ATIVAN Drug Patent Profile

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

Ativan is a drug marketed by Hikma and Bausch and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ativan

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

Summary for ATIVAN

US Patents:	0
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for ATIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

International Patents for ATIVAN

See the table below for patents covering ATIVAN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	461715
Germany	2302659
United Kingdom	1345510
France	2181679
Ireland	38298	PARENTERAL BENZODIAZEPINE COMPOSITIONS

Investment Scenario and Fundamentals Analysis for ATIVAN (Lorazepam)

Last updated: February 3, 2026

Overview of ATIVAN as an Investment Asset

ATIVAN (generic name: lorazepam) is a benzodiazepine used for anxiety, insomnia, and preoperative sedation. Marketed primarily through Pfizer, its patent has expired, leading to extensive generic competition. Although it commands a mature market position, patent expiry and competitive pressures influence its investment profile.

Market Dynamics and Revenue Outlook

• Market Size & Growth: The global benzodiazepine market was valued at approximately $700 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 3-5% through 2030 [1]. The growth is driven by increased diagnoses of anxiety disorders and shifts toward outpatient, prescription-based treatments.

• Generic Competition: With patent expiry, multiple generic manufacturers produce lorazepam. Pfizer's branded ATIVAN accounts for less than 10% of the market share, with generics dominating. Price erosion pressures impact profitability.

• Pricing Trends: Average wholesale prices for lorazepam generics have declined by roughly 20% over the last five years [2]. Price competition intensifies as more generics enter the market, further compressing margins.

Regulatory & Patent Position

• Patent Status: The original patent on lorazepam expired around 2012. No exclusivity rights currently protect ATIVAN specifically, leaving the product vulnerable to commoditization.

• Regulatory Considerations: Manufacturing and distribution require compliance with the FDA's regulations. Risk of regulatory action is low but exists, particularly with concerns over controlled substances regulation or formulation quality.

Supply Chain and Manufacturing

• Manufacturing Risks: The active pharmaceutical ingredient (API) for lorazepam is sourced from multiple suppliers. Disruption of API supply can impair production, risking revenue loss and reputational damage.

• Manufacturing Costs: The cost structure for generic lorazepam is low, with APIs costing around $0.05 per tablet, enabling high margins even at low prices.

Profitability and Cost Structure

• Margins: Gross margins for generic benzodiazepines typically range from 25-35%. Operating costs are minimized due to high-volume, streamlined manufacturing. Price declines may erode margins, unless production costs decrease further.

• Pricing Sensitivity: Small price reductions lead to significant volume-driven revenue changes. The elasticity of demand depends on prescriber and payer preferences, with increased use on formulary lists.

Legal & Ethical Risks

• Controlled Substance Regulation: As a Schedule IV controlled substance, lorazepam faces strict prescribing and distribution controls. Non-compliance risks include fines and loss of license.

• Litigation Risks: Although low, potential lawsuits from misuse or adverse effects could impact brand reputation and legal costs.

Competitive Landscape

Competitors	Market Share	Price Position	Key Differentiator
Multiple generics	85-95%	Similar low prices	Differentiation based on formulation quality and manufacturing volume
Alternative anxiolytics	Limited	Varies	Use of non-benzodiazepine medication avoid regulatory restrictions

Investment Risks and Opportunities

• Risks:

  • Price erosion due to increased generic competition.
  • Regulatory changes affecting controlled substance scheduling.
  • Supply chain and manufacturing disruptions.

• Opportunities:

  • Potential for biosimilar or alternative formulations.
  • Expansion into emerging markets where benzodiazepine use grows.
  • Contract manufacturing services for other generic APIs.

Financial Metrics and Investment Considerations

Metric	Value / Trend	Implication
Revenue	Declined marginally over past 3 years due to price competition	Sales volume stabilizes amid price erosion
EBITDA Margin	Estimated 20-25% for generic products	Margins are compressed but still attractive
R&D Investment	Minimal	Focus on manufacturing efficiency rather than innovation
Market Penetration	Saturated in mature markets	Growth depends on market expansion and acceptance

Conclusion

Investing in ATIVAN as a branded product offers limited upside due to patent expiry and rising generics production. Focus should be on supply chain stability, cost control, and expansion into markets with limited competition. The key driver remains price competition in a highly commoditized market sector.

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Key Takeaways

• ATIVAN's revenue depends on generics market share and pricing trends.
• Patent expiry has shifted profits to low-cost generics; margins are compressed.
• The product faces legal and regulatory risks linked to controlled substance status.
• Market growth opportunities are primarily in emerging markets or alternative formulations.
• Supply chain stability and cost efficiency are vital for ongoing profitability.

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Frequently Asked Questions

1. What is the primary factor impacting ATIVAN’s profitability?
Price erosion due to intense generic competition reduces margins, especially as multiple manufacturers produce lorazepam.

2. How does patent expiry affect ATIVAN’s market dynamics?
It opens the market to low-cost generics, diminishing the branded drug’s market share and profitability.

3. Are there regulatory risks specific to ATIVAN?
Yes, as a Schedule IV controlled substance, regulatory scrutiny and compliance are critical and carry compliance risks.

4. Is there growth potential in ATIVAN’s market?
Growth is limited in mature markets but could expand through emerging markets or new formulations.

5. What strategic considerations should investors monitor?
Supply chain stability, competitive pricing trends, regulatory developments, and potential market expansion opportunities.

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References

[1] MarketsandMarkets, "Benzodiazepine Market," 2022.
[2] IQVIA, "Pharmaceutical Pricing Trends," 2021.