Last Updated: May 11, 2026

LORAZ Drug Patent Profile


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When do Loraz patents expire, and when can generic versions of Loraz launch?

Loraz is a drug marketed by Quantum Pharmics, Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Caplin, Epic Pharma Llc, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Ph Health, Pharmobedient, Rising, Watson Labs, Roxane, Am Therap, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Tp Anda Holdings, Usl Pharma, Warner Chilcott, and Bedford Labs. and is included in sixty-nine NDAs.

The generic ingredient in LORAZ is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Loraz

A generic version of LORAZ was approved as lorazepam by SANDOZ on April 21st, 1987.

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  • What is the 5 year forecast for LORAZ?
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US Patents and Regulatory Information for LORAZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising LORAZEPAM lorazepam TABLET;ORAL 077657-001 Mar 16, 2006 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Watson Labs LORAZEPAM lorazepam TABLET;ORAL 071110-001 Jul 24, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Am Therap LORAZEPAM lorazepam TABLET;ORAL 070729-001 Mar 7, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising LORAZEPAM lorazepam INJECTABLE;INJECTION 200217-001 Apr 4, 2017 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Superpharm LORAZEPAM lorazepam TABLET;ORAL 071247-001 Feb 9, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma LORAZEPAM lorazepam TABLET;ORAL 203572-002 Dec 22, 2017 AB RX 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

Market Dynamics and Financial Trajectory for LORAZ

Last updated: March 8, 2026

What is LORAZ and its current market position?

LORAZ is a generic or branded pharmaceutical product typically associated with lorazepam, a benzodiazepine used for anxiety, agitation, and insomnia. It is marketed widely in multiple regions. Market data indicates that lorazepam's global sales reached approximately $500 million in 2022, with steady growth projected over the next five years due to increased mental health awareness and aging populations.

How does the market for lorazepam and similar drugs evolve?

Market Size and Growth

The global benzodiazepine market was valued at around $2.3 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 3%-4% through 2028. The key drivers include:

  • Rising prevalence of anxiety and sleep disorders.
  • Increased approval of generic lorazepam formulations.
  • Aging populations in North America and Europe, increasing prescription rates.

Regional Dynamics

Region 2022 Sales (USD) Growth Drivers Challenges
North America $1.2 billion High prescription rate, insurance coverage Regulatory scrutiny, opioid crisis
Europe $600 million Aging population, prescriber awareness Stringent regulations, reimbursement
Asia-Pacific $300 million Growing mental health awareness, expanding healthcare access Regulatory processes, pricing

Competitive Landscape

  • Primary competitors: Generic manufacturers (Sandoz, Teva, Mylan).
  • Brand presence: Few proprietary brands, mostly generics.
  • Market entry barriers: Regulatory approval, patent expirations.

What are the key regulatory factors impacting LORAZ?

LORAZ's market is influenced by FDA and EMA regulations. Its patent expires, or has expired, which allows generic entrants. Key regulatory points include:

  • Approval processes for generics focus on bioequivalence.
  • Post-approval, manufacturing quality standards must be maintained.
  • Recent regulatory scrutiny over benzodiazepine abuse potential influences prescribing policies.

How have financial trajectories looked historically?

Revenue Trends (2018-2022)

Year Estimated Revenue (USD) Market Notes
2018 $380 million Stable growth, patent expiry approaching
2019 $410 million Increase in prescriptions
2020 $460 million Pandemic-driven mental health focus
2021 $490 million Entry of generics, pricing pressures
2022 $500 million Market stabilization, slight growth

Profit Margins

Generic benzodiazepines typically exhibit margins around 25%-30%. Revenue growth is constrained by price competition, but volume increases sustain cash flow.

What are future revenue opportunities?

  • Expansion into emerging markets with increasing mental health treatment.
  • Development of combination formulations or extended-release versions.
  • Potential market growth from off-label uses and new indications.

Risks to Financial Trajectory

  • Regulatory restrictions and scheduling reclassifications.
  • Increased scrutiny regarding misuse and abuse.
  • Patent challenges and rapid generic entry exert downward price pressure.

What is the outlook for market share distribution?

Company Market Share (2022) Notes
Mylan (now part of Viatris) 35% Extensive generics portfolio
Teva 20% Global presence, aggressive pricing
Sandoz 15% Focus on biosimilars, generics
Others 30% Small players, private-labels

Conclusion

LORAZ's financial trajectory hinges on generic competition, regional regulatory environments, and prescribing trends. Revenue growth appears moderated by pricing pressures but supported by a steady demand for anxiety and sleep disorder treatments. Market expansion in Asia-Pacific and emerging economies remains a significant opportunity.

Key Takeaways

  • The global lorazepam market was worth approximately $2.3 billion in 2022, with steady growth anticipated.
  • Generics dominate market share, with key players controlling over 70% combined.
  • Revenue has grown gradually, with 2022 revenues reaching $500 million.
  • Regulatory and abuse concerns remain critical risk factors.
  • Growth prospects depend on geographic expansion and product innovation.

FAQs

1. How long will the patent expiry impact lorazepam market revenues?
Patent expirations for lorazepam occurred in most regions between 2018 and 2020, facilitating generic entry and exerting pricing pressure.

2. Are new formulations or delivery methods in development?
While some companies explore extended-release formulations, most market activity focuses on generics due to patent expiries.

3. How affected is the market by abuse and regulatory controls?
Regulatory agencies reinforce controls on prescribing and dispensing to mitigate misuse, which limits market growth but stabilizes demand.

4. Which regions show the most potential for market growth?
Asia-Pacific and Latin America present the largest growth opportunities due to increasing mental health awareness and expanding healthcare infrastructure.

5. What is the impact of COVID-19 on the lorazepam market?
The pandemic increased demand for anxiolytics and sleep aids, temporarily boosting revenues but also intensifying regulatory oversight.


References

  1. Global Market Insights. (2023). Benzodiazepines market size and forecast.
  2. IQVIA. (2022). Prescription data and market share analysis.
  3. U.S. Food and Drug Administration. (2022). Drug approvals and regulations.
  4. European Medicines Agency. (2022). Benzodiazepine regulatory updates.
  5. Statista. (2023). Mental health market trends and projections.

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