FELDENE Drug Patent Profile

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

Feldene is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FELDENE is piroxicam. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the piroxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Feldene

A generic version of FELDENE was approved as piroxicam by TEVA on December 11^th, 1992.

Summary for FELDENE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	2
Drug Prices:	Drug price information for FELDENE
What excipients (inactive ingredients) are in FELDENE?	FELDENE excipients list
DailyMed Link:	FELDENE at DailyMed

See drug prices for FELDENE

Recent Clinical Trials for FELDENE

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

Sponsor	Phase
Cairo University	Early Phase 1
Pamukkale University	Phase 4

See all FELDENE clinical trials

US Patents and Regulatory Information for FELDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	AB	RX	Yes	No
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	AB	RX	Yes	Yes

Expired US Patents for FELDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	3,674,876
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	RE29668
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,862,319
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	3,591,584
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,591,564

International Patents for FELDENE

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

Country	Patent Number	Title	Estimated Expiration
Romania	70629
Austria	298503
Hungary	184665	PROCESS FOR PREPARING 3,4-DIHYDRO-2-METHYL-4-OXO-2H-1,2-BENZOTHIAZINE-3-CARBOXYLIC ACID-1,1-DIOXIDE
Spain	462973
Austria	356126

FELDENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FELDENE

Introduction

FELDENE, a nonsteroidal anti-inflammatory drug (NSAID) known by its active ingredient piroxicam, has been a significant player in the management of rheumatoid arthritis and osteoarthritis. To understand its market dynamics and financial trajectory, it is crucial to delve into its pharmacokinetics, clinical efficacy, market competition, and the broader pharmaceutical industry context.

Pharmacokinetics and Clinical Efficacy

FELDENE is well absorbed following oral administration, with peak plasma concentrations generally occurring within three to five hours after medication. It has a prolonged half-life of 50 hours, which allows for once-daily dosing and significant accumulation upon multiple dosing[1][3].

In clinical trials, FELDENE has demonstrated effectiveness in both acute exacerbations and long-term management of rheumatoid arthritis and osteoarthritis. The therapeutic effects are evident early in treatment, with a progressive increase in response over several weeks, primarily in terms of pain relief and subsidence of inflammation[1][3].

Market Position and Competition

FELDENE operates in a competitive NSAID market, where generic competition plays a significant role. The generic drug industry is characterized by rapid entry of firms into markets with high expected rents. Generic drug prices tend to fall as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors[4].

For FELDENE, the introduction of generic versions would likely lead to a decrease in market share and revenue. However, the drug's established brand and therapeutic efficacy can help maintain some market presence even in the face of generic competition.

Financial Trajectory

The financial performance of FELDENE is influenced by several factors, including its pricing strategy, market share, and the overall dynamics of the pharmaceutical industry.

Pricing Strategy

Generic competition can significantly impact the pricing strategy of branded drugs like FELDENE. As more generic competitors enter the market, the prices of generic versions tend to decrease, which can force branded drugs to adjust their pricing to remain competitive. This can lead to a reduction in revenue for the branded drug[4].

Market Share

FELDENE's market share is likely to be affected by the entry of generic competitors. However, its established therapeutic benefits and brand loyalty can help it retain some market share. For instance, FELDENE has been shown to have a lower incidence of minor gastrointestinal effects and tinnitus compared to other NSAIDs like aspirin, which can be a competitive advantage[1][3].

Industry Dynamics

The pharmaceutical industry, particularly the segment dealing with NSAIDs, is subject to various regulatory and competitive pressures. Changes in FDA policies, such as increased scrutiny of generic drug applications or simultaneous approval of multiple generic entrants, can impact the market dynamics and financial performance of drugs like FELDENE[4].

Case Study: Haleon's Strategic Approach

While FELDENE itself is not a product of Haleon, the company's strategic approach in the consumer healthcare market provides valuable insights into how pharmaceutical companies can navigate competitive landscapes.

Haleon, a global leader in consumer healthcare, has a strategy focused on increasing household penetration, capitalizing on new opportunities, maintaining strong execution and financial discipline, and running a responsible business. This approach has allowed Haleon to achieve strong financial results, including organic revenue growth and adjusted operating profit growth, despite challenging economic conditions[2].

Key Takeaways from Haleon's Strategy

• Brand Strength: Haleon's category-leading brands, such as Sensodyne, have maintained or grown market share, highlighting the importance of brand strength in competitive markets.
• Financial Discipline: Haleon's focus on financial discipline has enabled it to de-lever quickly and maintain an attractive financial profile, which is crucial for long-term sustainability.
• Consumer Preference: Driving consumer preference through quality and resilience of brands is essential for maintaining market share and revenue.

Impact of Generic Competition on FELDENE's Financials

The entry of generic competitors can significantly impact FELDENE's financial performance. Here are some key points:

• Revenue Decline: As generic versions of FELDENE enter the market, the revenue from the branded version is likely to decline due to price competition.
• Market Share Reduction: The market share of FELDENE will likely decrease as more generic competitors enter the market.
• Pricing Adjustments: To remain competitive, the pricing strategy of FELDENE may need to be adjusted, which could further impact revenue.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceutical drugs. Changes in FDA policies, such as increased scrutiny of generic drug applications or simultaneous approval of multiple generic entrants, can affect the timing and extent of generic competition. These changes can either accelerate or delay the entry of generic competitors, thereby impacting the financial performance of branded drugs like FELDENE[4].

Conclusion

FELDENE's market dynamics and financial trajectory are influenced by its pharmacokinetics, clinical efficacy, market competition, and the broader pharmaceutical industry context. As a branded NSAID, FELDENE faces significant competition from generic versions, which can lead to a decline in revenue and market share. However, its established therapeutic benefits and brand loyalty can help it retain some market presence.

Key Takeaways

• Pharmacokinetics and Efficacy: FELDENE's prolonged half-life and therapeutic efficacy make it a viable option for managing rheumatoid arthritis and osteoarthritis.
• Market Competition: Generic competition is a significant factor in the NSAID market, leading to potential declines in revenue and market share for branded drugs.
• Financial Discipline: Maintaining strong financial discipline is crucial for long-term sustainability in the pharmaceutical industry.
• Regulatory Environment: Changes in FDA policies can impact the timing and extent of generic competition, affecting the financial performance of branded drugs.

FAQs

What is FELDENE used for?

FELDENE is used for the management of rheumatoid arthritis and osteoarthritis, providing anti-inflammatory, analgesic, and antipyretic activities.

How does FELDENE compare to other NSAIDs?

FELDENE has a lower incidence of minor gastrointestinal effects and tinnitus compared to other NSAIDs like aspirin, making it a preferred option for some patients.

What is the impact of generic competition on FELDENE's revenue?

The entry of generic competitors can lead to a decline in revenue for FELDENE due to price competition and reduced market share.

How does the regulatory environment affect FELDENE's financial performance?

Changes in FDA policies, such as increased scrutiny of generic drug applications or simultaneous approval of multiple generic entrants, can affect the timing and extent of generic competition, thereby impacting FELDENE's financial performance.

What strategies can pharmaceutical companies use to maintain market share in competitive markets?

Companies can focus on increasing household penetration, capitalizing on new opportunities, maintaining strong execution and financial discipline, and running a responsible business to maintain market share and revenue.

Sources

1. FELDENE - accessdata.fda.gov
2. Haleon Annual Report and Form 20-F 2023 - Haleon
3. FELDENE® - accessdata.fda.gov
4. Generic Drug Industry Dynamics - Federal Trade Commission