DIFLUNISAL - Generic Drug Details

What are the generic sources for diflunisal and what is the scope of freedom to operate?

Diflunisal is the generic ingredient in two branded drugs marketed by Ani Pharms, Dastech Intl, Heritage Pharma, Purepac Pharm, Teva, Watson Labs, Zydus Pharms, and Merck, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for diflunisal. Six suppliers are listed for this compound.

Summary for DIFLUNISAL

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	10
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	6
Patent Applications:	7,247
Drug Prices:	Drug price trends for DIFLUNISAL
What excipients (inactive ingredients) are in DIFLUNISAL?	DIFLUNISAL excipients list
DailyMed Link:	DIFLUNISAL at DailyMed

See drug prices for DIFLUNISAL

See drug sales revenues for DIFLUNISAL

Recent Clinical Trials for DIFLUNISAL

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all DIFLUNISAL clinical trials

Pharmacology for DIFLUNISAL

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for DIFLUNISAL

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DIFLUNISAL

N02BA	Salicylic acid and derivatives
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for DIFLUNISAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-002	Apr 19, 1982		DISCN	Yes	No
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-001	Apr 19, 1982		DISCN	Yes	No
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845-002	Aug 16, 2024		RX	No	No
Zydus Pharms	DIFLUNISAL	diflunisal	TABLET;ORAL	203547-001	Jun 16, 2017	AB	RX	No	No
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845-003	Aug 16, 2024		RX	No	No
Ani Pharms	DIFLUNISAL	diflunisal	TABLET;ORAL	074604-001	Jun 10, 1996		DISCN	No	No

Expired US Patents for DIFLUNISAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-001	Apr 19, 1982
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-002	Apr 19, 1982
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-002	Apr 19, 1982
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-001	Apr 19, 1982

DIFLUNISAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diflunisal

Introduction

Diflunisal, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for treating mild to moderate pain, inflammation, osteoarthritis, and rheumatoid arthritis. Here, we delve into the market dynamics and financial trajectory of diflunisal, exploring its current market status, growth prospects, and the factors influencing its demand.

Market Overview

Diflunisal is a salicylate derivative with pharmacologic actions similar to other NSAIDs. It is known for its analgesic, anti-inflammatory, and antipyretic properties, making it a popular choice for managing pain and inflammation associated with various conditions[1].

Current Market Size and Growth

The global market for diflunisal, although not as large as some other NSAIDs, is significant due to its specific use cases. The U.S. market for diflunisal drugs is expected to grow from its current value, although the exact growth rate and market size projections are not explicitly stated in recent reports. However, it is part of a broader NSAID market that continues to see steady demand due to the prevalence of conditions like osteoarthritis and rheumatoid arthritis[4].

Market Drivers

Several factors drive the demand for diflunisal:

Increasing Prevalence of Arthritis

The rising prevalence of osteoarthritis and rheumatoid arthritis, particularly among the aging population, contributes significantly to the demand for NSAIDs like diflunisal. As the global population ages, the need for effective pain management and anti-inflammatory treatments is expected to increase[1].

Clinical Efficacy

Diflunisal's efficacy in reducing pain and inflammation, coupled with its relatively low risk of habituation, tolerance, and addiction, makes it a preferred option for many healthcare providers. Its mechanism of action, involving the inhibition of prostaglandin synthesis, is effective in managing symptoms associated with arthritis and other inflammatory conditions[1].

Generic Availability

The availability of generic versions of diflunisal has made the drug more accessible and affordable for a wider population. Generic prescription products are priced lower than brand-name versions, which helps in increasing market penetration and overall demand[1].

Market Restraints

Despite the positive drivers, there are several challenges that could impact the market trajectory of diflunisal:

Competition from Other NSAIDs

The NSAID market is highly competitive, with numerous other drugs available, such as ibuprofen, naproxen, and celecoxib. This competition can limit the market share of diflunisal, especially if other drugs offer similar or better efficacy profiles[1].

Side Effects and Safety Concerns

Like other NSAIDs, diflunisal can have side effects such as gastrointestinal issues, renal impairment, and cardiovascular risks. These safety concerns can lead to reduced prescriptions and a shift towards alternative treatments with better safety profiles[1].

Financial Trajectory

The financial performance of diflunisal is influenced by several factors:

Pricing

The pricing of diflunisal varies depending on the region and the form of the drug. For example, in the U.S., the cost of diflunisal tablets can range from $1.46 to $1.74 per tablet, making it relatively affordable compared to some other prescription medications[1].

Market Size Projections

While specific projections for the diflunisal market are not detailed, the broader NSAID market is expected to grow steadily. The generic nature of diflunisal and its established use cases suggest that it will continue to be a viable option in the market, contributing to its financial stability and growth[4].

Distribution Channels

The distribution of diflunisal is primarily through pharmacies, both retail and hospital-based. The availability of diflunisal in various forms, including tablets and capsules, and its inclusion in many healthcare systems, ensures a robust distribution network[1].

Key Players

Several pharmaceutical companies are involved in the production and distribution of diflunisal. These include Merck Frosst Canada & Co., Aa Pharma Inc, and Pro Doc Limitee, among others. The presence of multiple manufacturers helps in maintaining a competitive pricing structure and ensuring widespread availability[1].

Conclusion

Diflunisal remains a significant player in the NSAID market due to its efficacy in managing pain and inflammation. While it faces competition from other NSAIDs and has associated safety concerns, its generic availability and established use cases ensure a stable market presence.

Key Takeaways

• Market Demand: Driven by the increasing prevalence of arthritis and the drug's clinical efficacy.
• Competition: Faces competition from other NSAIDs, which can impact market share.
• Safety Concerns: Associated with side effects common to NSAIDs, such as gastrointestinal issues and cardiovascular risks.
• Financial Stability: Supported by its generic availability and affordable pricing.
• Distribution: Widely available through various pharmacies and healthcare systems.

FAQs

What is diflunisal used for?

Diflunisal is used to treat mild to moderate pain, inflammation, osteoarthritis, and rheumatoid arthritis.

How does diflunisal work?

Diflunisal works by inhibiting prostaglandin synthesis via the arachidonic acid pathway, which helps in reducing pain and inflammation.

Is diflunisal addictive?

No, diflunisal is a non-narcotic analgesic and does not cause habituation, tolerance, or addiction.

What are the common side effects of diflunisal?

Common side effects include gastrointestinal issues, renal impairment, and cardiovascular risks.

Is diflunisal available in generic form?

Yes, diflunisal is available in generic form, which makes it more affordable and accessible.

Sources

1. DrugBank Online - Diflunisal: Uses, Interactions, Mechanism of Action
2. Coherent Market Insights - U.S. Transthyretin Amyloidosis Treatment Market Size and Trends
3. Market Research Intellect - Oncolytic Virus Drug Treatment Market Size, Scope And Forecast
4. Market Research Reports - Global Diflunisal Drugs Market Growth 2024-2030