretinoin drugs market is projected to grow significantly, driven by the increasing incidence of severe acne and advancements in dermatology.
  • North America and Europe are key regions, with Asia-Pacific emerging as a fast-growing market.
  • Generic competition and regulatory challenges are significant restraints, but strategic investments in R&D and collaborative partnerships are driving market growth.
  • Hospital pharmacies play a crucial role in the distribution and accessibility of isotretinoin drugs.

FAQs

What is the projected market size of the isotretinoin drugs market by 2031?

The isotretinoin drugs market is projected to reach USD 2,053 million by 2031[1][5].

Which region is the fastest-growing market for isotretinoin drugs?

The Asia-Pacific region is the fastest-growing market for isotretinoin drugs[1].

What are the major drivers of the isotretinoin drugs market?

The major drivers include the increasing incidence of severe acne, enhanced awareness and diagnosis, and technological advancements in drug formulations[5].

How has generic competition affected the isotretinoin market?

Generic competition has led to pricing pressures, reducing profit margins for both branded and generic manufacturers, but it has also enhanced affordability and accessibility of isotretinoin drugs[2].

What are the key strategies adopted by market players to maintain competitiveness?

Key strategies include investments in R&D, new product launches, strategic pricing, and collaborative partnerships to streamline distribution channels and enhance patient access[2].

Sources

  1. Straits Research: Isotretinoin Drugs Market Size, Share, Analysis and Forecast to 2031
  2. Business Research Insights: Isotretinoin Capsule Market Size, Growth, Global Forecast, 2032
  3. The Business Research Company: Global Isotretinoin Drugs Market Report 2024
  4. Miller and Zois: Accutane Lawsuits: The Story with a 2024 Update
  5. Verified Market Research: Isotretinoin Drugs Market Size, Share, Trends, Growth & Forecast

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