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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	6,331
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
Ajenat Pharms	TRANXENE	clorazepate dipotassium	TABLET;ORAL	017105-007	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Watson Labs	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	071852-001	Feb 9, 1988		DISCN	No	No
Usl Pharma	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	CAPSULE;ORAL	071242-001	Jun 23, 1987		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	017105-006	Approved Prior to Jan 1, 1982	RE28315
Ajenat Pharms	TRANXENE SD	clorazepate dipotassium	TABLET;ORAL	017105-004	Approved Prior to Jan 1, 1982	RE28315
Ajenat Pharms	TRANXENE	clorazepate dipotassium	CAPSULE;ORAL	017105-001	Approved Prior to Jan 1, 1982	RE28315

Market Dynamics and Financial Trajectory for Clorazepate Dipotassium

Last updated: July 27, 2025

---

Introduction

Clorazepate dipotassium is an anxiolytic drug belonging to the benzodiazepine class, primarily used for managing anxiety, seizures, and alcohol withdrawal symptoms. Since its market approval, it has played a significant role within the niche of short- to medium-term benzodiazepine therapies. As pharmaceutical markets evolve with shifting regulations and therapeutic paradigms, understanding the market dynamics and financial trajectory of clorazepate dipotassium becomes crucial for stakeholders, including manufacturers, investors, and healthcare providers.

---

Regulatory Landscape and Market Approvals

Initially approved in the late 20th century, clorazepate dipotassium gained FDA approval for indicated uses such as anxiety and alcohol withdrawal. However, regulatory agencies globally have strengthened oversight over benzodiazepines due to concerns surrounding dependence, misuse, and side effects.

The drug’s regulatory trajectory has an impact on its market penetration:

• United States: While still approved, market presence has diminished, owing to the rise of newer anxiolytics and stricter prescription regulations.
• Europe and Asia: Regulatory variability influences availability, with some regions phasing out older benzodiazepines in favor of SSRIs or other anxiolytics, constraining growth potential.

Market Dynamics

1. Competitive Landscape

Clorazepate dipotassium operates within a highly competitive benzodiazepine segment dominated by drugs like diazepam, lorazepam, and alprazolam. Competitive pressures stem from:

• Emergence of Non-Benzodiazepine Drugs: SSRIs, SNRIs, and other anxiolytics, which offer similar efficacy with lower dependence risk.
• Generic Competition: Patent expirations have led to multiple generic versions, intensifying price competition and reducing margins.

2. Therapeutic Shifts and Prescribing Trends

Over recent decades, prescribing patterns have shifted towards drugs with improved safety profiles. Increased awareness regarding benzodiazepine dependence has led to cautious prescribing, especially in vulnerable populations such as the elderly. This trend constrains demand growth for clorazepate dipotassium.

3. Regulatory and Safety Considerations

Regulatory agencies have imposed stricter controls on benzodiazepines, including prescription limits and scheduled classifications. These measures influence market size within key geographies and impede large-volume sales growth.

4. Market Segmentation and Customer Base

Its primary users include mental health clinics, hospitals, and outpatient clinics. Growing emphasis on non-benzodiazepine, non-scheduled anxiolytics exerts downward pressure on its market share.

---

Financial Trajectory and Revenue Forecast

1. Historical Revenue Performance

• Declining Trends: Market data indicates a decline in overall revenue for clorazepate dipotassium since the early 2000s, paralleling the global decline in benzodiazepine prescriptions.
• Generic Proliferation: Price erosion due to generics has further compressed profit margins.

2. Market Forecast for the Next Decade

Based on current trends, the financial outlook appears constrained:

• Limited Growth: The global antidepressant and anxiolytic market is projected to grow at a compound annual growth rate (CAGR) of 2-4% (2023–2030), but clorazepate dipotassium's share may decline due to competition.
• Potential Niche Expansion: Despite limitations, a niche market for specific patient subsets (e.g., those intolerant to newer drugs) might sustain modest revenues.

3. Impact of Patent Expirations and Generics

The expiration of patents has led to a proliferation of low-cost generics, compressing prices and expected revenues. Without new formulations or indications, revenue growth is unlikely.

4. Investment and R&D Considerations

Limited R&D investment in clorazepate dipotassium indicates a mature or declining product life cycle. Resources tend to focus on novel therapeutics with higher growth potential.

---

Market Opportunities and Challenges

Opportunities:

• Niche Applications: Specific cases where newer therapies are contraindicated can sustain demand.
• Regulatory Reclassification: Depending on regulatory changes, reclassification strategies might renew market interest.
• Formulation Innovation: Extended-release or combination therapies could create minor revenue upticks.

Challenges:

• Dependence Risks: Growing concern about benzodiazepine dependence hampers prescription volume.
• Regulatory Restrictions: Tightened controls limit accessibility.
• Therapeutic Alternatives: Emerging drugs with improved safety profiles threaten long-term viability.

---

Key Market Drivers and Restraints

Drivers	Restraints
Increasing burden of anxiety disorders	Rising dependence and abuse concerns
Generic drug prevalence	Stringent regulation and control measures
Cost-effective generic formulations	Competition from non-benzodiazepine anxiolytics
Growing aging population with comorbidities	Shifts in prescribing guidelines favoring newer drugs

---

Conclusion

The market dynamics of clorazepate dipotassium reflect a mature, shrinking segment within the anxiolytic landscape. Regulatory constraints, therapeutic shifts, and competitive pressures have curtailed its growth trajectory. Financially, revenues are declining, with incremental niche opportunities for selected patient populations. Market participants should view it as a low-growth asset with potential strategies focusing on repositioning or niche targeting instead of large-scale expansion.

---

Key Takeaways

• Market Contraction: The relevance of clorazepate dipotassium is diminishing globally due to safety concerns, regulatory restrictions, and competition from newer anxiolytics.
• Revenue Decline: Generic proliferation and declining prescribing patterns have led to decreased revenues, with minimal prospects for significant growth.
• Regulatory Impact: Stricter controls have both limited access and reduced market opportunities, emphasizing the need for strategic adaptation.
• Niche Market Potential: Limited to specific patient subsets, there remains a niche for this drug where newer therapies are contraindicated or unavailable.
• Strategic Focus: Companies should consider repositioning or diversifying within their portfolios, given the limited growth outlook for clorazepate dipotassium.

---

FAQs

1. What are the primary factors limiting the market growth of clorazepate dipotassium?
Regulatory restrictions on benzodiazepines, rise of alternative therapies like SSRIs, concerns over dependence, and patent expirations leading to price competition have collectively constrained market expansion.

2. How does the regulatory environment affect the future prospects of clorazepate dipot potassium?
Enhanced regulatory oversight, prescription restrictions, and scheduling limitations reduce prescribing volumes, thereby impacting sales and revenue potential.

3. Are there any emerging therapeutic developments that could revitalize the market for clorazepate dipotassium?
Currently, no significant innovations are anticipated to rejuvenate its market. Niche uses or niche formulations may offer limited opportunities, but broad market growth remains unlikely.

4. How important are generic versions for the financial trajectory of clorazepate dipotassium?
Generic competition has significantly lowered product prices, eroded profit margins, and contributed to revenue declines, emphasizing the importance of patent expirations on its financial health.

5. What strategic options exist for companies holding patents or formulations of clorazepate dipotassium?
Strategies include repositioning within niche markets, developing specialized formulations, exploring new indications, or gradual portfolio divestment if growth prospects dwindle.

---

Sources

1. U.S. Food and Drug Administration (FDA). Clorazepate Dipotassium Approval & Labeling.
2. MarketsandMarkets. "Global Anxiolytics Market Analysis," 2022.
3. IMS Health. "Trends in Benzodiazepine Prescriptions," 2021.
4. European Medicines Agency (EMA). "Regulatory Status of Benzodiazepines," 2022.
5. World Health Organization (WHO). "Access and Regulation of Psychotropic Medications," 2022.