Last Updated: May 3, 2026

TEMAZ Drug Patent Profile


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When do Temaz patents expire, and what generic alternatives are available?

Temaz is a drug marketed by 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-three NDAs.

The generic ingredient in TEMAZ is temazepam. There are seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the temazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Temaz

A generic version of TEMAZ was approved as temazepam by NOVEL LABS INC on April 21st, 1987.

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Summary for TEMAZ
US Patents:0
Applicants:13
NDAs:23

US Patents and Regulatory Information for TEMAZ

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 070384-001 Mar 23, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-004 Jun 4, 2015 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novel Labs Inc TEMAZEPAM temazepam CAPSULE;ORAL 071457-001 Apr 21, 1987 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 078581-001 Sep 8, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TEMAZ Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Investment Scenario for TEMAZ?

TEMAZ (Temazepam) is a benzodiazepine used for short-term treatment of insomnia and sleep disturbances. Its market prospects depend on patent status, regulatory environment, clinical advantages, and competitive landscape.

Market Size and Outlook

  • The global sleep aid market, valued at approximately $67 billion in 2022, is projected to grow at a CAGR of 6.5% through 2028 [1].

  • Temazepam accounts for an estimated 10-15% of benzodiazepine prescriptions in North America and Europe [2].

  • Rising prevalence of insomnia, especially among aging populations, sustains demand.

Regulatory and Patent Status

  • TEMAZ was developed decades ago; most formulations are off-patent.

  • Some markets have generic versions with significant price erosion.

  • Few recent patents or formulations protect TEMAZ, limiting exclusivity and profit margins.

Competitive Landscape

  • Generic benzodiazepines (e.g., diazepam, lorazepam) compete with TEMAZ on efficacy and cost.

  • Newer sleep agents (e.g., non-benzodiazepine Z-drugs, melatonin receptor agonists) challenge market share.

  • The drug's safety profile and potential for dependence pose limitations.

What Are the Fundamentals of TEMAZ?

Pharmacology and Efficacy

  • Acts as a GABA_A receptor agonist, increasing chloride ion influx, leading to sedative effects.

  • Onset of sleep: 15-30 minutes; duration: 6-8 hours.

  • Effective for short-term insomnia management.

Safety Profile and Risks

  • Common side effects include drowsiness, dizziness, and cognitive impairment.

  • Risks of dependence, tolerance, and withdrawal syndrome.

  • Not recommended for long-term use by current guidelines.

Clinical Trials and Data

  • Multiple studies demonstrate efficacy in reducing sleep latency and increasing sleep duration [3].

  • Some evidence suggests increased risk of falls and cognitive decline in elderly users.

  • No recent major clinical trials or comparative studies for TEMAZ.

Pricing and Reimbursement

  • Prices vary globally; generic versions are significantly cheaper than branded.

  • Reimbursement policies favor cost-effective options.

  • Limited incentives for pharmaceutical companies to invest in new TEMAZ formulations.

Manufacturing and Supply Chain

  • Established manufacturing processes.

  • Generic producers dominate supply.

  • Recent supply chain disruptions are minimal.

What Are the Investment Risks and Opportunities?

Risks

  • Patent expiration diminishes exclusive profit potential.

  • Growing preference for non-benzodiazepine sleep agents.

  • Regulatory restrictions due to safety concerns.

  • Market competition from branded and generic alternatives.

Opportunities

  • Development of abuse-deterrent formulations.

  • Indications expansion into other sleep-related disorders.

  • Differentiation through improved safety or convenience.

  • Entry into emerging markets with unmet demand.

What Is the Overall Investment Outlook?

The outlook for TEMAZ as an investment is limited without new formulation or indication innovations. Market saturation and regulatory concerns curtail growth prospects. Entry barriers remain low due to patent expirations and generic competition. Companies with existing market share or pipeline innovation may find incremental opportunities, but large-scale profitable expansion appears constrained.

Key Takeaways

  • TEMAZ is an established, short-term treatment for insomnia with declining proprietary advantages.

  • Market growth is driven by aging populations and sleep disorder prevalence, but faces competition from newer agents.

  • Limited patent protection and safety concerns restrict long-term revenue potential.

  • Opportunities exist in formulation innovation and emerging markets, though investments carry significant risks.

  • Competitive pressure from generics and alternative therapies necessitates strategic positioning.

FAQs

1. Why has TEMAZ seen declining sales in recent years?

Patent expirations, increasing availability of cheaper generics, and the rise of non-benzodiazepine sleep agents reduce its market share.

2. Are there new formulations of TEMAZ under development?

No significant new TEMAZ formulations are reported, though some companies explore abuse-deterrent or extended-release versions.

3. How does TEMAZ compare to other insomnia medications?

It has similar efficacy but more safety concerns, especially regarding dependence and cognitive effects, versus newer, non-benzodiazepine agents.

4. What regulatory challenges does TEMAZ face?

Safety concerns about dependency and misuse contribute to tighter prescribing guidelines and potential restrictions in some markets.

5. Is there potential for TEMAZ in indications beyond insomnia?

Limited; current evidence does not support expansion into other indications, and safety issues restrict off-label use.


Sources

[1] MarketWatch, "Global Sleep Aids Market," 2022.
[2] IMS Health, "Benzodiazepine Prescription Trends," 2021.
[3] Cochrane Database, "Efficacy of Temazepam in Insomnia," 2019.

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