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Last Updated: December 26, 2024

TRETINOIN MICROSPHERE Drug Patent Profile


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

Tretinoin Microsphere is a drug marketed by Encube and is included in one NDA.

The generic ingredient in TRETINOIN MICROSPHERE is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tretinoin Microsphere

A generic version of TRETINOIN MICROSPHERE was approved as tretinoin by PADAGIS US on December 24th, 1998.

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Drug patent expirations by year for TRETINOIN MICROSPHERE
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Recent Clinical Trials for TRETINOIN MICROSPHERE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Taro Pharmaceuticals USAEarly Phase 1
Galderma Laboratories, L.P.Phase 4
Spear PharmaceuticalsPhase 3

See all TRETINOIN MICROSPHERE clinical trials

Pharmacology for TRETINOIN MICROSPHERE
Drug ClassRetinoid

US Patents and Regulatory Information for TRETINOIN MICROSPHERE

TRETINOIN MICROSPHERE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Encube TRETINOIN MICROSPHERE tretinoin GEL;TOPICAL 215609-001 Aug 22, 2023 AB 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

TRETINOIN MICROSPHERE Market Analysis and Financial Projection Experimental

Tretinoin Microsphere: Market Dynamics and Financial Trajectory

Introduction

Tretinoin, a derivative of vitamin A, is a widely used drug in the dermatology sector, particularly for its anti-aging and skin-renewing properties. The tretinoin microsphere formulation, such as tretinoin microsphere gel (TMG), has gained significant attention for its efficacy in treating photodamaged skin and various dermatological conditions. Here, we delve into the market dynamics and financial trajectory of tretinoin microsphere products.

Market Size and Forecast

The global tretinoin market, which includes tretinoin microsphere formulations, is projected to experience substantial growth. As of 2024, the tretinoin market was valued at USD 2.5 billion and is expected to reach USD 7.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.1% during the forecast period[1].

Drivers of Market Growth

Several factors are driving the growth of the tretinoin microsphere market:

Expansion of the Beauty and Cosmetics Sector

The increasing focus on skincare and anti-aging products within the beauty and cosmetics industry is a significant driver. Tretinoin's skin-renewing properties make it a popular ingredient in skincare formulations[1].

Prescription Demand

Tretinoin is often prescribed for specific dermatological conditions, and the demand for effective, scientifically validated therapies drives the prescription market. Dermatologists frequently recommend tretinoin, which increases consumer awareness and demand[1].

Clinical Development and Research

Ongoing research and development in dermatology and skincare are leading to innovations in tretinoin formulations. The creation of new products and formulations contributes to market expansion[1].

Patient Preference for Topical Treatments

Patients often prefer topical treatments for dermatological issues, and tretinoin microsphere gel, being a topical formulation, benefits from this preference[1].

Influence of Social Media and Beauty Influencers

Social media platforms and beauty influencers play a crucial role in promoting skincare trends, including products containing tretinoin. This influencer marketing can increase consumer interest and demand[1].

Distribution Channels

Tretinoin microsphere products are available through various distribution channels:

Pharmacies and Drugstores

Over-the-counter tretinoin products, including microsphere formulations, are commonly found in pharmacies and drugstores[1].

Prescription Dispensing

Stronger formulations of tretinoin, particularly those for specific dermatological conditions, are dispensed through prescriptions by healthcare professionals[1].

Online Retail

The growing trend of online retail includes the availability of tretinoin-containing products through e-commerce platforms, making them more accessible to consumers[1].

Geographic Market Trends

North America

North America, particularly the United States and Canada, is a significant market for tretinoin. The high prevalence of acne vulgaris in the U.S. contributes to the demand for tretinoin products[4].

Europe

Europe is another major market, with a strong presence of dermatological treatments and a high demand for skincare products[4].

Asia-Pacific

The Asia-Pacific region, especially Japan, presents a substantial market opportunity due to the presence of companies like Chugai, which has released tretinoin products for treating leukemia[4].

Middle East and Africa, Latin America

These regions also show potential for growth, although they currently represent smaller market shares compared to North America and Europe[1].

Clinical Efficacy and Side Effects

Clinical Efficacy

Studies have shown that tretinoin microsphere gel is effective in treating photodamaged skin. A 6-month randomized, double-blind study demonstrated significant improvements in the overall severity of photodamage compared to a placebo group[5].

Side Effects

While tretinoin microsphere gel is generally well-tolerated, it can cause side effects such as peeling, dryness, itching, and burning/stinging. These side effects are typically mild and transient[5].

Financial Performance of Key Players

Revenue and Growth Trends

Companies like Sol-Gel Technologies, which focus on dermatology products, are seeing growth in their revenue streams from tretinoin and other related products. For instance, Sol-Gel Technologies reported revenue from the sales of their partnered products, including topical treatments, and are experiencing robust uptake by prescribers[3].

Royalty Streams and Pipeline Development

Sol-Gel Technologies is now realizing a royalty stream from the net sales of their partnered products and is focusing on building out their pipeline and identifying new revenue-generating opportunities in international markets[3].

Challenges and Inhibitors

Side Effects and Adverse Reactions

The associated side effects with tretinoin products, particularly oral formulations used for treating conditions like leukemia, can inhibit market growth. These side effects include leukocytosis, retinoic acid syndrome, thrombosis, liver damage, high lipids, and idiopathic intracranial hypertension[4].

Key Players in the Market

Major Companies

Companies such as Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Glaxosmithkline Inc., Janssen Pharmaceuticals, Inc., Bausch Health Companies Inc., and Ortho Dermatologics are significant players in the global tretinoin market[4].

Market Trends and Future Outlook

Global Skin Health Trends

The increasing global trend towards prioritizing skin health and investing in skincare regimens is driving the demand for effective skincare products like tretinoin microsphere gel[1].

Innovations in Formulations

Continuous innovations in tretinoin formulations, such as the development of microsphere gels, are expected to further drive market growth by offering more effective and tolerable treatments[1].

Key Takeaways

  • The tretinoin market, including microsphere formulations, is projected to grow significantly, driven by the expansion of the beauty and cosmetics sector and the demand for effective dermatological treatments.
  • Tretinoin microsphere gel has shown clinical efficacy in treating photodamaged skin and is preferred by patients due to its topical application.
  • The market is influenced by recommendations from dermatologists, social media trends, and the availability of products through various distribution channels.
  • Despite potential side effects, the overall market trajectory for tretinoin microsphere products remains positive.

FAQs

What is the projected market size of the tretinoin market by 2031?

The tretinoin market is projected to reach USD 7.5 billion by 2031, growing at a CAGR of 10.1% from 2024-2031[1].

What are the primary drivers of the tretinoin microsphere market?

The primary drivers include the expansion of the beauty and cosmetics sector, prescription demand, clinical development and research, patient preference for topical treatments, and the influence of social media and beauty influencers[1].

Which regions are the largest markets for tretinoin?

North America and Europe are the largest markets for tretinoin, with the Asia-Pacific region, particularly Japan, also presenting significant market opportunities[4].

What are the common side effects of tretinoin microsphere gel?

Common side effects include peeling, dryness, itching, and burning/stinging, which are typically mild and transient[5].

Which companies are major players in the global tretinoin market?

Major companies include Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Glaxosmithkline Inc., Janssen Pharmaceuticals, Inc., Bausch Health Companies Inc., and Ortho Dermatologics[4].

Sources

  1. Verified Market Research: Tretinoin Market Size, Share, Scope, Trends And Forecast.
  2. Sol-Gel Technologies: Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update.
  3. GlobeNewswire: Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update.
  4. Fortune Business Insights: Tretinoin Market Size, Industry Share | Forecast 2032.
  5. MDedge: Tretinoin Microsphere Gel 0.1% for Photodamaged Facial Skin.

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