TOLECTIN DS Drug Patent Profile

When do Tolectin Ds patents expire, and what generic alternatives are available?

Tolectin Ds is a drug marketed by Ortho Mcneil Janssen and is included in one NDA.

The generic ingredient in TOLECTIN DS 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 Ds

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

Summary for TOLECTIN DS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	49
Patent Applications:	1,081
DailyMed Link:	TOLECTIN DS at DailyMed

US Patents and Regulatory Information for TOLECTIN DS

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 DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TOLECTIN DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982

International Patents for TOLECTIN DS

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

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

TOLECTIN DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOLECTIN DS (Tolmetin Sodium)

Introduction

TOLECTIN DS (tolmetin sodium) is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve signs and symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Position and Competition

TOLECTIN DS operates in a competitive NSAID market, where it competes with other branded and generic NSAIDs. The pharmaceutical industry, particularly the NSAID segment, is characterized by intense competition from both branded and generic products. Companies like Mylan Pharmaceuticals, which has a strong presence in the generic market, pose significant competition to branded NSAIDs like TOLECTIN DS[2].

Product Lifecycle and Revitalization

TOLECTIN DS has been on the market for several decades, and its sales have likely followed the typical product lifecycle curve, with initial growth, maturity, and then decline as generics and newer treatments emerge. However, recent efforts by Galt Pharmaceuticals to reintroduce and promote TOLECTIN DS as a safe, non-opioid pain management option have revitalized interest in the product. This strategy aims to capitalize on the growing need for alternatives to opioid therapies, which have been associated with significant health risks[5].

Financial Performance

The financial performance of TOLECTIN DS can be understood through several key aspects:

Revenue Streams

Historically, TOLECTIN DS generated significant revenue as a branded product. However, with the expiration of its patent, generic versions of tolmetin sodium have entered the market, reducing the revenue from the branded version. Mylan Pharmaceuticals, for example, has been a major player in the generic market, and their financial reports indicate that generic products like tolmetin sodium contribute substantially to their revenue[2].

Pricing Strategies

The pricing of TOLECTIN DS has been a critical factor in its financial trajectory. As the market has become more competitive, especially with the entry of generic versions, pricing strategies have had to adapt. Companies have raised prices on certain products to offset declining sales volumes, but this approach is subject to customer acceptance and competitive responses[2].

Market Share

The market share of TOLECTIN DS has fluctuated over the years. Initially, as a branded product, it held a significant share in the NSAID market. However, with the introduction of generics and other competing NSAIDs, its market share has decreased. The recent efforts by Galt Pharmaceuticals to promote TOLECTIN DS as a non-opioid alternative may help in regaining some market share[5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of TOLECTIN DS. FDA approvals and warnings significantly impact the product's marketability. For instance, the FDA has issued warnings about the cardiovascular and gastrointestinal risks associated with NSAIDs, including TOLECTIN DS, which can affect prescribing patterns and sales[1][4].

Customer and Distribution Dynamics

TOLECTIN DS is sold to various customers, including proprietary and ethical pharmaceutical wholesalers, drug store chains, and public and governmental agencies. The consolidation of customers through mergers and acquisitions has led to severe price deterioration for many generic products, affecting the overall revenue of TOLECTIN DS. However, specialized marketing programs and partnerships, such as the one between Galt Pharmaceuticals and independent pharmacies, can help maintain or increase sales volumes[2][5].

Research and Development

While TOLECTIN DS itself is not a new product, the ongoing research and development in pain management and the push for non-opioid alternatives have kept it relevant. Companies like Galt Pharmaceuticals invest in promoting and reintroducing existing products like TOLECTIN DS, rather than solely focusing on new drug development. This approach can be cost-effective and helps in leveraging the existing clinical benefits of the product[5].

Financial Impact of Litigation and Regulatory Actions

Pharmaceutical companies, including those marketing TOLECTIN DS, often face product liability suits and regulatory actions. These can significantly impact the financial trajectory of the product. For example, Mylan Pharmaceuticals has faced various legal challenges, including FTC complaints and state attorneys general actions, which can affect their overall financial health and, by extension, the sales and revenue of TOLECTIN DS[2].

Recent Developments and Partnerships

Galt Pharmaceuticals' recent partnership with Integra and their commitment to independent pharmacies highlight the ongoing efforts to revitalize TOLECTIN DS. These partnerships aim to diversify product offerings and renew commitments to safe, effective pain management solutions. Such strategies can lead to increased revenue growth, as seen in the 73% revenue growth reported by TRxADE HEALTH in Q2 2022, which is associated with similar market initiatives[5].

Key Takeaways

• Market Competition: TOLECTIN DS faces intense competition from both branded and generic NSAIDs.
• Product Revitalization: Recent efforts by Galt Pharmaceuticals to promote TOLECTIN DS as a non-opioid pain management option have revitalized interest in the product.
• Financial Performance: Revenue has been impacted by generic competition and pricing strategies.
• Regulatory Environment: FDA warnings and approvals significantly influence the product's marketability.
• Customer Dynamics: Consolidation of customers and specialized marketing programs affect sales volumes.
• Research and Development: Focus on promoting existing products rather than new drug development.
• Litigation and Regulatory Actions: Product liability suits and regulatory actions can impact financial health.

FAQs

What is TOLECTIN DS used for?

TOLECTIN DS (tolmetin sodium) is used to relieve signs and symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis.

What are the potential risks associated with TOLECTIN DS?

TOLECTIN DS is associated with increased risks of serious cardiovascular thrombotic events, myocardial infarction, stroke, and gastrointestinal adverse events such as bleeding, ulceration, and perforation of the stomach or intestines[1][4].

How does TOLECTIN DS compare to other NSAIDs?

TOLECTIN DS is as effective as aspirin and indomethacin in controlling disease activity but has a lower incidence of certain adverse effects like gastrointestinal issues and central nervous system effects[1].

What is the recommended dosage for TOLECTIN DS?

The recommended starting dose for adults is 400 mg three times daily (1200 mg daily), with adjustments based on patient response[4].

Who is the current manufacturer of TOLECTIN DS?

Galt Pharmaceuticals has recently introduced TOLECTIN DS to its product portfolio, highlighting their commitment to non-opioid pain management solutions[5].