TRANXENE Drug Patent Profile

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

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

The generic ingredient in TRANXENE 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

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

Summary for TRANXENE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	3
Patent Applications:	339
Drug Prices:	Drug price information for TRANXENE
What excipients (inactive ingredients) are in TRANXENE?	TRANXENE excipients list
DailyMed Link:	TRANXENE at DailyMed

See drug prices for TRANXENE

Recent Clinical Trials for TRANXENE

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
Polish Lymphoma Research Group	Phase 4
Ranbaxy Laboratories Limited	N/A

See all TRANXENE clinical trials

US Patents and Regulatory Information for TRANXENE

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	clorazepate dipotassium	CAPSULE;ORAL	017105-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ajenat Pharms	TRANXENE SD	clorazepate dipotassium	TABLET;ORAL	017105-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ajenat Pharms	TRANXENE	clorazepate dipotassium	TABLET;ORAL	017105-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TRANXENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ajenat Pharms	TRANXENE	clorazepate dipotassium	TABLET;ORAL	017105-007	Approved Prior to Jan 1, 1982	RE28315
Ajenat Pharms	TRANXENE	clorazepate dipotassium	CAPSULE;ORAL	017105-001	Approved Prior to Jan 1, 1982	RE28315
Ajenat Pharms	TRANXENE	clorazepate dipotassium	TABLET;ORAL	017105-008	Approved Prior to Jan 1, 1982	RE28315

International Patents for TRANXENE

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

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

TRANXENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tranxene

Introduction

Tranxene, known generically as Clorazepate Dipotassium, is a benzodiazepine used to treat anxiety, alcohol withdrawal, and seizures. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Revenue

The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, as reported by IQVIA/IMS Health[1].

• This figure indicates a stable market demand for the drug, driven by its therapeutic applications.

Generic Competition

ANI Pharmaceuticals recently announced the FDA approval and imminent launch of their generic version of Tranxene, Clorazepate Dipotassium Tablets USP[1].

• The entry of generic competitors can impact the market share and pricing of the branded version, potentially reducing revenue for the original manufacturer.

Therapeutic Indications

Tranxene is indicated for the symptomatic relief of acute alcohol withdrawal and for the management of anxiety and seizures[3].

• The drug's multiple therapeutic uses contribute to its market stability and demand.

Risks and Side Effects

Despite its therapeutic benefits, Tranxene has significant risks, including physical dependence, withdrawal symptoms, and potential for misuse and addiction[2][3].

• These risks can affect prescribing patterns and patient compliance, influencing the drug's market performance.

Contraindications and Warnings

Tranxene is contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. It also carries warnings about concomitant use with opioids, which can result in profound sedation, respiratory depression, coma, and death[3].

• These contraindications and warnings may limit its prescription and use, impacting sales.

Treatment and Addiction

The treatment for Tranxene addiction involves medically supervised detoxification, behavioral therapies like cognitive-behavioral therapy (CBT), and support groups[2].

• The need for comprehensive treatment programs can create additional revenue streams through healthcare services but also highlights the drug's potential for misuse.

Social and Behavioral Risks

Tranxene addiction leads to significant social and behavioral issues, including strained relationships, job loss, legal problems, and financial instability[2].

• These societal impacts can influence public health policies and prescribing practices, affecting the drug's market dynamics.

Mental Health Risks

Prolonged use of Tranxene exacerbates or causes severe mood disorders such as depression and anxiety. It also leads to cognitive impairment and emotional instability[2].

• These mental health risks are critical factors in the drug's prescribing and use patterns.

Financial Implications of Misuse

The financial implications of Tranxene misuse are substantial, including increased healthcare costs for treatment and the economic burden of lost productivity and legal issues[2].

• These costs can affect the overall financial trajectory of the drug, as healthcare systems and insurers may become more cautious in their coverage and reimbursement policies.

Competitive Landscape

The benzodiazepine market is competitive, with several other drugs available for similar indications. The entry of generic versions, like ANI Pharmaceuticals' Clorazepate Dipotassium Tablets, adds to this competition[1].

• A competitive market can drive prices down and impact the revenue of branded drugs.

Regulatory Environment

Regulatory bodies closely monitor benzodiazepines due to their potential for abuse and addiction. This scrutiny can lead to stricter prescribing guidelines and monitoring programs, affecting market dynamics[3].

• Regulatory changes can significantly influence the drug's market performance and financial trajectory.

Patient Demographics

The patient demographics for Tranxene include individuals suffering from anxiety, alcohol withdrawal, and seizures. The drug's use can be influenced by demographic trends, such as age and gender, which may impact its market[4].

• Understanding these demographics is crucial for marketing and sales strategies.

Future Outlook

Given the stable market demand and the entry of generic competitors, the financial trajectory for Tranxene is likely to be influenced by pricing pressures and regulatory oversight.

• Pharmaceutical companies may need to focus on enhancing patient access, improving safety profiles, and developing new formulations to maintain market share.

Key Takeaways

• The U.S. market for Clorazepate Dipotassium Tablets is valued at approximately $25.8 million.
• Generic competition is a significant factor in the market dynamics.
• The drug's therapeutic indications and risks influence its market performance.
• Regulatory environment and patient demographics play crucial roles in shaping the market.
• The financial implications of misuse and addiction are substantial.

FAQs

Q: What is the current market size for Clorazepate Dipotassium Tablets in the U.S.? A: The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million[1].

Q: What are the main therapeutic indications for Tranxene? A: Tranxene is indicated for the symptomatic relief of acute alcohol withdrawal and for the management of anxiety and seizures[3].

Q: What are the risks associated with long-term use of Tranxene? A: Long-term use of Tranxene can lead to physical dependence, withdrawal symptoms, and potential for misuse and addiction[2][3].

Q: How does the entry of generic versions affect the market for Tranxene? A: The entry of generic versions can reduce the market share and pricing of the branded version, impacting revenue[1].

Q: What are the financial implications of Tranxene misuse? A: The financial implications include increased healthcare costs for treatment, lost productivity, and legal issues[2].

Sources

1. ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP - ANI Pharmaceuticals
2. Tranxene Addiction: Effects, Risks, Symptoms, Causes & Treatment - Grove Treatment
3. TRANXENE tablets - FDA
4. IQVIA Report on Stimulant Trends from 2012 - 2022 - IQVIA
5. Tranxene (Clorazepate) Short- & Long-Term Side Effects - Recovery First