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 is one drug master file entry for this compound. Fifteen 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:	36
Clinical Trials:	2
Patent Applications:	4,542
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	085461-001	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	012249-002	Approved Prior to Jan 1, 1982		DISCN	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	4,316,897
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	INJECTABLE;INJECTION	012301-001	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-003	Approved Prior to Jan 1, 1982	4,316,897

Librium Market Dynamics, Patent Status, and Financial Trajectory

Last updated: August 19, 2026

Librium, the brand name for chlordiazepoxide hydrochloride, is a mature benzodiazepine with minimal remaining branded-commercial value. Its patents and regulatory exclusivities expired decades ago, generic chlordiazepoxide dominates supply, and no public company separately reports Librium revenue. Current demand is concentrated in alcohol-withdrawal treatment, anxiety-related indications, and institutional use. The product faces low-cost generic competition, controlled-substance restrictions, clinical substitution by lorazepam and diazepam, and limited promotional investment.

What is Librium and who markets it?

Librium is an oral benzodiazepine containing chlordiazepoxide hydrochloride. Roche introduced it in 1960, making it one of the earliest commercially marketed benzodiazepines. The FDA-approved label covers management of anxiety disorders, short-term relief of anxiety symptoms, acute alcohol withdrawal, and preoperative apprehension, subject to the product labeling and controlled-substance requirements [1].

Attribute	Librium profile
Brand name	Librium
Active ingredient	Chlordiazepoxide hydrochloride
Drug class	Benzodiazepine
Initial U.S. approval	1960
Original developer	Hoffmann-La Roche
Dosage forms	Oral capsules; generic tablets and capsules also marketed
Controlled-substance classification	Schedule IV in the United States
Primary current uses	Alcohol withdrawal, anxiety, selected inpatient protocols
FDA regulatory pathway	Legacy small-molecule NDA and abbreviated generic applications
Current commercial position	Mature, genericized, low-price market
Biosimilar exposure	None

The Librium brand has little strategic importance compared with the generic active ingredient. Manufacturing and distribution are fragmented among generic pharmaceutical companies, wholesalers, hospital suppliers, and retail pharmacies.

When did Librium lose patent and exclusivity protection?

Librium lost meaningful U.S. patent protection many years ago. The product entered the market before the modern Hatch-Waxman framework and before the current Orange Book listing system was established. Any original compound or product patents would have expired by the late twentieth century at the latest.

Protection category	Current status
Original compound protection	Expired
Original formulation protection	Expired
FDA new-drug exclusivity	Expired
Pediatric exclusivity	Not commercially relevant
Orphan-drug exclusivity	None identified
Patent term extension	Not relevant to the current market
Generic approval pathway	ANDA-based competition
Current branded barrier	None of commercial significance

The earliest generic entrants benefited from the ordinary abbreviated approval route. Chlordiazepoxide is now a mature generic active pharmaceutical ingredient with established manufacturing processes and multiple sources of supply.

What is the Orange Book status of Librium?

The Orange Book historically listed Librium and related chlordiazepoxide products under legacy NDA and abbreviated-application records. Orange Book status can change as products are discontinued, withdrawn, or removed from active marketing. The commercial question is not whether historical listings exist, but whether any listed patent or regulatory exclusivity currently blocks an ANDA launch.

No active patent estate is generally recognized as protecting Librium against generic entry. Historical Orange Book entries do not create current exclusivity after patent expiration or product discontinuation. FDA Orange Book records should be distinguished from active commercial availability and from the existence of a current branded manufacturer [2].

The regulatory profile is therefore straightforward:

1. Chlordiazepoxide products can be approved through the generic-drug pathway.
2. No current branded patent is known to delay generic entry.
3. Any remaining listed product information is historical or administrative rather than an effective market barrier.
4. Product discontinuation status does not imply withdrawal for safety or loss of FDA approval across the entire active ingredient category.

How many patents cover Librium?

No commercially material unexpired U.S. patents are known to cover the original Librium product or chlordiazepoxide as a basic active ingredient.

The relevant patent categories are:

Patent category	Librium exposure
Active-ingredient patent	Expired
Salt patent	Expired or commercially irrelevant
Capsule formulation patent	Expired
Extended-release formulation patent	No major current Librium barrier identified
Method-of-use patent	No active exclusivity of commercial significance identified
Manufacturing patent	Process knowledge may remain proprietary, but no brand-blocking patent barrier is apparent
Device or delivery patent	Not applicable to standard oral Librium
Combination-product patent	Not relevant to the core product

Generic manufacturers can still protect manufacturing know-how as trade secrets. That protection differs from a patent and generally does not prevent competitors from producing the same active ingredient through alternative processes.

What is the FDA regulatory status of Librium and generic chlordiazepoxide?

FDA regulation applies to both the branded product and generic chlordiazepoxide products. The principal regulatory constraints are controlled-substance handling, labeling, abuse-risk management, and compliance with current good manufacturing practices.

The FDA label warns about abuse, misuse, addiction, physical dependence, and withdrawal reactions. Benzodiazepines can produce respiratory depression when combined with opioids, alcohol, or other central nervous system depressants [1]. These safety restrictions influence prescribing, pharmacy dispensing, hospital protocols, and payer utilization.

Chlordiazepoxide remains clinically relevant in alcohol withdrawal because of its long half-life and established use in symptom-triggered or fixed-dose protocols. Treatment guidelines commonly identify benzodiazepines as first-line therapy for alcohol withdrawal, although institutional preference may favor diazepam or lorazepam depending on hepatic function, age, severity, and monitoring capacity [3].

What drives current Librium market demand?

Current demand is functional rather than brand-driven. The principal demand segments are:

Alcohol withdrawal treatment

Alcohol withdrawal is the strongest continuing clinical use case. Chlordiazepoxide is used in inpatient and outpatient detoxification protocols, subject to patient selection and monitoring. Demand rises with hospital admissions, detoxification activity, and alcohol-use-disorder treatment volumes.

The product competes with diazepam and lorazepam. Diazepam has a similarly long duration of action, while lorazepam is often preferred in patients with significant hepatic impairment or in settings requiring more predictable metabolism.

Anxiety treatment

Anxiety remains an FDA-labeled indication, but Librium has lost share to newer therapies. Selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, buspirone, psychotherapy, and newer prescribing norms have reduced chronic benzodiazepine use. Short-term benzodiazepine prescribing remains relevant, but Librium is not a leading branded option.

Perioperative and institutional use

Chlordiazepoxide may be used in selected hospital protocols, but utilization is limited by formulary policy, sedation risk, fall risk, dependence concerns, and the availability of alternative agents.

Generic substitution

Pharmacy-level substitution is the central market mechanism. Prescriptions written for chlordiazepoxide are typically filled with a generic product unless a brand-specific requirement applies. This sharply limits brand pricing power.

How does Librium compare with competing benzodiazepines?

Product	Main competitive use	Commercial position	Relative Librium effect
Chlordiazepoxide	Alcohol withdrawal, anxiety	Mature generic	Reference product
Diazepam	Alcohol withdrawal, muscle spasm, seizure rescue, anxiety	Large generic market	Strong substitute
Lorazepam	Alcohol withdrawal, anxiety, seizures, procedural use	Large generic and hospital market	Strong substitute
Oxazepam	Alcohol withdrawal, anxiety	Generic, often selected for hepatic considerations	Niche substitute
Alprazolam	Anxiety and panic disorder	Large generic market	Competes mainly in outpatient anxiety
Clonazepam	Panic disorder and seizure disorders	Large generic market	Competes in chronic outpatient use

Librium’s competitive position is strongest where clinicians value a long-acting benzodiazepine for alcohol withdrawal. Its position is weaker in general anxiety treatment, where other benzodiazepines and non-benzodiazepine therapies have broader prescribing momentum.

What is the financial trajectory of Librium?

Librium’s financial trajectory follows the standard pattern for an old small-molecule drug:

1. High initial value after launch and clinical adoption.
2. Declining branded revenue after patent expiry.
3. Rapid price compression following generic entry.
4. Fragmented low-margin generic supply.
5. Stable but limited demand from established clinical protocols.

No major pharmaceutical company publicly reports standalone Librium revenue in current filings. The brand’s sales, if any remain, are immaterial relative to the reporting companies’ consolidated results. Generic chlordiazepoxide revenue is also generally embedded within broader portfolios of controlled substances, central nervous system products, or hospital generics.

Financial driver	Current effect
Patent expiry	Eliminated premium pricing
Generic competition	Compresses price and gross margin
Brand recognition	Limited value without exclusivity
Alcohol-withdrawal demand	Supports baseline volume
Anxiety prescribing trends	Long-term demand pressure
Controlled-substance compliance	Raises operating costs
Hospital purchasing	Increases price sensitivity
Shortages or supplier exits	Can create temporary price increases
Promotional investment	Low
Licensing value	Low absent a differentiated formulation

The relevant commercial metric is likely volume and supply reliability rather than brand revenue. A manufacturer with an efficient API source, reliable FDA-compliant production, and established hospital or wholesaler contracts can generate steady but modest returns. A branded relaunch would face weak pricing power unless it added a differentiated delivery system, abuse-deterrent feature, or clinically meaningful formulation.

What generic entry risks exist for Librium?

Generic-entry risk is effectively realized rather than prospective. Chlordiazepoxide has been generic for decades. The current risks concern additional generic competition and supply economics.

Price erosion

Multiple suppliers can trigger low prices, especially for common capsule strengths. Contracting organizations and pharmacy benefit managers generally treat chlordiazepoxide as a commodity product.

Manufacturing concentration

Although several suppliers may hold approvals, actual active pharmaceutical ingredient production can be concentrated geographically or among a small number of qualified manufacturers. A plant shutdown, quality warning letter, import restriction, or API shortage can temporarily affect availability.

Substitution risk

Demand can shift away from chlordiazepoxide toward diazepam or lorazepam. Hospitals can revise protocols quickly when pricing, availability, or safety considerations change.

Controlled-substance compliance

Manufacturers and distributors must comply with DEA registration, quota and inventory controls, recordkeeping, suspicious-order monitoring, and state-level requirements. These obligations increase compliance costs and can discourage smaller suppliers [4].

Are there formulation or method-of-use patents protecting Librium?

No active formulation or method-of-use patent is known to create a material barrier around standard oral Librium or generic chlordiazepoxide.

Potential technical differentiation could include:

• Modified-release oral dosage forms.
• Abuse-deterrent formulations.
• Combination products for structured alcohol-withdrawal protocols.
• Alternative delivery systems.
• Lower-sedation or pharmacokinetically optimized formulations.

These concepts would require new patent filings and FDA approval. They would not restore exclusivity to legacy Librium. A reformulated product could qualify for new patent protection if it met novelty and non-obviousness requirements, but commercial success would depend on clinical differentiation and payer acceptance.

Which companies are challenging or competing with Librium?

The competitive field consists of generic manufacturers rather than patent challengers. Publicly visible competitors can include companies that market chlordiazepoxide capsules or tablets under ANDAs, along with manufacturers of alternative benzodiazepines.

The most important competitive groups are:

• Generic chlordiazepoxide manufacturers.
• Diazepam suppliers.
• Lorazepam suppliers.
• Oxazepam suppliers.
• Hospital-focused generic manufacturers.
• Contract manufacturers and API suppliers.

A traditional Paragraph IV litigation event is unlikely to be commercially relevant for the legacy Librium product because no current brand patent is known to block generic entry. Paragraph IV certifications matter when an ANDA applicant challenges an unexpired listed patent. That framework does not create an obstacle where the relevant patents have already expired or no longer have effective scope [5].

What patent litigation affects Librium?

No major active U.S. patent litigation is generally associated with the legacy Librium product. The absence of litigation reflects the age of the product and the lack of a current patent-based launch barrier.

Potential legal exposure is more likely to arise from:

• FDA manufacturing compliance.
• Controlled-substance distribution.
• Product liability.
• Labeling and failure-to-warn claims.
• Diversion and suspicious-order investigations.
• Contract disputes among generic suppliers.

These issues differ from patent litigation and do not provide a mechanism for restoring exclusivity.

Are there Librium licensing deals?

No major recent licensing transaction centered on legacy Librium is publicly prominent. The original product was associated with Roche, but its current economic value is not comparable to an actively promoted patented medicine.

Licensing interest could arise for:

• A new chlordiazepoxide formulation.
• A hospital alcohol-withdrawal platform.
• A controlled-release product.
• A combination therapy.
• A regional commercialization agreement.

Without a new formulation, clinical claim, or manufacturing advantage, the licensing value of standard Librium is low. Buyers would generally prioritize supply reliability, regulatory history, cost, and distribution access over brand ownership.

What is the geographic coverage of Librium?

Chlordiazepoxide has broad international recognition and is marketed in multiple jurisdictions under brand and generic names. However, commercial availability differs by country because of:

• National controlled-substance rules.
• Local generic registration.
• Reimbursement policy.
• Hospital formularies.
• Import and API controls.
• National treatment guidelines.

U.S. demand is shaped by FDA and DEA requirements. European and other markets apply separate marketing-authorization and controlled-drug rules. Geographic brand rights are therefore less important than local generic approvals, distributor relationships, and compliance infrastructure.

How strong is the Librium patent estate?

The Librium patent estate is commercially weak because the original exclusivity period has ended and no meaningful current patent moat is apparent.

Patent-strength factor	Assessment
Core molecule protection	None currently effective
Formulation protection	No material legacy barrier
Method-of-use protection	No material legacy barrier
Manufacturing protection	Possible trade secrets, limited patent moat
Regulatory exclusivity	Expired
Generic barriers	Low
Brand pricing power	Minimal
Relevance to licensing	Low
Litigation leverage	Low

The product can still have operational value even without patent strength. A supplier with reliable production, low defect rates, and strong distribution can retain market share. That is a manufacturing and commercial advantage, not an exclusivity advantage.

What generic launch scenarios are relevant?

Because generic entry has already occurred, the likely scenarios concern market reconfiguration:

Base case: stable low-margin supply

Demand remains steady in alcohol-withdrawal protocols, while generic prices remain low. Suppliers compete on cost, availability, and quality compliance.

Supply-contraction case

One or more manufacturers exit, experience an FDA quality issue, or lose API access. Remaining suppliers may obtain temporary pricing leverage, but substitutes can limit the duration of any increase.

Substitution case

Hospitals move toward diazepam or lorazepam because of formulary preferences, clinical protocols, or supply concerns. Chlordiazepoxide volume declines without a corresponding patent event.

Reformulation case

A company develops a clinically differentiated formulation. The opportunity would depend on new patents, FDA approval, abuse-deterrence value, and reimbursement. Standard Librium economics would not automatically transfer to the new product.

Key Takeaways

• Librium is chlordiazepoxide hydrochloride, a benzodiazepine introduced by Roche in 1960.
• Original patents and regulatory exclusivities expired decades ago.
• Generic chlordiazepoxide dominates the market.
• No active patent estate is known to create a meaningful barrier to generic competition.
• Current demand is concentrated in alcohol-withdrawal treatment and selected institutional use.
• Diazepam and lorazepam are the principal clinical substitutes.
• No standalone Librium revenue is publicly disclosed by major pharmaceutical companies.
• Financial value is tied to generic volume, manufacturing reliability, and distribution rather than brand pricing.
• Paragraph IV litigation and patent settlements are not central current risks.
• The most relevant business risks are price erosion, supply disruption, controlled-substance compliance, and therapeutic substitution.
• A new formulation could create patent value, but legacy Librium itself has limited licensing or investment appeal.

FAQs About Librium Market and Patent Status

Is Librium still sold in the United States?

Generic chlordiazepoxide remains available, although brand availability and product status can vary by manufacturer and distributor. Pharmacies commonly dispense generic chlordiazepoxide rather than branded Librium.

Does Librium have an active Orange Book patent?

No commercially meaningful unexpired patent is generally recognized as blocking generic chlordiazepoxide entry. Historical Orange Book records should not be treated as evidence of current brand exclusivity.

Can a company launch a generic version of Librium without a patent challenge?

Yes. Where relevant patents have expired or no longer block approval, an ANDA applicant does not need to create a current Paragraph IV litigation event to enter the market.

Is Librium a biosimilar or biologic product?

No. Librium is a conventional small-molecule drug. Biosimilar regulation does not apply.

Could a new chlordiazepoxide product receive new patent protection?

Possibly, if it contains a genuinely novel and non-obvious formulation, delivery system, manufacturing process, or approved use. New protection would apply to the improved product, not to the expired Librium molecule itself.

References

1. U.S. Food and Drug Administration. (2020). Librium (chlordiazepoxide hydrochloride) capsules: Prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. American Society of Addiction Medicine. (2020). The ASAM clinical practice guideline on alcohol withdrawal management. Journal of Addiction Medicine, 14(3S Suppl 1), 1-72.
4. U.S. Drug Enforcement Administration. (2024). Drug scheduling and controlled-substance requirements.
5. U.S. Food and Drug Administration. (2018). Abbreviated new drug application submissions: Refuse-to-receive standards.