KENALOG-H Drug Patent Profile

When do Kenalog-h patents expire, and what generic alternatives are available?

Kenalog-h is a drug marketed by Delcor Asset Corp and is included in one NDA.

The generic ingredient in KENALOG-H is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kenalog-h

A generic version of KENALOG-H was approved as triamcinolone acetonide by TARO on October 1^st, 1986.

Summary for KENALOG-H

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	78
Patent Applications:	4,326
DailyMed Link:	KENALOG-H at DailyMed

Recent Clinical Trials for KENALOG-H

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

Sponsor	Phase
Foundation for Orthopaedic Research and Education	Phase 1
Florida Orthopaedic Institute	Phase 1
Next Generation Regenerative Medicine LLC	Phase 1/Phase 2

See all KENALOG-H clinical trials

US Patents and Regulatory Information for KENALOG-H

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Delcor Asset Corp	KENALOG-H	triamcinolone acetonide	CREAM;TOPICAL	086240-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for KENALOG-H

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Delcor Asset Corp	KENALOG-H	triamcinolone acetonide	CREAM;TOPICAL	086240-001	Approved Prior to Jan 1, 1982	4,048,310

International Patents for KENALOG-H

See the table below for patents covering KENALOG-H around the world.

Country	Patent Number	Title	Estimated Expiration
France	2342061
Canada	1085725	STEROIDE POUR APPLICATIONS LOCALES (TOPICAL STEROID FORMULATIONS)
Australia	2236677
Australia	507804
United Kingdom	1578072

KENALOG-H Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Kenalog (Triamcinolone Acetonide)

Introduction

Kenalog, also known as triamcinolone acetonide, is a synthetic glucocorticoid used for its anti-inflammatory effects in various medical conditions. Understanding the market dynamics and financial trajectory of Kenalog is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical Pricing Trends

From 2000 to 2008, the pharmaceutical industry witnessed significant price increases for brand-name drugs, including Kenalog. A study by the Government Accountability Office (GAO) found that 416 brand-name drug products, including different strengths and dosage forms of the same drug brand, experienced extraordinary price increases during this period. Kenalog, being one of these drugs, saw substantial price hikes[1].

Factors Contributing to Price Increases

Several factors contribute to the extraordinary price increases of brand-name prescription drugs like Kenalog:

Market Consolidation

The pace of consolidation among drug companies through mergers and acquisitions has increased, leading to fewer companies producing and marketing drugs. This consolidation can result in greater market domination and less competition, allowing companies to raise prices more freely[1].

Lack of Market Discipline

In the healthcare market, the usual mechanisms that enforce market discipline do not work as they do in other markets. Consumers, often unaware of drug costs due to third-party payers, do not adjust their demand based on price increases. This lack of price sensitivity allows drug companies to raise prices without a corresponding decline in demand[1].

Therapeutic Class and Demand

Kenalog falls under the therapeutic class of anti-inflammatory agents, which is a high-demand category. The consistent demand for such drugs can support higher pricing strategies by pharmaceutical companies[1].

Financial Performance of Manufacturers

Mallinckrodt plc, one of the companies that has produced Kenalog, provides insights into the financial performance associated with this drug.

Revenue and Sales

Mallinckrodt plc has reported significant revenue from its pharmaceutical products, including those in the same therapeutic class as Kenalog. For example, in the first quarter of 2024, Mallinckrodt achieved net sales of $467.8 million, reflecting a 10.2% year-over-year growth[5].

Cost of Sales and Gross Profit

The cost of sales for pharmaceutical companies like Mallinckrodt can be substantial, but the gross profit margins remain significant. In the second quarter of 2024, Mallinckrodt reported a gross profit of $195.0 million, which is 37.9% of the net sales[2].

Research and Development Expenses

Pharmaceutical companies invest heavily in research and development to maintain and expand their product portfolios. For Mallinckrodt, research and development expenses were $27.9 million in the first quarter of 2024, which is about 6.0% of the net sales[5].

Pricing Without Insurance

The cost of Kenalog without insurance can be quite high. For instance, a 1 mL vial of Kenalog-40 (40 mg/mL suspension) can cost around $19 without any discounts or insurance coverage. This highlights the financial burden on patients who are not insured or underinsured[3].

Generic Alternatives and Savings

Generic versions of triamcinolone acetonide offer significant savings for patients. For example, the generic version of Kenalog cream (0.1%) can cost as low as $1 per 30 gm, compared to the brand-name version which costs $19 for the same quantity[3].

Clinical and Therapeutic Value

Kenalog's extended duration of effect and its use in treating various inflammatory conditions contribute to its market value. The drug is absorbed readily and has a sustained therapeutic action over several weeks, making it a valuable treatment option for patients with chronic conditions[4].

Regulatory and Market Environment

The regulatory environment plays a crucial role in the pricing and availability of drugs like Kenalog. Changes in regulatory policies, patent expirations, and the approval of generic alternatives can significantly impact the market dynamics and pricing strategies of pharmaceutical companies.

Impact of Consolidation on Pricing

The consolidation among pharmaceutical companies can lead to a reduction in competition, which in turn can drive up prices. Large companies acquiring smaller ones that specialize in niche markets or specific therapeutic classes can result in market domination and higher prices for drugs like Kenalog[1].

Consumer and Patient Impact

The high prices of brand-name drugs like Kenalog can have a significant impact on consumers and patients. Those without adequate insurance coverage may face substantial out-of-pocket costs, which can lead to non-adherence to treatment or seeking alternative, potentially less effective treatments.

Future Outlook

Given the current market trends and financial performance of pharmaceutical companies, it is likely that the prices of brand-name drugs like Kenalog will continue to be a subject of scrutiny. Regulatory changes, increased competition from generics, and consumer advocacy may influence future pricing strategies.

Key Takeaways

• Historical Price Increases: Kenalog has experienced significant price increases from 2000 to 2008, aligning with broader trends in the pharmaceutical industry.
• Market Factors: Consolidation, lack of market discipline, and high demand contribute to the extraordinary price increases of brand-name drugs.
• Financial Performance: Manufacturers like Mallinckrodt plc report substantial revenues and gross profits from their pharmaceutical products.
• Pricing Without Insurance: The cost of Kenalog without insurance is high, but generic alternatives offer significant savings.
• Regulatory Environment: Changes in regulatory policies and market competition can impact the pricing and availability of Kenalog.

FAQs

Q: What are the main factors contributing to the high prices of Kenalog?

A: The main factors include market consolidation, lack of market discipline, and high demand in the therapeutic class of anti-inflammatory agents.

Q: How does the cost of Kenalog compare to its generic alternatives?

A: The generic version of Kenalog is significantly cheaper than the brand-name version, offering substantial savings for patients.

Q: What is the impact of consolidation among pharmaceutical companies on drug prices?

A: Consolidation can lead to reduced competition, allowing companies to raise prices more freely and resulting in higher prices for drugs like Kenalog.

Q: How does the regulatory environment affect the pricing of Kenalog?

A: Regulatory changes, patent expirations, and the approval of generic alternatives can significantly impact the pricing strategies of pharmaceutical companies.

Q: What is the future outlook for the pricing of Kenalog?

A: The future pricing of Kenalog may be influenced by regulatory changes, increased competition from generics, and consumer advocacy, potentially leading to more competitive pricing.

Sources

1. GAO-10-201, Brand-Name Prescription Drug Pricing - Government Accountability Office.
2. Mallinckrodt plc Reports Second Quarter 2024 Financial Results and Updated 2024 Guidance - Mallinckrodt plc.
3. How much is triamcinolone acetonide (Kenalog) without insurance? - SingleCare.
4. Kenalog-40: Package Insert / Prescribing Information - Drugs.com.
5. Mallinckrodt plc Reports First Quarter 2024 Financial Results and Updated 2024 Guidance - Mallinckrodt plc.