FLURANDRENOLIDE - Generic Drug Details

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

Flurandrenolide is the generic ingredient in four branded drugs marketed by Almirall, Chartwell Rx, Alpharma Us Pharms, Padagis Israel, Teligent, and Lilly, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for flurandrenolide. Four suppliers are listed for this compound.

Summary for FLURANDRENOLIDE

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	10
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	6,750
Drug Prices:	Drug price trends for FLURANDRENOLIDE
What excipients (inactive ingredients) are in FLURANDRENOLIDE?	FLURANDRENOLIDE excipients list
DailyMed Link:	FLURANDRENOLIDE at DailyMed

See drug prices for FLURANDRENOLIDE

Pharmacology for FLURANDRENOLIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLURANDRENOLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	CORDRAN	flurandrenolide	LOTION;TOPICAL	013790-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	CORDRAN N	flurandrenolide; neomycin sulfate	OINTMENT;TOPICAL	050345-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alpharma Us Pharms	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	087203-001	Apr 29, 1982		DISCN	No	No

Expired US Patents for FLURANDRENOLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	CORDRAN	flurandrenolide	TAPE;TOPICAL	016455-001	Approved Prior to Jan 1, 1982

FLURANDRENOLIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flurandrenolide

Introduction to Flurandrenolide

Flurandrenolide is a medium-strength topical corticosteroid used to treat various skin conditions such as eczema, dermatitis, allergies, and rashes. It is available in several formulations, including creams, ointments, and a unique polyethylene tape called Cordran[1][4].

Market Overview

The market for topical corticosteroids, including flurandrenolide, is influenced by several factors:

Demand and Usage

Flurandrenolide is prescribed for corticosteroid-responsive dermatoses, which are common skin conditions. The demand for this medication is steady, driven by the prevalence of these conditions. However, the COVID-19 pandemic had a significant impact on the pharmaceutical industry, including a decline in patient visits to physicians and reduced prescribing rates[2].

Competitive Landscape

The market for topical corticosteroids is competitive, with several other medications available. Companies like Teligent, Inc. and Mayne Pharma play significant roles in this market. Teligent, Inc., for example, markets 37 generic topical pharmaceutical products in the United States, including flurandrenolide formulations[3].

Financial Performance

Revenue Trends

The financial performance of companies that manufacture and market flurandrenolide has been impacted by various market dynamics. For instance, Mayne Pharma reported a decline in revenue in the fiscal year 2020, partly due to the COVID-19 pandemic. Their Specialty Brands Division, which includes dermatology products like flurandrenolide, saw a 14% decline in sales compared to the previous year[2].

Teligent, Inc.'s Financials

Teligent, Inc., another key player, experienced mixed results. While they expanded their manufacturing capabilities and received FDA approvals for several generic topical products, they faced significant financial and operating challenges. The company's revenue from generic topical products was affected by competition and delays in FDA approvals[3].

Impact of COVID-19

The COVID-19 pandemic had a profound impact on the pharmaceutical industry, including the market for flurandrenolide:

Reduced Prescribing Rates

Physician office closures and reduced patient visits led to a decline in prescribing rates for dermatology products, including flurandrenolide. Mayne Pharma reported a 15% decline in prescriptions for their dermatology portfolio during April and May 2020[2].

Supply Chain and Manufacturing

Despite the challenges, companies like Mayne Pharma and Teligent, Inc. maintained operational capabilities. Mayne Pharma's Greenville facility, for example, produced record volumes in 2020, and Teligent, Inc. continued to expand their manufacturing facilities to support future growth[2][3].

Cost Base and Operational Efficiency

To mitigate the impact of declining revenues, companies have focused on optimizing their cost base:

Mayne Pharma's Cost Reduction

Mayne Pharma achieved significant cost reductions, including a $16 million decrease in operating expenses and a $15 million decrease in gross R&D spend. They also restructured their dermatology sales team, which is expected to deliver annualized operating expense savings of $12 million[2].

Teligent, Inc.'s Strategic Adjustments

Teligent, Inc. has also been reexamining their strategy to bolster their business. They have placed additional emphasis on their private label and contract development and manufacturing businesses to diversify their revenue streams[3].

Future Outlook

Market Growth Potential

Despite current challenges, the market for topical corticosteroids like flurandrenolide has growth potential. Teligent, Inc. estimates that the addressable market for their pending FDA filings, including topical products, totals over $140 million per annum[3].

Expansion and Diversification

Companies are exploring new opportunities to expand their product portfolios and capabilities. Teligent, Inc. is focusing on developing and marketing a broader range of generic pharmaceutical products, including high-barrier dosage forms, to leverage their existing expertise and broaden their platform for strategic growth[3].

Key Takeaways

• Market Demand: Steady demand driven by common skin conditions, but impacted by COVID-19.
• Financial Performance: Decline in revenue due to reduced prescribing rates and competition.
• Operational Efficiency: Companies focusing on cost reductions and strategic adjustments.
• Future Outlook: Growth potential in the market for topical corticosteroids, with companies diversifying their product portfolios.

FAQs

Q: What is flurandrenolide used for? A: Flurandrenolide is used to treat various skin conditions such as eczema, dermatitis, allergies, and rashes by reducing swelling, itching, and redness[1][4].

Q: How is flurandrenolide applied? A: It is applied topically to the affected area, usually 2 to 3 times a day, and should not be used on the face, groin, or underarms unless directed by a doctor[4].

Q: What were the financial impacts of COVID-19 on the market for flurandrenolide? A: The pandemic led to a decline in prescribing rates and revenue for companies like Mayne Pharma and Teligent, Inc.[2][3].

Q: How are companies adapting to the current market dynamics? A: Companies are focusing on cost reductions, restructuring their sales teams, and diversifying their product portfolios to maintain and grow their market presence[2][3].

Q: What is the future outlook for the market of flurandrenolide? A: The market has growth potential, with companies expecting to expand their product portfolios and leverage their existing expertise for strategic growth[3].

Cited Sources

1. DrugBank: Flurandrenolide: Uses, Interactions, Mechanism of Action.
2. Mayne Pharma: 2020 Annual Report.
3. Teligent, Inc.: Annual Reports.
4. WebMD: Flurandrenolide Cream - Uses, Side Effects, and More.