TOPICORT Drug Patent Profile

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

Topicort is a drug marketed by Taro and is included in ten NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Topicort

A generic version of TOPICORT was approved as desoximetasone by PADAGIS ISRAEL on July 1^st, 2003.

Summary for TOPICORT

International Patents:	4
US Patents:	2
Applicants:	1
NDAs:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	4
Patent Applications:	4,920
Drug Prices:	Drug price information for TOPICORT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOPICORT
What excipients (inactive ingredients) are in TOPICORT?	TOPICORT excipients list
DailyMed Link:	TOPICORT at DailyMed

See drug prices for TOPICORT

See drug sales revenues for TOPICORT

Recent Clinical Trials for TOPICORT

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Psoriasis Treatment Center of Central New Jersey	Phase 4
Taro Pharmaceuticals USA	Phase 4

See all TOPICORT clinical trials

Pharmacology for TOPICORT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for TOPICORT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOPICORT	Topical Spray	desoximetasone	0.25%	204141	1	2013-12-18

US Patents and Regulatory Information for TOPICORT

TOPICORT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	073210-001	Nov 30, 1990	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	074286-001	Jun 7, 1996		DISCN	No	No
Taro	TOPICORT	desoximetasone	GEL;TOPICAL	074904-001	Jul 14, 1998	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018763-001	Sep 30, 1983		DISCN	Yes	No
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	073193-001	Nov 30, 1990	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	017856-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018594-001	Jan 17, 1985	AB	RX	Yes	Yes

Expired US Patents for TOPICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro	TOPICORT	desoximetasone	SPRAY;TOPICAL	204141-001	Apr 11, 2013	5,990,100

International Patents for TOPICORT

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

Country	Patent Number	Title	Estimated Expiration
Israel	187666	הרכב נוזלי ויציב של דסוקסימטאסון ואיזופרופיל מיריסטט עם רמת זיהומים מחומצנים פחותה במהלך איחסון ארוך טווח (Stable liquid formulation comprising desoximetasone and isopropyl myristate with reduced oxidized impurity during long-term storage)
Canada	2609579	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (STABLE LIQUID DESOXIMETASONE COMPOSITIONS WITH REDUCED OXIDIZED IMPURITY)
European Patent Office	1888026	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (A STABLE LIQUID FORMULATION COMPRISING DESOXIMETASONE AND ISOPROPYL MYRISTATE WITH REDUCED OXIDIZED IMPURITY DURING LONG-TERM STORAGE)
World Intellectual Property Organization (WIPO)	2006130510

TOPICORT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOPICORT

Introduction to TOPICORT

TOPICORT, a synthetic corticosteroid, is marketed by Taro Pharmaceuticals U.S.A., Inc. in various topical dosage forms, including cream, ointment, gel, and spray. It is primarily used for the treatment of plaque psoriasis and other skin conditions.

Market Context of Topical Drugs

The global topical drugs market, which includes products like TOPICORT, is experiencing significant growth driven by several key factors.

• Rising Prevalence of Skin Conditions: The increasing incidence of skin disorders such as acne, eczema, and psoriasis globally is a major driver. For instance, skin issues affect approximately 50 million individuals in the U.S. annually, and in India, 41.7 per 1,000 people suffer from skin complaints[3].
• Aging Population and Chronic Diseases: The aging population and the growing prevalence of chronic diseases are also contributing to the market growth. Consumer preference for non-invasive treatments and widespread skin infections further boost the demand for topical drugs[4].

Market Size and Growth Projections

The global topical drug delivery market, which encompasses products like TOPICORT, is projected to see substantial growth.

• Current Market Size: As of 2022, the global topical drug delivery market was estimated to be worth $207.4 billion[1].
• Future Projections: This market is expected to reach $317.8 billion by 2027, growing at a CAGR of 8.9% from 2022 to 2027. Another report indicates that the market will grow from $152.77 billion in 2023 to $168.19 billion in 2024 at a CAGR of 10.1%, and further to $252.48 billion by 2028 at a CAGR of 10.7%[1][4].

Drivers of Market Growth

Several factors are driving the growth of the topical drug delivery market, which directly impacts the financial trajectory of products like TOPICORT.

• High Incidence of Burn Injuries: The high incidence of burn injuries is a significant driver, as topical treatments are often the first line of treatment for such injuries[1].
• Increasing Number of Smokers: Smoking is linked to various skin conditions, and the increasing number of smokers worldwide contributes to the demand for topical treatments[1].
• Growing Prevalence of Diabetes: Diabetes often leads to skin conditions that require topical treatments, further driving the market[1].
• Advancements in Transdermal Drug Delivery Systems: Innovations in transdermal patches and other formulations are enhancing the efficacy and convenience of topical drugs, attracting more consumers[4].

Restraints and Challenges

While the market is growing, there are also some restraints and challenges that could impact the financial trajectory of TOPICORT.

• Continuous Irritation and Allergies: Some topical drugs, including corticosteroids like TOPICORT, can cause continuous irritation on the skin and allergies, which can limit their use[1].
• Regulatory Hurdles: Regulatory requirements, such as those related to pediatric use, can also pose challenges. For example, the FDA has recommended against expanding the indication of TOPICORT Topical Spray to the pediatric population due to the high incidence of HPA axis suppression observed in clinical trials[5].

Regional Market Dynamics

The growth of the topical drugs market varies by region, with some areas showing more promising prospects than others.

• Asia Pacific: This region is expected to register the fastest CAGR of 7.2% over the forecast period, driven by rising healthcare expenditures, higher prevalence of skin disorders, and enhanced awareness of dermatological health. India, in particular, is expected to see significant growth due to its vast population suffering from skin diseases and improving healthcare accessibility[3].

Financial Impact on TOPICORT

Given the overall market trends and drivers, TOPICORT is likely to benefit from the growing demand for topical treatments.

• Revenue Potential: As part of the broader topical drug delivery market, TOPICORT stands to gain from the projected market growth. With the market expected to reach $317.8 billion by 2027, products like TOPICORT will likely see increased revenue[1].
• Competitive Advantage: Innovations in formulations and delivery systems, such as the topical spray form of TOPICORT, can provide a competitive edge in the market. This can help in capturing a larger market share and enhancing financial performance[5].

Key Takeaways

• The global topical drug delivery market is growing rapidly, driven by factors such as the high incidence of skin conditions, burn injuries, and chronic diseases.
• TOPICORT, as a part of this market, benefits from these drivers but also faces challenges like skin irritation and regulatory hurdles.
• Regional markets, especially in the Asia Pacific, offer significant growth opportunities.
• Innovations in formulations and delivery systems are crucial for maintaining a competitive edge.

FAQs

1. What is the current market size of the global topical drug delivery market?

   • The global topical drug delivery market was estimated to be worth $207.4 billion in 2022[1].

2. What is the projected growth rate of the global topical drug delivery market?

   • The market is expected to grow at a CAGR of 8.9% from 2022 to 2027[1].

3. What are the main drivers of the topical drug delivery market?

   • High incidence of burn injuries, increasing number of smokers, growing prevalence of diabetes, and advancements in transdermal drug delivery systems are key drivers[1].

4. What are some challenges faced by topical drugs like TOPICORT?

   • Continuous irritation on the skin and allergies caused by topical drugs, as well as regulatory hurdles, are significant challenges[1][5].

5. Which region is expected to see the fastest growth in the topical drugs market?

   • The Asia Pacific region is expected to register the fastest CAGR of 7.2% over the forecast period[3].

Sources

1. MarketsandMarkets: Topical Drug Delivery Market Growth, Drivers, and Opportunities
2. CT.gov: Prescription Drug Reimportation in Connecticut
3. Grand View Research: Topical Drugs Market Size And Share | Industry Report, 2030
4. The Business Research Company: Global Topical Drug Delivery Market Report 2024
5. FDA: Clinical Review and Evaluation: TOPICORT (Desoximetasone)