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Last Updated: December 22, 2024

CLARAVIS Drug Patent Profile


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

Claravis is a drug marketed by Teva Pharms Usa and is included in two NDAs.

The generic ingredient in CLARAVIS 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 Claravis

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

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SponsorPhase
Children's Oncology GroupPhase 2
Children's Oncology GroupN/A
National Cancer Institute (NCI)N/A

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Pharmacology for CLARAVIS
Drug ClassRetinoid

US Patents and Regulatory Information for CLARAVIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076356-001 Apr 11, 2003 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076135-001 Apr 11, 2003 AB1 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076135-002 Apr 11, 2003 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

CLARAVIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Claravis

Introduction

Claravis, known generically as isotretinoin, is a powerful anti-acne medication that has been a cornerstone in the treatment of severe acne. Despite its effectiveness, the drug has faced significant challenges and controversies, particularly related to its side effects and legal battles. Here, we will delve into the market dynamics and financial trajectory of Claravis.

Historical Context of Claravis

Claravis was initially developed by Hoffmann-La Roche and introduced in the 1980s as a treatment for severe acne. It was marketed under several brand names, including Accutane, Amnesteem, Claravis, and Sotret. The drug quickly gained popularity due to its high efficacy in treating severe acne cases[3].

Market Size and Growth

The global acne drugs market, which includes Claravis, was valued at USD 9.22 billion in 2023 and is projected to grow at a CAGR of 5.2% from 2024 to 2030. This growth is driven by the increasing prevalence of acne, lifestyle changes, rising skin awareness, and growing cosmetic concerns[1].

Distribution Channels

The distribution of Claravis and other acne drugs is evolving, with online pharmacies expected to register the fastest CAGR of 6.6% during the forecast period. This growth is attributed to the COVID-19 pandemic, increased internet connectivity, and a rise in consumer awareness of skin issues. Companies like Patel's Chemist Limited's Click2Pharmacy, PharmEasy, and Tata 1mg are key players in this segment[1].

Regional Market Dynamics

  • North America: This region dominated the acne drugs market in 2023, driven by the high prevalence of acne, developed healthcare infrastructure, and the strong presence of companies involved in the acne drugs market. For instance, Sun Pharmaceutical Industries Ltd. received approval from Health Canada for WINLEVI, a topical drug for acne, in June 2023[1].
  • Europe: Europe accounted for a significant market share in 2023, with factors such as altered lifestyle, rise in stress levels, and hormonal imbalances contributing to the high demand for acne treatments. Companies like Cosmo Pharmaceuticals are involved in partnerships to commercialize acne drugs in European countries[1].
  • Asia Pacific: This region is estimated to register the fastest CAGR over the forecast period, driven by high acne prevalence among adolescents and collaborations among companies to launch new skin treatment drugs[1].

Legal and Regulatory Challenges

Claravis, under its brand name Accutane, has faced significant legal challenges due to its side effects. The drug was withdrawn from the U.S. market in 2010 by Roche, citing financial concerns and the mounting cost of defending lawsuits. Despite its effectiveness, Accutane was linked to severe gastrointestinal problems, including inflammatory bowel disease (IBD) and ulcerative colitis. Numerous lawsuits were filed, with some resulting in large verdicts against Hoffmann-La Roche, although many were later reduced or overturned on appeal[3].

Financial Impact of Legal Battles

The legal battles surrounding Accutane have had a substantial financial impact on its manufacturer. Roche faced multiple large verdicts, including a $25 million verdict in a case where the plaintiff developed inflammatory bowel disease after undergoing Accutane treatment. Although some of these verdicts were later overturned, the cumulative effect of these lawsuits contributed to the drug's withdrawal from the U.S. market[3].

Current Market Status

Despite the withdrawal of Accutane from the U.S. market, isotretinoin remains available under other brand names internationally. The drug continues to be prescribed for severe acne cases, and its market presence is maintained through various generic and branded versions.

Future Outlook

The future outlook for Claravis and similar acne drugs is promising, given the growing demand for effective acne treatments. Innovations in distribution channels, such as online pharmacies, and collaborations among pharmaceutical companies are expected to drive market growth. However, the industry must also address the ongoing concerns about side effects and ensure robust safety protocols and clear labeling to mitigate legal and regulatory risks.

Key Players and Innovations

Companies like Sun Pharmaceutical Industries Ltd., Cosmo Pharmaceuticals, and Hyphens Pharma International Limited are actively involved in the development and commercialization of new acne drugs. These innovations, along with strategic partnerships and distribution agreements, are expected to drive the growth of the acne drugs market[1].

Consumer Awareness and Lifestyle Changes

The increasing awareness of skin health and the rise in cosmetic concerns are driving the demand for acne treatments. Lifestyle changes, including dietary habits and stress levels, are also contributing factors to the growing prevalence of acne, which in turn fuels the market for drugs like Claravis[1].

Telemedicine and Online Pharmacies

The COVID-19 pandemic has accelerated the adoption of telemedicine and online pharmacies, which has positively impacted the acne drugs market. This shift has made it easier for consumers to access medications, including Claravis, contributing to the market's growth[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Claravis. Approvals from health authorities, such as Health Canada's approval of WINLEVI, are essential for the commercial success of these drugs. Companies must navigate these regulatory landscapes carefully to ensure compliance and market access[1].

Financial Trajectory

The financial trajectory of Claravis is influenced by several factors, including market demand, competition, and regulatory compliance. While the drug has faced significant financial challenges due to legal battles, the overall acne drugs market is expected to grow steadily. The shift towards online pharmacies and the increasing prevalence of acne are positive indicators for the financial health of companies involved in this market[1].

Conclusion

The market dynamics and financial trajectory of Claravis are complex and multifaceted. Despite the challenges posed by legal battles and side effects, the drug remains a significant player in the acne treatment market. The growing demand for effective acne treatments, innovations in distribution channels, and strategic collaborations among pharmaceutical companies are expected to drive the market forward.

Key Takeaways

  • The global acne drugs market is projected to grow at a CAGR of 5.2% from 2024 to 2030.
  • Online pharmacies are expected to register the fastest CAGR of 6.6% during the forecast period.
  • North America, Europe, and Asia Pacific are key regions driving the market growth.
  • Legal battles and side effects have significantly impacted the financial trajectory of Claravis.
  • Innovations and strategic partnerships are crucial for market growth.

FAQs

Q: What is the current market size of the global acne drugs market? A: The global acne drugs market was valued at USD 9.22 billion in 2023[1].

Q: Why was Accutane withdrawn from the U.S. market? A: Accutane was withdrawn from the U.S. market due to financial concerns and the mounting cost of defending lawsuits related to its side effects[3].

Q: Which regions are driving the growth of the acne drugs market? A: North America, Europe, and Asia Pacific are the key regions driving the growth of the acne drugs market[1].

Q: How has the COVID-19 pandemic impacted the acne drugs market? A: The COVID-19 pandemic has accelerated the adoption of telemedicine and online pharmacies, positively impacting the acne drugs market[1].

Q: What are the main factors driving the demand for acne treatments? A: The increasing prevalence of acne, lifestyle changes, rising skin awareness, and growing cosmetic concerns are driving the demand for acne treatments[1].

Sources

  1. Grand View Research - Acne Drugs Market Size, Share And Trends Report, 2030
  2. Claranova - Analystes financiers Archive
  3. Miller and Zois - Accutane Lawsuits: The Story with a 2024 Update
  4. Clarivate - A Look at PBM Drug Spending: Trend Fueled by Specialty Drug Growth
  5. CLARA Analytics - CLARA Analytics Achieves Record Revenue Growth, Accelerates Innovation

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