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Last Updated: March 26, 2025

LUXZYLA Drug Patent Profile


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

Luxzyla is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in LUXZYLA is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Luxzyla

A generic version of LUXZYLA was approved as penicillamine by WATSON LABS INC on June 24th, 2019.

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Summary for LUXZYLA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:LUXZYLA at DailyMed
Drug patent expirations by year for LUXZYLA
Pharmacology for LUXZYLA

US Patents and Regulatory Information for LUXZYLA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Ani Pharms LUXZYLA penicillamine CAPSULE;ORAL 209921-001 May 7, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory of Prescription Drugs: A Case Study on Trends and Implications

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by various factors including regulatory changes, technological advancements, and market competition. This article will delve into the market dynamics and financial trajectory of prescription drugs, using recent trends and data to illustrate key points.

Overall Prescription Drug Spending

Between 2016 and 2021, prescription drug spending in the United States exhibited significant growth. Total expenditures on prescription drugs increased from $520 billion in 2016 to $603 billion in 2021, a 16% increase. This growth rate was consistent with the overall national health care spending growth, with prescription drugs maintaining approximately an 18% share of total health care expenditures[1].

Retail vs. Non-Retail Drug Spending

Retail drug expenditures represented roughly 70% of prescription drug spending, while non-retail expenditures accounted for about 30%. There was a 13% increase in retail prescription drug spending over this period, but only a 5.7% increase in the number of retail prescriptions. This indicates that the primary driver of increased retail drug spending was not the number of prescriptions filled, but rather a 7% increase in spending per prescription[1].

Specialty Drug Spending

Specialty drug spending saw a substantial increase, rising by 43% between 2016 and 2021 to reach $301 billion. Despite a minimal 0.5% increase in the number of specialty prescriptions, the spending per prescription drove this growth. In the retail sector, the share of spending on specialty drugs increased by 22%, while in the non-retail sector, it increased by 20% over the same period[1].

Generic vs. Brand Name Drugs

The dynamics between generic and brand name drugs are crucial in understanding market trends. For generic drugs, there was a steady decline in retail expenditures but an increase in non-retail expenditures. Brand name drugs, however, saw a continuous increase in total expenditures despite variations in the number of prescriptions. This increase was largely due to growth in spending per prescription[1].

Impact of New Drug Approvals

New drug approvals significantly influence the market. By 2021, new drugs introduced after 2016 accounted for 20% of specialty drug spending in both retail and non-retail settings. This trend highlights the continuous innovation and shifting priorities in drug development and spending[1].

Competition and Pricing in the Generic Drug Market

The generic drug market is characterized by intense competition. Generic drug prices fall as the number of competitors increases, but they remain above long-run marginal costs until there are at least 8 competitors. Early entrants into the generic market often gain significant advantages, including higher profits and earlier market access[5].

Regulatory and Policy Impacts

Regulatory changes can significantly affect the drug market. For instance, the FDA's increased scrutiny of generic drug applications in the late 1980s raised the cost of obtaining approval, which in turn affected generic prices. Policies that allow simultaneous approval of multiple generic entrants can also impact market dynamics and competition[5].

Financial Trajectory of Pharmaceutical Companies

The financial performance of pharmaceutical companies is closely tied to these market dynamics. Companies that successfully navigate the complexities of drug development, regulatory approvals, and market competition can achieve significant financial growth. For example, the rise in spending on specialty drugs and the increasing importance of new drug approvals can drive revenue and profitability for companies that innovate and adapt quickly[1].

Case Study: Understanding Market Dynamics

To illustrate these points, consider the broader pharmaceutical market trends:

  • Spending Growth: The consistent growth in prescription drug spending, particularly in the specialty drug segment, indicates a market where innovation and high-cost treatments are driving expenditures.
  • Competition: The generic drug market's dynamics show how competition can drive prices down, but also highlight the challenges and opportunities for early entrants.
  • Regulatory Impact: Changes in regulatory policies can affect the cost and timing of drug approvals, influencing market entry and competition.

Key Takeaways

  • Growth in Prescription Drug Spending: Total expenditures on prescription drugs have increased significantly, driven by specialty drugs and higher spending per prescription.
  • Competition in Generic Drugs: Increased competition in the generic drug market leads to lower prices, but early entrants can gain significant advantages.
  • Regulatory Influence: Regulatory changes can impact the cost and timing of drug approvals, affecting market dynamics.
  • Innovation and New Drug Approvals: New drug approvals play a crucial role in driving spending and innovation in the pharmaceutical industry.

FAQs

What drove the increase in prescription drug spending between 2016 and 2021?

The increase in prescription drug spending was primarily driven by a rise in spending per prescription, rather than an increase in the number of prescriptions filled[1].

How has the generic drug market been affected by competition?

Generic drug prices decrease as the number of competitors increases, but they remain above long-run marginal costs until there are at least 8 competitors[5].

What is the impact of new drug approvals on the pharmaceutical market?

New drug approvals significantly influence the market, with new drugs introduced after 2016 accounting for 20% of specialty drug spending by 2021[1].

How do regulatory changes affect the pharmaceutical industry?

Regulatory changes, such as increased scrutiny of generic drug applications, can raise the cost of obtaining approval and affect generic prices[5].

What is the significance of specialty drugs in the pharmaceutical market?

Specialty drugs have seen substantial growth, with a 43% increase in spending between 2016 and 2021, driven by higher spending per prescription despite minimal increases in the number of prescriptions[1].

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
  2. LuxUrban Hotels Inc. Announces Record 2023 Third Quarter Financial Results - Business Wire
  3. Understanding the Dynamics of Drug Expenditure - IQVIA
  4. LuxUrban Hotels Inc. Announces 2023 Financial Results - Business Wire
  5. Generic Drug Industry Dynamics - Federal Trade Commission

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