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Last Updated: December 22, 2024

XANAX XR Drug Patent Profile


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Which patents cover Xanax Xr, and what generic alternatives are available?

Xanax Xr is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in XANAX XR is alprazolam. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xanax Xr

A generic version of XANAX XR was approved as alprazolam by NOVITIUM PHARMA on October 19th, 1993.

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Drug patent expirations by year for XANAX XR
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Pharmacology for XANAX XR
Drug ClassBenzodiazepine

US Patents and Regulatory Information for XANAX XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-002 Jan 17, 2003 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-003 Jan 17, 2003 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for XANAX XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003 5,061,494 ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003 5,061,494 ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-003 Jan 17, 2003 5,061,494 ⤷  Subscribe
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-002 Jan 17, 2003 5,061,494 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

XANAX XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XANAX XR

Introduction to XANAX XR

XANAX XR, the extended-release version of alprazolam, is a benzodiazepine commonly used for the treatment of panic disorder, with or without agoraphobia. Understanding its market dynamics and financial trajectory is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global benzodiazepine drugs market, which includes XANAX XR, is projected to experience steady growth. As of 2022, the market was valued at US$ 2.35 billion and is expected to reach US$ 3.1 billion by 2032, growing at a compound annual growth rate (CAGR) of 2.8%[2][4].

Segment Analysis

Within the benzodiazepine market, alprazolam, the active ingredient in XANAX XR, holds a significant share. Alprazolam is expected to account for 29.6% of the market share and expand at a CAGR of 2.9% during the forecast period[2][4].

Regional Market Performance

North America, particularly the United States, is a dominant region for the benzodiazepine drugs market, including XANAX XR. This is due to the high prevalence of anxiety disorders and the increased number of FDA approvals for benzodiazepine drugs. The U.S. market is expected to expand at a CAGR of 2.1% during the forecast period[2][4].

Drivers of Market Growth

Several factors drive the growth of the benzodiazepine market, including:

Increasing Prevalence of Anxiety Disorders

The rise in anxiety-related disorders is a significant driver. According to the Anxiety and Depression Association of America (ADAA), around 40 million adults in the United States are affected by anxiety disorders each year, with only 36.9% seeking treatment[2][4].

Urbanization and Work Culture

Speedy urbanization and the current work culture have increased mental health issues, creating a substantial growth opportunity for benzodiazepine drugs[2].

Healthcare R&D and FDA Approvals

Investments in healthcare research and development, along with increased FDA approvals for new benzodiazepine drugs, are also driving market growth. For instance, the FDA approval of Loreev XR in 2021 has contributed to market expansion[2].

Efficacy and Publication Bias

Recent studies have raised questions about the efficacy of XANAX XR. A report by researchers from Oregon Health & Science University School of Medicine and Harvard Medical School found that publication bias in medical journals may have inflated the effectiveness of XANAX XR for panic disorder by more than 40%. The study analyzed FDA data from phase 2 and 3 clinical trials and found that only one in five trials had a clearly positive outcome, indicating that the actual efficacy of XANAX XR might be lower than previously reported[1].

Adverse Reactions and Dependence

The use of XANAX XR is associated with several adverse reactions and the risk of physical dependence. In clinical trials, approximately 17% of patients who received XANAX XR experienced adverse events leading to discontinuation, compared to 8% of placebo-treated patients. Common adverse reactions include sedation, somnolence, dysarthria, and coordination abnormalities[3].

Financial Implications

Given the market dynamics, the financial trajectory for XANAX XR is influenced by several factors:

Market Share

As a significant segment within the benzodiazepine market, XANAX XR benefits from the overall market growth. However, the potential overestimation of its efficacy could impact its long-term market share and revenue.

Prescription Trends

The increasing prescriptions for benzodiazepine drugs, particularly for anxiety disorders, contribute to the financial growth of XANAX XR. However, the need for novel drugs with minimal side effects and the rise of generic alternatives could affect its market position[2][4].

Regulatory Environment

FDA approvals and regulatory support are crucial for the financial success of XANAX XR. Continued approvals and positive regulatory outcomes will help maintain its market presence[2].

Long-Term Outlook

Short Term (2022 to 2025)

The rising use of benzodiazepine drugs for mental disorders will favorably affect the market growth of XANAX XR. Increased awareness and diagnosis of anxiety disorders will drive prescriptions and revenue[2].

Medium Term (2025 to 2028)

Product development with minimal side effects will be critical. As new drugs with better safety profiles enter the market, XANAX XR may face competition, but its established brand and existing market share will help it maintain a significant position[2].

Long Term (2028 to 2032)

Rising urbanization and extraordinary work pressure will continue to drive the demand for benzodiazepine drugs. However, the long-term efficacy and safety concerns, along with potential regulatory changes, will need to be addressed to sustain market growth[2].

Key Takeaways

  • The global benzodiazepine drugs market, including XANAX XR, is expected to grow at a CAGR of 2.8% to reach US$ 3.1 billion by 2032.
  • Alprazolam, the active ingredient in XANAX XR, holds a significant market share and is projected to expand at a CAGR of 2.9%.
  • North America, particularly the U.S., is a dominant market due to high anxiety disorder prevalence and FDA approvals.
  • Publication bias may have inflated the efficacy of XANAX XR, which could impact its long-term market position.
  • Adverse reactions and dependence risks are significant considerations for XANAX XR.

FAQs

Q: What is the projected market size for benzodiazepine drugs by 2032?

The global benzodiazepine drugs market is forecasted to reach US$ 3.1 billion by 2032[2].

Q: How does publication bias affect the perceived efficacy of XANAX XR?

Publication bias may have inflated the effectiveness of XANAX XR for panic disorder by more than 40%, suggesting its actual efficacy might be lower than reported[1].

Q: What are the common adverse reactions associated with XANAX XR?

Common adverse reactions include sedation, somnolence, dysarthria, and coordination abnormalities, leading to discontinuation in approximately 17% of patients[3].

Q: How does the regional market performance impact XANAX XR?

North America, particularly the U.S., dominates the market due to high anxiety disorder prevalence and increased FDA approvals, driving the growth of XANAX XR[2][4].

Q: What are the long-term growth drivers for the benzodiazepine market?

Rising urbanization, extraordinary work pressure, and increased awareness of mental health issues will continue to drive the demand for benzodiazepine drugs, including XANAX XR[2].

Sources

  1. Medical News Today: "Xanax's effectiveness for treating anxiety may be exaggerated"[1]
  2. Fact.MR: "Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032"[2]
  3. Pfizer: "Highlights of Prescribing Information - XANAX XR"[3]
  4. BioSpace: "Benzodiazepine Drugs Market: Alprazolam to be highly lucrative segment"[4]

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