TALWIN NX Drug Patent Profile

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

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

The generic ingredient in TALWIN NX is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Talwin Nx

A generic version of TALWIN NX was approved as naloxone hydrochloride; pentazocine hydrochloride by WATSON LABS on January 21^st, 1997.

Summary for TALWIN NX

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	TALWIN NX at DailyMed

Recent Clinical Trials for TALWIN NX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stanley Medical Research Institute	Phase 2
Mclean Hospital	Phase 2

See all TALWIN NX clinical trials

US Patents and Regulatory Information for TALWIN NX

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 NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982		DISCN	No	No

Expired US Patents for TALWIN NX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982	4,105,659

International Patents for TALWIN NX

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

Country	Patent Number	Title	Estimated Expiration
Sweden	306743
Sweden	306741
Brazil	6134479

Supplementary Protection Certificates for TALWIN NX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

TALWIN NX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TALWIN NX

Introduction

TALWIN NX, a formulation of pentazocine and naloxone hydrochlorides, was introduced as a response to the rampant abuse of its predecessor, TALWIN. This article delves into the market dynamics and financial trajectory of TALWIN NX, highlighting its impact on the pharmaceutical market and the financial implications of its introduction.

Background of TALWIN and the Need for Reformulation

TALWIN, containing only pentazocine, was widely abused in the late 1970s and early 1980s, particularly in the form of "T's and blues," where pentazocine tablets were combined with the antihistamine tripelennamine and injected intravenously to produce a heroin-like high[4].

Introduction of TALWIN NX

To combat this abuse, the manufacturer reformulated TALWIN by adding 0.5 mg of naloxone hydrochloride to create TALWIN NX. Naloxone, an opioid antagonist, is pharmacologically inactive when taken orally but active if administered parenterally, thereby deterring injection misuse[4][5].

Market Impact

Reduction in Abuse

The introduction of TALWIN NX in 1983 significantly reduced the abuse of pentazocine. Data from the Drug Abuse Warning Network (DAWN) and the National Institute of Drug Abuse showed a substantial decrease in emergency room and medical examiner mentions related to pentazocine abuse. Specifically, there was a 70% decrease in emergency room mentions and a 71% decrease in medical examiner mentions per million prescriptions in the two years following the introduction of TALWIN NX[4].

Prescription Trends

Despite the reduction in abuse, the number of prescriptions for pentazocine products remained stable and even increased after the introduction of TALWIN NX. This suggests that the reformulation did not significantly impact the legitimate use of the drug for pain relief[4].

Financial Trajectory

Initial Investment and Regulatory Approval

The reformulation and approval process for TALWIN NX involved significant investment from the manufacturer. The product was approved for marketing in late 1982 and introduced in the second quarter of 1983. This process, including regulatory approvals and manufacturing adjustments, would have incurred substantial costs[4].

Revenue and Sales

The financial performance of TALWIN NX was influenced by its continued prescription stability and the reduction in abuse-related costs. While the exact financial figures are not provided, the stable prescription rates and reduced abuse incidents suggest that the product maintained a steady revenue stream. The decrease in abuse also likely reduced the financial burden associated with abuse-related medical emergencies and law enforcement activities[4].

Cost Savings and Public Health Impact

The reduction in abuse and related medical emergencies resulted in significant cost savings for healthcare systems and public health programs. For instance, the decrease in emergency room visits and medical examiner cases directly related to pentazocine abuse would have lowered healthcare costs and alleviated some of the financial strain on public health resources[4].

Market Dynamics

Competitive Landscape

TALWIN NX entered a market where opioid analgesics were widely used but also heavily abused. The reformulation positioned TALWIN NX as a safer alternative, potentially attracting patients and prescribers looking for an abuse-deterrent opioid. This competitive advantage helped maintain market share despite the presence of other opioid formulations[3].

Regulatory Environment

The introduction of TALWIN NX was closely monitored by regulatory bodies, including the FDA. The success of this reformulation in reducing abuse set a precedent for future abuse-deterrent formulations. This regulatory environment encouraged other manufacturers to develop similar abuse-deterrent products, shaping the broader opioid market[4].

Patient and Prescriber Acceptance

The acceptance of TALWIN NX by patients and prescribers was crucial for its market success. The drug's efficacy in pain relief, combined with its abuse-deterrent properties, made it a preferred choice for many. However, some patients might have experienced side effects such as hallucinations, disorientation, and confusion, which could have influenced prescribing patterns[5].

Challenges and Limitations

Side Effects and Contraindications

TALWIN NX, like other opioids, carries significant risks, including physical and psychological dependence, respiratory depression, and potential for severe reactions in certain patient populations. These factors necessitate careful medical supervision and periodic re-evaluation of therapy, which can impact its market appeal and financial performance[5].

Misuse by Other Routes

While the addition of naloxone significantly reduced parenteral misuse, TALWIN NX was still subject to oral misuse and abuse. This ongoing risk required continued vigilance and monitoring by healthcare providers and regulatory agencies[1][5].

Key Takeaways

• Abuse Reduction: TALWIN NX significantly reduced pentazocine abuse through the addition of naloxone.
• Stable Prescriptions: Despite reduced abuse, prescription rates for TALWIN NX remained stable.
• Financial Impact: The reformulation likely resulted in cost savings due to reduced abuse-related medical emergencies.
• Market Positioning: TALWIN NX positioned itself as a safer alternative in the opioid market.
• Regulatory Influence: The success of TALWIN NX influenced the development of future abuse-deterrent opioid formulations.

FAQs

Q: What is TALWIN NX, and how does it differ from TALWIN?

A: TALWIN NX is a formulation of pentazocine and naloxone hydrochlorides, designed to deter abuse by adding naloxone, an opioid antagonist that is active if administered parenterally but inactive orally.

Q: How did the introduction of TALWIN NX impact pentazocine abuse?

A: The introduction of TALWIN NX significantly reduced pentazocine abuse, with a 70% decrease in emergency room mentions and a 71% decrease in medical examiner mentions per million prescriptions in the two years following its introduction.

Q: What are the potential side effects of TALWIN NX?

A: TALWIN NX can cause physical and psychological dependence, respiratory depression, hallucinations, disorientation, and confusion. It also carries risks of severe reactions in certain patient populations.

Q: Is TALWIN NX contraindicated in any patient groups?

A: Yes, TALWIN NX is contraindicated in patients who are hypersensitive to either pentazocine or naloxone and should be used with extreme caution in patients with head injuries, increased intracranial pressure, or chronic obstructive pulmonary disease.

Q: How does the addition of naloxone affect the pharmacologic action of pentazocine?

A: The addition of naloxone does not interfere with the pharmacologic action of pentazocine when taken orally but neutralizes its effect if the product is misused by injection.

Sources

1. Sanofi US. Talwin Nx (pentazocine and naloxone hydrochlorides) [PDF].
2. Oregon.gov. BOARD MEETING AGENDA [PDF].
3. West Virginia Attorney General. Abuse-deterrent Opioid Formulations [PDF].
4. PubMed. The impact of the addition of naloxone on the use and abuse of pentazocine.
5. FDA. TALWIN Nx CIV pentazocine hydrochloride and naloxone hydrochloride [PDF].