Temazepam - Generic Drug Details

What are the generic drug sources for temazepam and what is the scope of patent protection?

Temazepam is the generic ingredient in three branded drugs marketed by Specgx Llc, Quantum Pharmics, Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for temazepam. Twenty-two suppliers are listed for this compound.

Summary for temazepam

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	24
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	10
Drug Prices:	Drug price trends for temazepam
Drug Sales Revenues:	Drug sales revenues for temazepam
What excipients (inactive ingredients) are in temazepam?	temazepam excipients list
DailyMed Link:	temazepam at DailyMed

See drug prices for temazepam

See drug sales revenues for temazepam

Recent Clinical Trials for temazepam

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

Sponsor	Phase
Sultan Qaboos University	PHASE4
Turku University Hospital	Phase 4
Saint-Joseph University	Phase 3

See all temazepam clinical trials

Pharmacology for temazepam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for temazepam

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for temazepam

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TEMAZEPAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTORIL	Capsules	temazepam	7.5 mg	018163	1	2006-11-01

US Patents and Regulatory Information for temazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	TEMAZEPAM	temazepam	CAPSULE;ORAL	071446-001	May 21, 1993		DISCN	No	No
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-002	Aug 24, 2023	AB	RX	No	No
Actavis Elizabeth	TEMAZEPAM	temazepam	CAPSULE;ORAL	071620-001	Aug 7, 1987	AB	RX	No	No

Expired US Patents for temazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,030,632
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,211,954
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,326,758

Market Dynamics and Financial Trajectory for Temazepam

Last updated: February 20, 2026

How has the market for temazepam evolved in recent years?

Temazepam, a benzodiazepine primarily used for short-term treatment of insomnia, experienced shifts driven by regulatory developments, prescribing patterns, and the emergence of alternative therapies. Its global market has seen stabilization in developed nations and decline in some regions due to safety concerns.

Regulatory and safety impacts

• In 2013, the U.S. Food and Drug Administration (FDA) issued warnings about dependence and withdrawal risks associated with long-term use of benzodiazepines, including temazepam.
• Several countries (e.g., the UK) reclassified benzodiazepines, leading to reduced prescriptions.
• The European Medicines Agency (EMA) restricts long-term use of benzodiazepines, impacting the growth trajectory.

Prescribing trends

• In the U.S., prescriptions decreased from approximately 25 million in 2010 to 16 million in 2020, reflecting a move toward non-benzodiazepine therapies for sleep disorders.
• In Europe, prescriptions remain steady but show signs of decline amid safety campaigns.

Competition Landscape

• Melatonin, zolpidem, and suvorexant gained popularity.
• Generic versions dominate pricing, pressuring profit margins.

How does the current market size for temazepam compare regionally?

Region	Market Size (USD millions, 2022)	Key Trends
North America	120	Decline in prescriptions; safety concerns drive down demand
Europe	100	Stable but decreasing prescriptions
Asia-Pacific	40	Growing due to increasing sleep disorder diagnoses
Rest of the World	20	Limited use; slower adoption of benzodiazepines

Note: Market sizes are estimates based on IQVIA and industry reports[1].

What financial factors influence temazepam’s market trajectory?

• Patent status: Many formulations are generic, reducing revenue potential.
• Manufacturing costs: Low due to mature production processes.
• Pricing strategies: Competition from generics limits price increases.
• Regulatory costs: Market access costs escalate with increased restriction and surveillance.
• Alternative therapies: Adoption of non-benzodiazepine sleep aids limits growth.

How are generic and branded sales impacted?

• Generic sales account for over 90% of total volume in many regions.
• Branded formulations face steep decline; Pfizer (Lunesta), Sanofi, and Teva are key players behind generics.
• Revenue from branded products is declining faster as generics flood the market.

What are the forecasted financial trends?

Year	Estimated Market Size (USD millions)	Key Trend
2023	160	Slight recovery driven by emerging markets
2025	150	Continued decline in mature markets
2030	130	Market stabilization or further reduction

Projections suggest a gradual decline in developed markets due to safety concerns and substitution by newer sleep aids, but growth in emerging markets offsets this trend temporarily.

What are strategic implications for stakeholders?

• Brand differentiation diminishes; focus shifts to niche markets.
• Opportunities exist in developing new formulations with improved safety profiles.
• Diversification into alternative sleep therapeutics could counteract declines.
• Mergers and acquisitions may target generic portfolios to expand regional market shares.

Key Takeaways

• Temazepam's global market is shrinking in North America and Europe due to safety concerns and evolving prescribing practices.
• Generic versions dominate the market, compressing profit margins for branded producers.
• Emerging markets show potential for growth, driven by increasing sleep disorder diagnoses.
• Regulatory environment greatly influences market size and sales trajectories.
• Investment opportunities may lie in product reformulations or alternative sleep disorder therapies.

FAQs

1. Will temazepam regain market share with new formulations?
Possible if formulations demonstrate improved safety profiles, but regulatory hurdles and existing safety concerns limit rapid market expansion.

2. What regulatory changes could most impact future sales?
Tighter restrictions on prescription durations, mandatory safety warnings, or classification as controlled substances could further reduce prescriptions.

3. Are alternative sleep aids replacing temazepam?
Yes; non-benzodiazepine options like zolpidem and suvorexant are increasingly preferred due to safety profiles.

4. Can emerging markets support growth for temazepam?
Partially; rising sleep disorder awareness may expand use, but affordability and regulatory hurdles remain challenges.

5. What are the key competitive advantages for manufacturers?
Low manufacturing costs and the ability to produce generic formulations support profitability despite declining sales.

References

[1] IQVIA. Global Pharmaceuticals Market Reports. 2022.