LIBRIUM Drug Patent Profile

Which patents cover Librium, and when can generic versions of Librium launch?

Librium is a drug marketed by Bausch and Valeant Pharm Intl and is included in five NDAs.

The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Librium

A generic version of LIBRIUM was approved as chlordiazepoxide hydrochloride by CHARTWELL RX on December 31^st, 1969.

Summary for LIBRIUM

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	7,156
DailyMed Link:	LIBRIUM at DailyMed

Recent Clinical Trials for LIBRIUM

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

Sponsor	Phase
University of Bristol	Phase 4
VA Salt Lake City Health Care System	Phase 4

See all LIBRIUM clinical trials

Pharmacology for LIBRIUM

Drug Class

Benzodiazepine

US Patents and Regulatory Information for LIBRIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085475-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	INJECTABLE;INJECTION	012301-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085472-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085461-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for LIBRIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-002	Approved Prior to Jan 1, 1982
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-001	Approved Prior to Jan 1, 1982
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	INJECTABLE;INJECTION	012301-001	Approved Prior to Jan 1, 1982
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-003	Approved Prior to Jan 1, 1982

Summary
Librium (chlordiazepoxide) remains a historically significant benzodiazepine but has seen limited use compared to newer anxiolytics. Its market is constrained by regulatory scrutiny and competition from alternative therapies. Financial prospects are modest, with steady but declining revenues driven primarily by legacy markets. The drug's safety profile and evolving treatment guidelines influence its sales and market dynamics.

Market Overview
Librium was first approved in 1960 by the FDA for anxiety and alcohol withdrawal syndromes. It was among the earliest benzodiazepines, establishing itself as a treatment option for short-term anxiety relief and detoxification protocols.

Market Penetration and Usage

• Historical dominance: During the 1960s-1980s, Librium held a significant share in the antianxiety medication market.
• Shift in prescribing patterns: A move towards safer, non-benzodiazepine medications, such as SSRIs, and concerns over dependency have reduced its prescribing rates.
• Current indications: Primarily used in alcohol withdrawal management; off-label and legacy use persists in certain settings.

Market Size and Revenue

• Global sales: Estimated at approximately $50-$100 million annually as of 2022, reflecting a decline from peak sales of over $300 million in the 1970s (per IMS Health [1]).
• Major markets: United States, Europe, and select Asian countries.
• Market share: Benzodiazepines account for roughly 20% of anxiolytic prescriptions in the U.S., with Librium contributing a small but steady portion.

Competitive Landscape

• Alternatives: Diazepam (Valium), lorazepam (Ativan), and newer non-benzodiazepine anxiolytics have taken market share.
• Safety concerns: Dependency potential and adverse effects constrain prescribing practices.
• Regulatory shifts: Increased oversight and Prescription Drug Monitoring Programs (PDMPs) limit misuse and over-prescription.

Regulatory and Policy Environment

• Stringent guidelines for benzodiazepine prescriptions, especially in the US and Europe.
• Growing emphasis on alternative treatments and non-pharmacologic therapies for anxiety disorders.
• No recent FDA approvals or reformulations for Librium have been announced; existing approvals are over five decades old.

Financial Projections

• Revenue trajectory: Projected slight decline at a CAGR of -2% to -4% over the next five years, reflecting the aging product and declining prescriptions.
• Profitability: Margins are stable but limited; manufacturing costs are low, but sales volume reduction impacts top-line revenue.
• Market drivers: Continued use in alcohol withdrawal protocols and legacy coverage in certain regions sustain revenues.

Potential Market Drivers and Risks

• Drivers: Stable demand in alcohol detox markets, long-standing formulary positioning, and ongoing medical applications.
• Risks: Regulatory tightening, generic competition, and decreased clinical use could further depress sales.

Competitive Advantages and Limitations

• Advantages: Patent exclusivity expired decades ago, but its established safety profile in specific indications remains relevant.
• Limitations: Older molecule with less appeal for new drug development, shrinking market segment, and competition from newer, safer anxiolytics.

Key Takeaways
Librium's market is characterized by limited growth, steady decline, and competitive pressure. Its use is primarily in alcohol withdrawal, with prescription trends influenced by safety concerns and alternative therapies. Despite a loyal niche, the outlook remains subdued, with revenues expected to decline gradually over the coming years. The drug's legacy status limits significant upside potential, but its established role in specific indications sustains its presence.

FAQs

Last updated: February 8, 2026

1. Is Librium still under patent protection?
   No. Librium's patent expired in the 1970s. It is marketed as a generic drug globally.

2. What factors most significantly impact Librium's market?
   Regulatory restrictions, competition from newer medications, and shifts in prescribing patterns impact its sales.

3. Are there ongoing efforts to reformulate or repurpose Librium?
   No significant reformulation efforts are publicly documented; the focus remains on its established indications.

4. What is the primary use for Librium today?
   Screening in alcohol withdrawal management remains its mainstay usage.

5. Could Librium regain market share?
   Unlikely, given the availability of newer, safer alternatives and regulatory pressures.

References
[1] IMS Health Data. Market trends and sales figures for benzodiazepines, 2022.