Clorazepate dipotassium - Generic Drug Details

What are the generic sources for clorazepate dipotassium and what is the scope of freedom to operate?

Clorazepate dipotassium is the generic ingredient in four branded drugs marketed by Able, Am Therap, Dash Pharms, Dava Pharms Inc, Gd Searle Llc, Purepac Pharm, Quantum Pharmics, Rising, Usl Pharma, Warner Chilcott, Watson Labs, Ajenat Pharms, Aurobindo Pharma, Aurolife Pharma Llc, Corepharma, Lederle, Novitium Pharma, Sun Pharm Inds Ltd, Taro, and Alra, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for clorazepate dipotassium. Seven suppliers are listed for this compound.

Summary for clorazepate dipotassium

US Patents:	0
Tradenames:	4
Applicants:	20
NDAs:	62
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	2
Patent Applications:	661
Drug Prices:	Drug price trends for clorazepate dipotassium
What excipients (inactive ingredients) are in clorazepate dipotassium?	clorazepate dipotassium excipients list
DailyMed Link:	clorazepate dipotassium at DailyMed

See drug prices for clorazepate dipotassium

Recent Clinical Trials for clorazepate dipotassium

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
Ranbaxy Laboratories Limited	N/A

See all clorazepate dipotassium clinical trials

Pharmacology for clorazepate dipotassium

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for clorazepate dipotassium

Anti-Anxiety Agents

Anticonvulsants

GABA Modulators

US Patents and Regulatory Information for clorazepate dipotassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gd Searle Llc	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	CAPSULE;ORAL	071729-001	Dec 18, 1987		DISCN	No	No
Warner Chilcott	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	071829-001	Mar 3, 1988		DISCN	No	No
Sun Pharm Inds Ltd	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	076911-002	Sep 29, 2004		DISCN	No	No

Expired US Patents for clorazepate dipotassium

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 SD	clorazepate dipotassium	TABLET;ORAL	017105-005	Approved Prior to Jan 1, 1982	RE28315

Clorazepate dipotassium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clorazepate Dipotassium

Introduction

Clorazepate dipotassium, marketed under the brand name Tranxene, is a benzodiazepine used for the management of anxiety disorders, short-term relief of anxiety symptoms, and as adjunctive therapy in the management of partial seizures and acute alcohol withdrawal. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Indications and Usage

Clorazepate dipotassium is indicated for several clinical uses, including the management of anxiety disorders, short-term relief of anxiety symptoms, adjunctive therapy in partial seizures, and symptomatic relief of acute alcohol withdrawal[2][3][5].

Competitive Landscape

The benzodiazepine market is competitive, with several other drugs available for similar indications. However, clorazepate dipotassium has a unique profile due to its rapid decarboxylation to nordiazepam, which provides a prolonged therapeutic effect. This differentiates it from other benzodiazepines and can influence its market position[2][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of clorazepate dipotassium. The drug is subject to strict regulations due to its potential for abuse, misuse, and addiction. Healthcare providers must carefully consider these risks and follow guidelines for prescribing and monitoring patients[2][3].

Supply Chain and Availability

Recent shortages, such as the one announced by Recordati Rare Diseases in 2022, can significantly impact the market dynamics and financial performance of clorazepate dipotassium. Such shortages can lead to increased costs for manufacturers to address the issue and may result in lost revenue due to unmet demand[1].

Financial Performance

The financial performance of clorazepate dipotassium is influenced by several factors, including sales volume, pricing, and competition. Given its niche but critical indications, the drug can generate significant revenue, especially in markets where it is widely prescribed.

Pricing Strategies

Pricing strategies for clorazepate dipotassium must balance the need for profitability with the need to ensure patient access. The drug's pricing is often influenced by regulatory approvals, reimbursement policies, and competition from generic or branded alternatives[3].

Generic Competition

The presence of generic versions of clorazepate dipotassium can impact its market share and financial performance. Generic competition often leads to lower prices, which can reduce the revenue generated by the branded version but may also increase overall market size due to greater affordability[2].

Research and Development

Continuous research and development are crucial for maintaining market position. Studies on long-term efficacy, safety, and potential new indications can help extend the drug's patent life and enhance its market value. For example, long-term studies in epileptic patients have shown continued therapeutic activity, which supports its use beyond initial indications[2][5].

Safety and Efficacy Concerns

Safety and efficacy concerns, such as the risk of abuse, misuse, and addiction, as well as potential withdrawal reactions, can affect the drug's market dynamics. These risks necessitate careful prescribing practices and ongoing monitoring, which can impact patient compliance and overall market performance[2][3].

Market Trends

Market trends in the pharmaceutical industry, such as the shift towards more targeted therapies and the increasing focus on mental health, can influence the demand for clorazepate dipotassium. Growing awareness of anxiety disorders and the need for effective treatments can drive market growth[2].

Geographical Market

The geographical market for clorazepate dipotassium varies, with different regions having different regulatory environments, healthcare systems, and patient needs. Understanding these regional differences is crucial for effective market strategy and financial planning.

Patient and Prescriber Education

Educating patients and prescribers about the benefits and risks of clorazepate dipotassium is essential for its successful market performance. This includes informing them about proper use, potential side effects, and the importance of gradual tapering to avoid withdrawal reactions[2][3].

Key Takeaways

• Market Indications: Clorazepate dipotassium is used for anxiety disorders, partial seizures, and acute alcohol withdrawal.
• Regulatory Environment: Strict regulations due to abuse and addiction risks.
• Supply Chain: Shortages can impact market dynamics and financial performance.
• Financial Performance: Influenced by sales volume, pricing, and competition.
• Generic Competition: Affects market share and pricing.
• Research and Development: Crucial for maintaining market position.
• Safety and Efficacy Concerns: Impact patient compliance and market performance.
• Market Trends: Growing awareness of mental health can drive demand.

Frequently Asked Questions

Q1: What are the primary indications for clorazepate dipotassium?

• Clorazepate dipotassium is indicated for the management of anxiety disorders, short-term relief of anxiety symptoms, adjunctive therapy in partial seizures, and symptomatic relief of acute alcohol withdrawal[2][3][5].

Q2: What are the risks associated with clorazepate dipotassium?

• The drug is associated with risks of abuse, misuse, and addiction, as well as potential withdrawal reactions. Concomitant use with opioids can lead to profound sedation, respiratory depression, coma, and death[2][3].

Q3: How does clorazepate dipotassium differ from other benzodiazepines?

• Clorazepate dipotassium is rapidly decarboxylated to form nordiazepam, providing a prolonged therapeutic effect. This differentiates it from other benzodiazepines[2][5].

Q4: What impact do shortages have on the market dynamics of clorazepate dipotassium?

• Shortages can lead to increased costs for manufacturers and result in lost revenue due to unmet demand. They also affect patient access and compliance[1].

Q5: How does generic competition affect the market performance of clorazepate dipotassium?

• Generic competition can reduce the market share and revenue of the branded version but may increase overall market size due to greater affordability[2].

Cited Sources

1. Recordati Rare Diseases. Health-Care Provider Letter - Tranxene - March 2022. [PDF]
2. DailyMed. Label: CLORAZEPATE DIPOTASSIUM tablet.
3. FDA. Tranxene® T-TAB® Tablets (clorazepate dipotassium tablets, USP).
4. INCHEM. Clorazepate dipotassium (PIM 327).
5. FDA. Tranxene (clorazepate dipotassium) tablets label. [PDF]