TALACEN Drug Patent Profile

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

Talacen is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in TALACEN is acetaminophen; pentazocine hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; pentazocine hydrochloride profile page.

Summary for TALACEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	136
DailyMed Link:	TALACEN at DailyMed

US Patents and Regulatory Information for TALACEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	TALACEN	acetaminophen; pentazocine hydrochloride	TABLET;ORAL	018458-001	Sep 23, 1982		DISCN	No	No

Expired US Patents for TALACEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TALACEN	acetaminophen; pentazocine hydrochloride	TABLET;ORAL	018458-001	Sep 23, 1982

International Patents for TALACEN

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

Country	Patent Number	Title	Estimated Expiration
Sweden	306743
Sweden	306741
Brazil	6134479
Netherlands	6705466
Switzerland	410960	Verfahren zur Herstellung von Benzazocinderivaten

TALACEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Talacen

Introduction

Talacen, a combination drug containing acetaminophen and pentazocine, is used to manage moderate to severe pain. Understanding its market dynamics and financial trajectory involves analyzing various factors, including its formulation, regulatory environment, abuse patterns, and market trends.

Historical Context of Talacen

Talacen is a successor to Talwin, a pentazocine-only tablet that was widely abused due to its opioid properties. To combat this, the formulation was modified to include naloxone, resulting in Talwin Nx, which was later replaced by Talacen.

The Role of Naloxone in Abuse Deterrence

The addition of naloxone to the formulation of Talwin Nx was a significant step in reducing abuse. Naloxone is pharmacologically inactive when taken orally but active if injected, thereby blocking the narcotic effects of pentazocine if the drug is misused through injection[1].

Impact on Abuse Patterns

The introduction of Talwin Nx, and subsequently Talacen, led to a substantial reduction in abuse. According to the Drug Abuse Warning Network (DAWN), emergency room and medical examiner mentions for pentazocine decreased significantly after the introduction of Talwin Nx. This reduction was evident despite an increase in the number of prescriptions dispensed for pentazocine products[1].

Market Trends and Prescription Patterns

Despite the decline in abuse, the number of prescriptions for pentazocine products, including Talacen, remained stable or even increased in some periods. From 1981 through the first quarter of 1983, the number of prescriptions remained fairly stable, and they increased after the introduction of Talwin Nx[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of controlled substances like Talacen. The Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) closely monitor and regulate these drugs to prevent abuse and ensure safe use. The approval of Talwin Nx by the FDA in late 1982 and its introduction in 1983 were critical regulatory milestones[1].

Financial Trajectory

The financial performance of Talacen is influenced by several factors, including prescription volumes, pricing strategies, and competition within the pain management market. While specific financial data for Talacen is not readily available, the overall trend in prescription volumes and the reduction in abuse suggest a stable or growing market presence.

Prescription Volumes

The increase in prescription volumes for pentazocine products after the introduction of Talwin Nx indicates a positive financial trajectory. The number of prescriptions dispensed quarterly increased, contributing to higher sales and revenue[1].

Pricing Strategies

Pricing strategies for Talacen would be influenced by the competitive landscape in the pain management market. Manufacturers often adjust prices based on market demand, competition, and regulatory pressures.

Competition in the Pain Management Market

The pain management market is highly competitive, with various opioid and non-opioid alternatives available. Talacen competes with other combination drugs and opioid formulations that have abuse-deterrent properties. The market share of Talacen would depend on its efficacy, safety profile, and the ability to deter abuse effectively[3].

Side Effects and Safety Profile

The safety profile of Talacen, including its side effects, is another critical factor influencing its market dynamics. Common side effects include dizziness, nausea, and headache, while severe side effects can include respiratory depression and allergic reactions[2].

Patient Demographics

Understanding patient demographics is essential for marketing and sales strategies. For pain management drugs like Talacen, the primary demographic includes individuals suffering from moderate to severe pain, often including older adults and those with chronic pain conditions.

Impact of External Factors

External factors such as changes in healthcare policies, economic conditions, and public health crises can significantly impact the market dynamics of Talacen. For example, the COVID-19 pandemic led to changes in prescription patterns and telemedicine usage, which could affect the dispensation and sales of controlled substances[4].

Key Takeaways

• The addition of naloxone to Talwin Nx significantly reduced the abuse of pentazocine.
• Despite reduced abuse, prescription volumes for pentazocine products increased after the introduction of Talwin Nx.
• The regulatory environment, including FDA and DEA oversight, is crucial for the market dynamics of Talacen.
• The financial trajectory of Talacen is influenced by prescription volumes, pricing strategies, and competition in the pain management market.
• Side effects and the safety profile of Talacen are important considerations for its market presence.

FAQs

What is Talacen, and how does it differ from its predecessor, Talwin?

Talacen is a combination drug containing acetaminophen and pentazocine, designed to manage moderate to severe pain. It differs from Talwin in that it includes naloxone, an opioid antagonist that helps deter abuse by blocking the narcotic effects if the drug is injected.

How effective is the addition of naloxone in reducing abuse?

The addition of naloxone to Talwin Nx led to a significant reduction in abuse, as evidenced by decreased emergency room and medical examiner mentions for pentazocine after its introduction[1].

What are the common side effects of Talacen?

Common side effects of Talacen include dizziness, nausea, and headache. Severe side effects can include respiratory depression and allergic reactions[2].

How has the COVID-19 pandemic affected the prescription patterns of controlled substances like Talacen?

The COVID-19 pandemic led to changes in prescription patterns, including an initial decline followed by a rebound in stimulant prescriptions. Telemedicine usage also increased, which could impact the dispensation of controlled substances like Talacen[4].

What demographic groups are most likely to be prescribed Talacen?

Talacen is typically prescribed to individuals suffering from moderate to severe pain, often including older adults and those with chronic pain conditions.

Sources

1. CDC Stacks: "Naloxone on the Use and Abuse of Pentazocine" - PDF
2. Drugs.com: "Talacen Side Effects: Common, Severe, Long Term"
3. West Virginia Attorney General: "Abuse-deterrent Opioid Formulations" - PDF
4. DEA Diversion Control Division: "IQVIA Report on Stimulant Trends from 2012 - 2021" - PDF