Clobetasol propionate - Generic Drug Details

What are the generic sources for clobetasol propionate and what is the scope of patent protection?

Clobetasol propionate is the generic ingredient in twelve branded drugs marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Norvium Bioscience, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Beach Prods, Fougera Pharms, Hikma, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Galderma Labs Lp, Mylan, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, and Eyenovia, and is included in ninety-eight NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has seventy-one patent family members in twenty-five countries.

There are eleven drug master file entries for clobetasol propionate. Forty-one suppliers are listed for this compound.

Summary for clobetasol propionate

International Patents:	71
US Patents:	8
Tradenames:	12
Applicants:	41
NDAs:	98
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	69
Patent Applications:	5,812
Drug Prices:	Drug price trends for clobetasol propionate
Drug Sales Revenues:	Drug sales revenues for clobetasol propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clobetasol propionate
What excipients (inactive ingredients) are in clobetasol propionate?	clobetasol propionate excipients list
DailyMed Link:	clobetasol propionate at DailyMed

See drug prices for clobetasol propionate

See drug sales revenues for clobetasol propionate

Recent Clinical Trials for clobetasol propionate

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

Sponsor	Phase
Kantonsspital Winterthur KSW	N/A
Dermatology Consulting Services, PLLC	Phase 4
October 6 University	Phase 3

See all clobetasol propionate clinical trials

Pharmacology for clobetasol propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for clobetasol propionate

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for clobetasol propionate

D07AD	Corticosteroids, very potent (group IV)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMPOYZ	Cream	clobetasol propionate	0.025%	209483	1	2019-12-06
OLUX E	Emulsion Foam	clobetasol propionate	0.05%	022013	1	2010-02-25
CLOBEX	Spray	clobetasol propionate	0.05%	021835	1	2008-09-29
CLOBEX	Topical Shampoo	clobetasol propionate	0.05%	021644	1	2008-01-09
CLOBEX	Lotion	clobetasol propionate	0.05%	021535	1	2006-03-27
OLUX	Topical Foam	clobetasol propionate	0.05%	021142	1	2005-06-27

US Patents and Regulatory Information for clobetasol propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	AEROSOL, FOAM;TOPICAL	208779-001	Oct 4, 2018	AB1	RX	No	Yes
Quagen	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	211240-001	Feb 17, 2022	AT	RX	No	No
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	074249-001	Jul 8, 1996	AB1	RX	No	No
Fougera Pharms	TEMOVATE	clobetasol propionate	GEL;TOPICAL	020337-001	Apr 29, 1994		DISCN	Yes	No
Epic Pharma Llc	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	211348-001	Oct 26, 2018		DISCN	No	No

Expired US Patents for clobetasol propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	7,700,081
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	5,972,920
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	7,316,810
Norvium Bioscience	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	6,126,920
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	5,990,100

International Patents for clobetasol propionate

Country	Patent Number	Title	Estimated Expiration
Japan	5833007
European Patent Office	2438910	Procédé et compositions de micro-émulsion et d'émulsion submicronique (Microemulsion & sub-micron emulsion process & compositions)
Hungary	E061418
Taiwan	201701882	Aqueous suspension containing nano particles of GLUCOCORTICOIDS
Canada	2985171	AGENT AQUEUX DE SUSPENSION COMPRENANT DES NANOPARTICULES DE GLUCOCORTICOSTEROIDE (AQUEOUS SUSPENSION CONTAINING NANOPARTICLES OF GLUCOCORTICOSTEROID)

Clobetasol propionate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clobetasol Propionate

Introduction to Clobetasol Propionate

Clobetasol propionate is a potent corticosteroid used to treat various skin conditions, including eczema, psoriasis, and contact dermatitis, as well as post-operative inflammation and pain following ocular surgery. Its market dynamics are influenced by several key factors, including clinical efficacy, regulatory approvals, market competition, and patient needs.

Clinical Efficacy and Regulatory Approvals

The recent FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain following ocular surgery marks a significant milestone. Clinical studies have shown that this formulation provides rapid and sustained clearance of inflammation and pain relief, with approximately 80% of patients experiencing complete relief from pain as soon as four days post-surgery, compared to 50% for the vehicle group[2][3].

Market Size and Growth

The global clobetasol propionate market is projected to witness substantial growth, with a Compound Annual Growth Rate (CAGR) of 4.8% from 2023 to 2030. This growth is driven by increasing demand for effective treatments for skin conditions and post-operative care in ocular surgery[4].

Key Market Segments

• By Application: The market is segmented into psoriasis, eczema, dermatitis, and other skin conditions. The ophthalmic segment, particularly for post-operative care, is emerging as a significant contributor to market growth[4].
• By Formulation: Clobetasol propionate is available in various forms, including creams, ointments, solutions, and shampoos. The ophthalmic suspension is the latest addition, offering a convenient dosing regimen without the need for tapering[3].
• By Distribution Channel: The market is distributed through retail pharmacies, hospital pharmacies, and online pharmacies. The strategic partnership between Formosa Pharmaceuticals and Eyenovia for U.S. commercialization is expected to enhance market reach and penetration[3].

Competitive Landscape

The clobetasol propionate market is highly competitive, with major players such as GlaxoSmithKline plc, Mylan N.V., Pfizer Inc, Zydus Cadila, LEO Pharma A/S, and others. The entry of new players like Formosa Pharmaceuticals and AimMax Therapeutics, with their proprietary APNT™ nanoparticle formulation platform, is expected to disrupt the market and capture significant market share[4].

Regional Analysis

The market is geographically segmented into North America, South America, Asia-Pacific, Europe, and the Rest of the World. The ophthalmic steroid market in the United States alone serves a substantial patient population, with an estimated seven million ocular surgeries performed annually, providing a lucrative market opportunity[3].

Technological Advancements

The proprietary APNT™ nanoparticle formulation platform used in the new ophthalmic suspension represents a technological advantage, offering enhanced delivery and efficacy. This platform could set a new standard of care in post-operative inflammation and pain management, influencing market dynamics and prescribing habits[3].

Financial Trajectory

The financial trajectory of clobetasol propionate is promising, driven by its strong clinical outcomes and favorable market conditions. Here are some key financial indicators:

• Market Size: The global clobetasol propionate market is expected to grow significantly, with a projected CAGR of 4.8% from 2023 to 2030[4].
• Revenue Growth: The ophthalmic steroid market, valued at $1.3 billion, is expected to see rapid adoption and market penetration of the new clobetasol propionate ophthalmic suspension, contributing to revenue growth[3].
• Cost and Pricing: The product's availability at a low fixed price, regardless of insurance status, is seen as a positive factor by ophthalmic surgeons, potentially reducing managed care hurdles and increasing patient access[2].

Challenges and Opportunities

• Managed Care Hurdles: Despite the positive market outlook, managed care hurdles remain a significant issue, with 53% of ophthalmic surgeons citing this as a major challenge. However, the fixed pricing strategy of the new product aims to mitigate this issue[2].
• Regulatory Environment: The FDA approval process is crucial for market entry. Recent approvals have paved the way for new entrants, but ongoing regulatory compliance is essential for sustained market presence[3].

Consumer Behavior and Adherence

The ease of use and elimination of a tapering schedule for the new ophthalmic suspension are expected to improve patient adherence and recovery outcomes. This aligns with consumer preferences for convenient and effective treatments, further driving market growth[3].

Key Takeaways

• Strong Clinical Efficacy: Clobetasol propionate ophthalmic suspension 0.05% has demonstrated superior clinical outcomes, including rapid pain relief and inflammation clearance.
• Market Growth: The global market is projected to grow at a CAGR of 4.8% from 2023 to 2030.
• Technological Advancements: The proprietary APNT™ nanoparticle formulation platform offers enhanced delivery and efficacy.
• Competitive Landscape: New entrants like Formosa Pharmaceuticals and AimMax Therapeutics are expected to disrupt the market.
• Financial Trajectory: The market is valued at $1.3 billion, with significant revenue growth anticipated due to rapid adoption of the new ophthalmic suspension.

FAQs

Q: What is the FDA-approved product for post-operative inflammation and pain following ocular surgery by Formosa Pharmaceuticals and AimMax Therapeutics? A: The FDA-approved product is clobetasol propionate ophthalmic suspension 0.05%[3].

Q: What is the unique feature of clobetasol propionate ophthalmic suspension 0.05%? A: The unique feature is its proprietary APNT™ nanoparticle formulation platform, which offers enhanced delivery and efficacy without the need for tapering[3].

Q: How does clobetasol propionate ophthalmic suspension 0.05% stand out in the market? A: It stands out due to its rapid and sustained clearance of inflammation and pain relief, with approximately 80% of patients experiencing complete relief from pain as soon as four days post-surgery[2][3].

Q: What were the results of the Phase 3 clinical trials for clobetasol propionate ophthalmic suspension 0.05%? A: The Phase 3 trials showed statistically significant results, with rapid pain relief and inflammation clearance, and no single adverse event affecting more than 2% of patients[2][3].

Q: What is the estimated market size and growth rate of the global clobetasol propionate market? A: The global market is estimated to grow at a CAGR of 4.8% from 2023 to 2030, with the ophthalmic steroid market valued at $1.3 billion[3][4].

Citations

1. Cognitivemarketresearch.com: Clobetasol Propionate Market Report 2024 (Global Edition)
2. Eyenovia.com: Eyenovia Announces Launch and Commercial Availability of Clobetasol Propionate Ophthalmic Suspension 0.05%
3. Stocktitan.net: Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%
4. Openpr.com: Clobetasol Propionate Market to Witness Stunning Growth with 4.8% CAGR[4].