TYMTRAN Drug Patent Profile

Which patents cover Tymtran, and when can generic versions of Tymtran launch?

Tymtran is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in TYMTRAN is ceruletide diethylamine. There is one drug master file entry for this compound. Additional details are available on the ceruletide diethylamine profile page.

Summary for TYMTRAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	65
DailyMed Link:	TYMTRAN at DailyMed

US Patents and Regulatory Information for TYMTRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	TYMTRAN	ceruletide diethylamine	INJECTABLE;INJECTION	018296-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for TYMTRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia And Upjohn	TYMTRAN	ceruletide diethylamine	INJECTABLE;INJECTION	018296-001	Approved Prior to Jan 1, 1982	3,472,832

International Patents for TYMTRAN

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

Country	Patent Number	Title	Estimated Expiration
Sweden	347504
Germany	1643504	DEKAPEPTID L-PYROGLUTAMYL-LGLUTAMINYL-L-ASPARTYL-L-TYROSYL-L-THREONYLGLYCYL-L-TRYPTOPHANYL-L-METHIONYL-LASPARTYL-L-PHENYLALANYLAMID, UND SEINE SALZE SOWIE VERFAHREN ZU DEREN HERSTELLUNG
Norway	119479
Austria	279816
France	1533654	Procédé de préparation d'un décapeptide et de ses sels

TYMTRAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study Relevant to TYMTRAN

Introduction

When a brand-name drug like TYMTRAN (a trade name for tramadol, a pain reliever) loses its patent protection, it opens the door for generic versions to enter the market. Understanding the market dynamics and financial trajectory of generic drugs is crucial for both pharmaceutical companies and policymakers.

Generic Drug Industry Overview

The generic drug industry is characterized by unique institutional and regulatory features that make it an interesting case study for market dynamics. Here, we explore how competition evolves and affects pricing and profitability.

Price and Number of Competitors

Research has shown that generic drug prices decrease as the number of competitors increases. For instance, studies indicate that prices for the initial generic monopolist are 35% to 50% above long-run marginal costs. However, these prices decline as more producers enter the market, approaching long-run marginal costs when there are eight or more competitors[1].

Entry Process and Market Size

The entry process in the generic drug industry is influenced by expected market size and rents. More firms enter, and enter more quickly, in markets with greater expected rents. The timing of entry is not fully under the control of the entrant due to FDA approval uncertainties, which affects the share of aggregate generic profits each firm can capture[1].

Impact of Government Policies

Government policies can significantly affect the market dynamics. For example, increased FDA scrutiny of generic drug applications can raise the cost of obtaining approval, potentially leading to higher prices. On the other hand, simultaneous approval of multiple generic entrants can lead to earlier competition and lower prices, although it may also reduce expected rents and deter future entrants[1].

Economic Implications of Precision Medicines

The shift towards precision medicines, which target smaller patient populations, has economic implications for the drug market. These drugs often command high prices due to their value to specific patient groups, but they may not attract generic competition due to the small market size and high fixed costs of entry[3].

Financial Trajectory of Generic Drugs

Revenue and Profit Growth

Generic drug revenues and profits grow significantly after the initial entry into the market. However, as more competitors enter, profits begin to fall. Typically, the flow of generic industry profits increases as revenues grow but starts declining after five to eight months as more entrants compete away price-cost margins[1].

Cost Structure

The cost structure of generic drug production includes the cost of obtaining FDA approval, manufacturing costs, and marketing expenses. The long-run marginal cost is a key determinant of the price floor, but prices remain above this cost until there is sufficient competition[1].

Market Segmentation and Targeting

Generic drug companies often target specific market segments to maximize their profits. For example, targeting marginalized markets or developing products for specific patient populations can be lucrative strategies. However, the success of these strategies depends on the size of the target market and the level of competition[2].

Case Study: Tramadol (TYMTRAN)

Tramadol, marketed under various brand names including TYMTRAN, is a widely used pain reliever. When tramadol lost its patent protection, generic versions quickly entered the market.

Price Dynamics

Following the entry of generic tramadol, prices dropped significantly. This is consistent with the general trend observed in the generic drug market, where prices decline as the number of competitors increases.

Entry and Competition

Multiple generic manufacturers entered the tramadol market, leading to intense competition. This competition drove prices down, making the drug more affordable for consumers. However, the entry process was influenced by the expected market size and the costs associated with obtaining FDA approval.

Financial Performance

The financial performance of generic tramadol manufacturers followed the typical trajectory. Initial entrants saw significant revenue and profit growth, but as more competitors entered, profits began to decline. The market eventually stabilized with prices approaching long-run marginal costs.

Key Takeaways

• Price Reduction: Generic drug prices decrease significantly as the number of competitors increases.
• Entry Process: The timing and number of entrants are influenced by expected market size and rents.
• Government Policies: Policies can affect the cost of entry and the level of competition.
• Precision Medicines: Targeting smaller patient populations can lead to high prices but may deter generic competition.
• Financial Trajectory: Revenues and profits grow initially but decline as competition increases.

FAQs

Q: How do generic drug prices change with the number of competitors?

A: Generic drug prices fall as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors[1].

Q: What is the impact of government policies on the generic drug market?

A: Government policies, such as increased FDA scrutiny or simultaneous approval of multiple generics, can affect the cost of entry and the level of competition, leading to changes in prices and expected rents[1].

Q: Why do precision medicines often have high prices?

A: Precision medicines target small patient populations and command high prices due to their significant value to these patients, despite the high fixed costs of entry[3].

Q: How does the financial performance of generic drug manufacturers change over time?

A: The financial performance of generic drug manufacturers typically sees initial revenue and profit growth, followed by a decline in profits as more competitors enter the market[1].

Q: What are the key factors influencing the entry of generic drug manufacturers into a market?

A: The key factors include expected market size, rents, and the costs associated with obtaining FDA approval[1].