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Last Updated: December 22, 2024

TRANXENE SD Drug Patent Profile


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Which patents cover Tranxene Sd, and what generic alternatives are available?

Tranxene Sd is a drug marketed by Ajenat Pharms and is included in one NDA.

The generic ingredient in TRANXENE SD is clorazepate dipotassium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tranxene Sd

A generic version of TRANXENE SD was approved as clorazepate dipotassium by AUROBINDO PHARMA on July 17th, 1987.

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Summary for TRANXENE SD
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 9
Clinical Trials: 3
DailyMed Link:TRANXENE SD at DailyMed
Drug patent expirations by year for TRANXENE SD
Recent Clinical Trials for TRANXENE SD

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 3
Polish Lymphoma Research GroupPhase 4
Ranbaxy Laboratories LimitedN/A

See all TRANXENE SD clinical trials

US Patents and Regulatory Information for TRANXENE SD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRANXENE SD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-005 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-004 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRANXENE SD

See the table below for patents covering TRANXENE SD around the world.

Country Patent Number Title Estimated Expiration
Germany 1795445 VERFAHREN ZUR HERSTELLUNG VON 2-OXO-2,3-DIHYDRO-1H-1,4-BENZODIAZEPINDERIVATEN ⤷  Subscribe
Brazil 6570433 ⤷  Subscribe
Malaysia 7100180 N-SUBSTITUTED ORTHO-AMINOARYLKETIMINES ⤷  Subscribe
Denmark 138493 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

TRANXENE SD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TRANXENE SD

Introduction

TRANXENE SD, also known as clorazepate dipotassium, is a benzodiazepine used for the management of anxiety disorders, symptomatic relief of acute alcohol withdrawal, and as adjunctive therapy in the management of partial seizures. Here, we will delve into the market dynamics and financial trajectory of this drug.

Indications and Usage

TRANXENE SD is indicated for several clinical uses, including the management of anxiety disorders, the symptomatic relief of acute alcohol withdrawal, and as an adjunct in the management of partial seizures. It is not recommended for use in depressive neuroses, psychotic reactions, or in patients under 9 years of age due to insufficient clinical experience[3].

Market Demand

The demand for benzodiazepines like TRANXENE SD can be influenced by several factors, including the prevalence of anxiety disorders and the need for effective treatments for alcohol withdrawal and epilepsy.

  • Anxiety Disorders: The prevalence of anxiety disorders is significant, and benzodiazepines remain a common treatment option despite the risks associated with their use. This demand is likely to continue, although it may be tempered by the increasing awareness of the risks of benzodiazepine use[3].

  • Alcohol Withdrawal: The need for effective treatments for acute alcohol withdrawal ensures a steady demand for TRANXENE SD in this area.

  • Epilepsy: As an adjunctive therapy in managing partial seizures, TRANXENE SD has a niche but stable market.

Supply Chain and Availability

In recent years, there have been challenges in the supply chain for TRANXENE SD. For instance, in 2022, Recordati Rare Diseases announced a shortage of US-labeled TRANXENE T-TAB® Tablets due to an inability to supply the market. The available lot at that time had an expiration date of July 31, 2022, and was to be sold until April 30, 2022[1].

Financial Performance

The financial performance of TRANXENE SD is tied to its sales and the overall financial health of its manufacturer.

  • Sales Revenue: While specific financial data for TRANXENE SD alone is not readily available, the sales of similar benzodiazepines and the overall revenue of pharmaceutical companies that produce these drugs can provide insights. For example, companies like Travere Therapeutics report significant revenues from their product portfolios, although these figures are not specific to TRANXENE SD[2].

  • Cost and Pricing: The cost and pricing of TRANXENE SD can affect its market dynamics. Benzodiazepines are generally priced competitively, but pricing strategies can vary based on market conditions and regulatory environments.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of TRANXENE SD.

  • FDA Guidelines: The FDA has strict guidelines and warnings associated with the use of benzodiazepines, including TRANXENE SD. These include risks from concomitant use with opioids, abuse, misuse, and addiction, as well as dependence and withdrawal reactions[3].

  • Labeling and Indications: The FDA-approved indications and contraindications for TRANXENE SD are critical in defining its market. For instance, the drug is contraindicated in patients with certain conditions and requires careful monitoring for signs of respiratory depression and sedation when used with opioids.

Competitive Landscape

The competitive landscape for benzodiazepines is complex, with several drugs available for similar indications.

  • Market Share: TRANXENE SD competes with other benzodiazepines and non-benzodiazepine anxiolytics. Its market share can be influenced by factors such as efficacy, safety profile, and prescribing habits of healthcare providers.

  • Generic Competition: The availability of generic versions of benzodiazepines can impact the market share of branded products like TRANXENE SD.

Patient and Prescriber Behavior

Patient and prescriber behavior significantly influence the market dynamics of TRANXENE SD.

  • Prescribing Trends: Prescribing trends for benzodiazepines have been subject to scrutiny due to the risks associated with their use. This has led to a more cautious approach by healthcare providers, which can affect the sales of TRANXENE SD[3].

  • Patient Compliance: Patient compliance with treatment regimens is crucial. The potential for dependence and withdrawal reactions can impact patient adherence and, consequently, the drug's market performance.

Economic Factors

Economic factors, including healthcare policies and reimbursement strategies, can impact the financial trajectory of TRANXENE SD.

  • Reimbursement: Reimbursement policies by insurance providers can influence the affordability and accessibility of TRANXENE SD, thereby affecting its sales.

  • Healthcare Policies: Changes in healthcare policies, such as those related to the opioid crisis, can impact the prescribing and use of benzodiazepines like TRANXENE SD.

Future Outlook

The future outlook for TRANXENE SD is influenced by several factors:

  • Research and Development: Ongoing research into safer alternatives and new treatments for anxiety disorders and epilepsy could impact the long-term demand for TRANXENE SD.

  • Regulatory Changes: Any changes in regulatory guidelines or warnings could affect the drug's market dynamics.

  • Market Trends: Shifts in market trends, such as the increasing use of telemedicine and changes in prescribing habits, can influence the sales and financial performance of TRANXENE SD[4].

Key Takeaways

  • Stable Demand: Despite risks, benzodiazepines like TRANXENE SD continue to have a stable demand due to their efficacy in treating anxiety disorders, alcohol withdrawal, and epilepsy.
  • Regulatory Scrutiny: The drug is subject to strict regulatory guidelines and warnings, which can impact its market dynamics.
  • Competitive Landscape: The competitive landscape is complex, with both branded and generic competitors.
  • Economic Factors: Economic factors such as reimbursement policies and healthcare trends can significantly influence the drug's financial trajectory.

FAQs

What are the primary indications for TRANXENE SD?

TRANXENE SD is indicated for the management of anxiety disorders, the symptomatic relief of acute alcohol withdrawal, and as adjunctive therapy in the management of partial seizures[3].

What are the risks associated with using TRANXENE SD?

The use of TRANXENE SD is associated with risks such as abuse, misuse, and addiction, as well as dependence and withdrawal reactions. It also carries risks when used concomitantly with opioids[3].

Is TRANXENE SD available in generic form?

Yes, generic versions of clorazepate dipotassium are available, which can impact the market share of the branded product.

How does the regulatory environment affect TRANXENE SD?

The FDA has strict guidelines and warnings for the use of benzodiazepines like TRANXENE SD, which can influence prescribing habits and market dynamics[3].

What are the economic factors that influence the sales of TRANXENE SD?

Economic factors such as reimbursement policies, healthcare trends, and changes in prescribing habits can significantly influence the sales and financial performance of TRANXENE SD.

Sources

  1. Recordati Rare Diseases, "Health-Care Provider Letter - Tranxene - March 2022" [PDF].
  2. Travere Therapeutics, "Travere Therapeutics Reports Third Quarter 2024 Financial Results".
  3. FDA, "Tranxene® T-TAB® Tablets" [PDF].
  4. DEA, "IQVIA Report on Stimulant Trends from 2012 - 2022" [PDF].

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