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Last Updated: December 22, 2024

DOLOBID Drug Patent Profile


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

Dolobid is a drug marketed by Merck and is included in one NDA.

The generic ingredient in DOLOBID is diflunisal. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the diflunisal profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dolobid

A generic version of DOLOBID was approved as diflunisal by TEVA on July 31st, 1992.

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Summary for DOLOBID
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 120
Patent Applications: 4,491
DailyMed Link:DOLOBID at DailyMed
Drug patent expirations by year for DOLOBID

US Patents and Regulatory Information for DOLOBID

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 018445-001 Apr 19, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck DOLOBID diflunisal TABLET;ORAL 018445-002 Apr 19, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DOLOBID

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

DOLOBID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DOLOBID (Diflunisal)

Introduction

DOLOBID, also known as diflunisal, is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. It is used primarily for the treatment of osteoarthritis, rheumatoid arthritis, and primary dysmenorrhea. To understand the market dynamics and financial trajectory of DOLOBID, it is essential to delve into its clinical efficacy, market positioning, and the broader pharmaceutical industry context.

Clinical Efficacy and Market Positioning

DOLOBID has been shown to be effective in clinical trials for the treatment of osteoarthritis and rheumatoid arthritis. It has demonstrated comparable efficacy to other NSAIDs like aspirin and ibuprofen, with a lower incidence of gastrointestinal adverse effects compared to aspirin[1].

Comparative Efficacy

In controlled clinical trials, DOLOBID was found to be as effective as aspirin in managing the signs and symptoms of osteoarthritis and rheumatoid arthritis. Its longer-lasting analgesic effect and lower gastrointestinal risk profile make it a viable option for patients requiring long-term anti-inflammatory therapy[1].

Patient Compliance

Studies have indicated that patients treated with DOLOBID had longer-lasting responses and required less frequent dosing compared to other analgesics. This can lead to better patient compliance and potentially lower overall treatment costs[1].

Market Structure and Competition

The pharmaceutical market, particularly for NSAIDs, is highly competitive and influenced by several factors.

Market Segmentation

The market for pharmaceuticals can be segmented into non-reimbursed (over-the-counter) medicines, reimbursed (prescription) medicines, and pharmaceuticals purchased by hospitals. DOLOBID falls under the category of reimbursed prescription medicines, where demand is significantly affected by health insurance policies[3].

Health Insurance and Cost Control

Health insurers play a crucial role in controlling the quality and quantity of drug expenditures. Mechanisms such as co-payments, formularies, and price controls are commonly used to manage costs. For DOLOBID, its inclusion in formularies and the level of reimbursement can significantly impact its market share and financial performance[3].

Financial Trajectory

The financial trajectory of DOLOBID is influenced by several factors, including its pricing, market share, and the overall pharmaceutical industry trends.

Pricing and Reimbursement

The pricing of DOLOBID is subject to various regulatory and market forces. In many OECD countries, pharmaceutical prices are controlled through mechanisms such as co-payments and formularies. The success of DOLOBID in the market depends on its ability to be included in these formularies and to be competitively priced[3].

Generic Competition

The introduction of generic versions of diflunisal can significantly impact the financial performance of the branded product. Generic drugs often lead to a decline in market share and revenue for the original brand, as they offer a cheaper alternative to patients[2].

Research and Development

Pharmaceutical companies invest heavily in research and development (R&D) to maintain market competitiveness. For DOLOBID, ongoing research into targeted delivery systems, such as dendrimers and nanoparticles, could enhance its efficacy and prolong its market relevance[4].

Financial Burden on Consumers

The financial burden of prescription drugs, including DOLOBID, varies among different patient groups.

Trends in Prescription Drug Costs

Studies have shown that while the financial burden of prescription drugs increased from 1999 to 2003, it decreased from 2003 to 2007 due to the increased use of generic drugs and other cost-control measures. However, the burden remains high for certain groups, such as those with public insurance and low incomes[2].

Impact of Health Insurance

Health insurance policies significantly influence the affordability of DOLOBID for consumers. Patients with comprehensive coverage may face lower out-of-pocket costs compared to those without adequate insurance, affecting the drug's market penetration[3].

Market Concentration and Mergers

The pharmaceutical industry is characterized by high market concentration, with a few large companies dominating the market.

Horizontal Mergers

Horizontal mergers between pharmaceutical companies can impact the market dynamics of specific drugs. These mergers can lead to reduced competition and potentially affect innovation in the industry. Regulatory bodies often scrutinize such mergers to ensure they do not stifle innovation or harm consumers[3].

Future Perspectives

The future financial trajectory of DOLOBID will be shaped by several factors:

Innovations in Drug Delivery

Advancements in drug delivery systems, such as dendrimers and nanoparticles, could enhance the efficacy and safety of DOLOBID, potentially increasing its market share and revenue[4].

Regulatory Environment

Changes in regulatory policies, such as those related to pricing and reimbursement, can significantly impact the financial performance of DOLOBID. Countries adopting pharmaco-economic analysis to assess the cost-benefit ratio of drugs may influence the drug's market position[3].

Generic and Biosimilar Competition

The introduction of generic or biosimilar versions of diflunisal will continue to pose a challenge to the branded product. Managing this competition through innovative marketing strategies and enhanced patient services will be crucial for maintaining market share[2].

Key Takeaways

  • Clinical Efficacy: DOLOBID is effective in treating osteoarthritis and rheumatoid arthritis with a favorable safety profile.
  • Market Positioning: It competes in a highly competitive NSAID market influenced by health insurance policies and regulatory controls.
  • Financial Trajectory: The drug's financial performance is impacted by pricing, reimbursement policies, generic competition, and innovations in drug delivery.
  • Consumer Burden: The financial burden on consumers varies, with health insurance playing a critical role in affordability.
  • Market Concentration: The pharmaceutical industry's high market concentration and mergers can affect competition and innovation.

FAQs

What are the primary uses of DOLOBID?

DOLOBID is primarily used for the treatment of osteoarthritis, rheumatoid arthritis, and primary dysmenorrhea.

What are the key benefits of DOLOBID compared to other NSAIDs?

DOLOBID has a longer-lasting analgesic effect and a lower incidence of gastrointestinal adverse effects compared to aspirin.

How does health insurance impact the market for DOLOBID?

Health insurance policies significantly influence the affordability and demand for DOLOBID by affecting out-of-pocket costs and reimbursement levels.

What is the impact of generic competition on DOLOBID?

Generic versions of diflunisal can lead to a decline in market share and revenue for the branded product due to their lower pricing.

How do innovations in drug delivery systems affect DOLOBID's market position?

Innovations such as dendrimers and nanoparticles can enhance the efficacy and safety of DOLOBID, potentially increasing its market share and revenue.

Sources

  1. DOLOBID® (Diflunisal) Label - FDA.
  2. The financial burden from prescription drugs has declined - PubMed.
  3. Competition in the Pharmaceutical Industry - OECD.
  4. Diflunisal Targeted Delivery Systems: A Review - MDPI.

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