TOLECTIN Drug Patent Profile

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

Tolectin is a drug marketed by Ortho Mcneil Janssen and is included in two NDAs.

The generic ingredient in TOLECTIN is tolmetin sodium. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolectin

A generic version of TOLECTIN was approved as tolmetin sodium by RISING on May 27^th, 1993.

Summary for TOLECTIN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	97
Patent Applications:	4,612
DailyMed Link:	TOLECTIN at DailyMed

US Patents and Regulatory Information for TOLECTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ortho Mcneil Janssen	TOLECTIN 600	tolmetin sodium	TABLET;ORAL	017628-002	Mar 8, 1989		DISCN	Yes	No
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TOLECTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982	3,752,826

International Patents for TOLECTIN

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

Country	Patent Number	Title	Estimated Expiration
France	2081455
Austria	313271
Japan	S5533402	MANUFACTURE OF 55AROYLPYRROLE ACETIC ACID AND ITS SALTS
Spain	416017
Japan	S591711

TOLECTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOLECTIN

Introduction

TOLECTIN, also known as tolmetin sodium, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat various inflammatory conditions, including rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. Understanding the market dynamics and financial trajectory of TOLECTIN involves examining its efficacy, safety profile, market competition, and regulatory environment.

Efficacy and Safety Profile

TOLECTIN is effective in managing both the acute flares and long-term symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. It is as effective as other NSAIDs like aspirin and indomethacin but with a lower incidence of certain adverse effects such as gastrointestinal issues and central nervous system effects[1].

However, like other NSAIDs, TOLECTIN carries significant risks, including cardiovascular thrombotic events, gastrointestinal bleeding, and severe skin reactions. These risks can impact its market acceptance and usage patterns.

Market Competition

The NSAID market is highly competitive, with numerous generic and branded options available. TOLECTIN competes with other NSAIDs such as celecoxib (Celebrex), diclofenac (Voltaren), and ketoprofen. The competition is further intensified by the presence of generic versions of these drugs, which often offer similar efficacy at lower prices.

Generic competition plays a crucial role in shaping the market dynamics. Studies have shown that generic drug prices decline significantly as the number of competitors increases, eventually approaching long-run marginal costs when there are eight or more competitors[4].

Regulatory Environment

The regulatory environment significantly influences the market dynamics of TOLECTIN. The FDA's approval process and post-marketing surveillance can affect the drug's availability and usage. For instance, the FDA's increased scrutiny of generic drug applications in the late 1980s raised the cost of obtaining approval, which could delay market entry for generic versions of TOLECTIN[4].

Additionally, FDA policies such as simultaneous approval of multiple generic entrants can lead to earlier competition and lower prices but may also reduce expected rents, potentially deterring some firms from entering the market[4].

Financial Trajectory

The financial trajectory of TOLECTIN is influenced by several factors, including its market share, pricing, and the overall demand for NSAIDs.

Pricing Dynamics

The pricing of TOLECTIN is affected by the presence of generic competitors. As more generic versions enter the market, the price of TOLECTIN is likely to decrease to remain competitive. This is consistent with the general trend in the generic drug industry where prices fall with the number of competitors[4].

Market Share

TOLECTIN's market share has likely declined over the years due to the increasing availability of generic NSAIDs. The drug's effectiveness and safety profile, while favorable, are not unique enough to maintain a significant market share in the face of cheaper generic alternatives.

Demand and Utilization

The demand for TOLECTIN is driven by the prevalence of conditions it treats, such as rheumatoid arthritis and osteoarthritis. However, the utilization of TOLECTIN may be restricted by prior authorization criteria and formulary placement, as seen in some healthcare systems where it is placed in a Special PA Tier or moved from Tier-1 to Tier-2 based on net cost[3].

Impact of Generic Competition

Generic competition has been a significant factor in the financial trajectory of TOLECTIN. Generic versions of NSAIDs, including tolmetin sodium, enter the market once the patent expires, leading to a rapid decline in sales for the branded version. This is because generic drugs are often priced lower, making them more attractive to both patients and healthcare providers.

Regulatory and Policy Impacts

Regulatory changes and policy decisions also play a crucial role. For example, the FDA's policy of approving multiple generic entrants simultaneously can lead to earlier and more intense competition, further reducing the market share and revenue of branded drugs like TOLECTIN[4].

Market Trends and Future Outlook

The market for NSAIDs, including TOLECTIN, is expected to continue evolving with advancements in pharmaceutical technology and changes in regulatory policies.

• Biosimilars and New Therapies: The emergence of biosimilars and new therapeutic agents could further erode the market share of traditional NSAIDs like TOLECTIN.
• Cost Containment: Efforts to contain healthcare costs may lead to increased use of generic and biosimilar alternatives, impacting the financial trajectory of branded NSAIDs.
• Safety and Efficacy: Ongoing research into the safety and efficacy of NSAIDs may lead to changes in prescribing practices, potentially affecting the market dynamics of TOLECTIN.

Key Takeaways

• Efficacy and Safety: TOLECTIN is effective in treating inflammatory conditions but carries significant risks.
• Market Competition: The NSAID market is highly competitive, with generic competition playing a key role.
• Regulatory Environment: FDA policies and approval processes significantly influence market dynamics.
• Financial Trajectory: The financial performance of TOLECTIN is impacted by pricing dynamics, market share, and demand.
• Generic Competition: Generic versions significantly reduce the market share and revenue of branded NSAIDs.

FAQs

Q: What are the primary uses of TOLECTIN? A: TOLECTIN is used to treat rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis.

Q: What are the significant risks associated with TOLECTIN? A: TOLECTIN carries risks of cardiovascular thrombotic events, gastrointestinal bleeding, and severe skin reactions.

Q: How does generic competition affect TOLECTIN? A: Generic competition leads to lower prices and reduced market share for branded TOLECTIN.

Q: What role does the FDA play in the market dynamics of TOLECTIN? A: The FDA's approval processes and policies on generic drug approvals significantly influence the market dynamics of TOLECTIN.

Q: What is the future outlook for TOLECTIN in the market? A: The market share of TOLECTIN is expected to decline due to increased competition from generics and new therapeutic agents.

Sources

1. TOLECTIN DS (tolmetin sodium) Capsules and TOLECTIN 600 (tolmetin sodium) Tablets - FDA Label.
2. Ketorolac Tromethamine - Patsnap.
3. Board packet - Drug Utilization Review (DUR) Board Meeting - Oklahoma Health Care Authority.
4. Generic Drug Industry Dynamics - Federal Trade Commission.
5. Approach to the Patient With a Musculoskeletal Problem - Springer.