TALWIN COMPOUND Drug Patent Profile

Which patents cover Talwin Compound, and what generic alternatives are available?

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

The generic ingredient in TALWIN COMPOUND is aspirin; pentazocine hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; pentazocine hydrochloride profile page.

Summary for TALWIN COMPOUND

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	TALWIN COMPOUND at DailyMed

US Patents and Regulatory Information for TALWIN COMPOUND

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	TALWIN COMPOUND	aspirin; pentazocine hydrochloride	TABLET;ORAL	016891-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TALWIN COMPOUND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TALWIN COMPOUND	aspirin; pentazocine hydrochloride	TABLET;ORAL	016891-001	Approved Prior to Jan 1, 1982

International Patents for TALWIN COMPOUND

See the table below for patents covering TALWIN COMPOUND around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	306743
Sweden	306741
Brazil	6134479
Netherlands	6705466
Switzerland	410960	Verfahren zur Herstellung von Benzazocinderivaten
Austria	246157

TALWIN COMPOUND Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of TALWIN Nx (Pentazocine and Naloxone Hydrochlorides)

Introduction

TALWIN Nx, a formulation combining pentazocine and naloxone hydrochlorides, was introduced in the early 1980s as a response to the growing issue of pentazocine abuse. This article delves into the market dynamics and financial trajectory of TALWIN Nx, highlighting its impact on the pharmaceutical market and public health.

Historical Context of Pentazocine

Pentazocine, initially marketed as Talwin, was approved by the FDA in 1967 as a nonnarcotic analgesic for moderate to severe pain. It was believed to have no significant potential for abuse, but this assumption was quickly proven incorrect as reports of patient dependence began to emerge in 1968[1].

The Rise of Pentazocine Abuse

By the late 1970s, pentazocine abuse had become a significant public health concern, particularly with the advent of "T's and blues" abuse, where pentazocine was combined with antihistamines or other substances. This led to a surge in emergency room and medical examiner mentions related to pentazocine misuse[1].

Introduction of TALWIN Nx

To address the abuse issue, the manufacturer reformulated Talwin by adding 0.5 mg of naloxone hydrochloride to create TALWIN Nx. Naloxone is pharmacologically inactive when taken orally but acts as a potent narcotic antagonist if injected, thereby deterring parenteral misuse. TALWIN Nx was approved by the FDA in late 1982 and introduced in the second quarter of 1983, replacing the original Talwin tablets in the U.S. market[1][3].

Impact on Abuse Patterns

The introduction of TALWIN Nx significantly reduced pentazocine abuse. According to the Drug Abuse Warning Network (DAWN), emergency room mentions and medical examiner mentions for pentazocine decreased by 70% and 71%, respectively, in the two years following the introduction of TALWIN Nx. This reduction occurred despite an increase in the number of prescriptions dispensed for pentazocine products during the same period[1].

Market Dynamics

Prescription Trends

The number of prescriptions for pentazocine products remained stable from 1981 through the first quarter of 1983 and then increased after the introduction of TALWIN Nx. This indicates that the reformulation did not deter legitimate use but effectively reduced misuse[1].

Public Health Impact

The reduction in abuse was a significant public health victory. The decrease in emergency room and medical examiner mentions reflected a lower incidence of severe reactions and overdose cases associated with pentazocine misuse.

Regulatory Environment

The FDA's approval and the subsequent discontinuation of the original Talwin tablets underscored the regulatory body's commitment to addressing drug abuse. This move set a precedent for future formulations aimed at reducing drug misuse.

Financial Trajectory

Initial Investment and Approval

The development and approval of TALWIN Nx involved significant investment from the manufacturer. While specific financial figures for the development phase are not available, the reformulation and approval process would have incurred substantial costs.

Market Performance

The increase in prescriptions post-reformulation suggests that TALWIN Nx maintained or possibly increased its market share. However, the financial performance of TALWIN Nx would also depend on factors such as production costs, pricing strategies, and competition within the analgesic market.

Long-term Financial Impact

The long-term financial impact of TALWIN Nx would be influenced by its continued use and any subsequent changes in the market or regulatory environment. Given the reduced abuse potential, TALWIN Nx likely maintained a stable revenue stream for the manufacturer, although specific financial data is not provided in the available sources.

Challenges and Considerations

Misuse by Oral Route

While TALWIN Nx effectively reduced parenteral misuse, it was still subject to oral misuse. This highlights the ongoing challenge of balancing analgesic efficacy with abuse deterrence[3].

Regulatory and Public Health Oversight

Continuous monitoring by regulatory bodies and public health organizations is crucial to ensure that the drug is used as intended and that any emerging issues are addressed promptly.

Key Takeaways

• Reformulation Success: The addition of naloxone to pentazocine significantly reduced abuse.
• Market Stability: Prescriptions for TALWIN Nx increased after its introduction, indicating stable or increased market share.
• Public Health Impact: The reformulation led to a substantial reduction in emergency room and medical examiner mentions.
• Regulatory Influence: The FDA's approval and the discontinuation of the original Talwin tablets set a precedent for addressing drug abuse through formulation changes.

FAQs

What was the primary reason for the reformulation of Talwin to TALWIN Nx?

The primary reason was to reduce the abuse potential of pentazocine by adding naloxone, which acts as a narcotic antagonist if injected.

How did the introduction of TALWIN Nx affect pentazocine abuse?

The introduction of TALWIN Nx led to a 70% decrease in emergency room mentions and a 71% decrease in medical examiner mentions related to pentazocine misuse.

What is the role of naloxone in TALWIN Nx?

Naloxone is pharmacologically inactive when taken orally but acts as a potent narcotic antagonist if injected, thereby deterring parenteral misuse.

Did the reformulation affect the legitimate use of pentazocine?

No, the number of prescriptions for pentazocine products remained stable or increased after the introduction of TALWIN Nx, indicating that legitimate use was not deterred.

What were the regulatory steps taken to address pentazocine abuse?

The FDA approved the reformulated product, TALWIN Nx, and the manufacturer discontinued the distribution of the original Talwin tablets in the U.S.

Sources

1. CDC Stacks: Naloxone on the Use and Abuse of Pentazocine.
2. Trevena: Trevena Reports Fourth Quarter 2022 Results and Provides Business Update.
3. Sanofi US: Talwin Nx (pentazocine and naloxone hydrochlorides).
4. DEA: IQVIA Report on Stimulant Trends from 2012-2021.
5. Oregon State Board of Pharmacy: BOARD MEETING AGENDA.