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Last Updated: March 13, 2025

LEVO-DROMORAN Drug Patent Profile


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Which patents cover Levo-dromoran, and when can generic versions of Levo-dromoran launch?

Levo-dromoran is a drug marketed by Valeant Pharm Intl and is included in two NDAs.

The generic ingredient in LEVO-DROMORAN is levorphanol tartrate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Levo-dromoran

A generic version of LEVO-DROMORAN was approved as levorphanol tartrate by HIKMA on March 31st, 2000.

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Summary for LEVO-DROMORAN
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 11
DailyMed Link:LEVO-DROMORAN at DailyMed
Drug patent expirations by year for LEVO-DROMORAN

US Patents and Regulatory Information for LEVO-DROMORAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Valeant Pharm Intl LEVO-DROMORAN levorphanol tartrate INJECTABLE;INJECTION 008719-001 Dec 19, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Valeant Pharm Intl LEVO-DROMORAN levorphanol tartrate TABLET;ORAL 008720-001 Dec 19, 1991 DISCN Yes 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 2 of 2 entries

Market Dynamics and Financial Trajectory for Levo-Dromoran

Introduction

Levo-Dromoran, a brand-name opioid medication, is part of a broader class of drugs that have been under scrutiny due to their potential for abuse and the complexities of their market dynamics. Here, we will delve into the market dynamics, financial trajectory, and other relevant factors influencing Levo-Dromoran.

Overview of Levo-Dromoran

Levo-Dromoran is an opioid analgesic used for the management of moderate to severe pain. It belongs to the class of drugs known as levorphanol tartrate, which is a synthetic opioid agonist.

Market Dynamics

Demand and Supply

The demand for opioid medications like Levo-Dromoran is influenced by several factors, including the prevalence of chronic pain, regulatory approvals, and the availability of alternative pain management options. The rising prevalence of cancer and chronic pain conditions has driven the demand for pain therapeutics, including opioids[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of opioid medications. Regulatory approvals and the introduction of abuse-deterrent formulations have supported the market growth. However, stringent regulations and increased scrutiny due to opioid misuse have also impacted the market negatively[3].

Competition

The opioid market is highly competitive, with several brand-name and generic drugs available. Levo-Dromoran competes with other opioids such as fentanyl, hydrocodone, and oxycodone. The competition is further intensified by the availability of generic equivalents once the patent and market exclusivity periods expire[4].

Financial Trajectory

Revenue Trends

The financial performance of Levo-Dromoran is tied to the broader trends in the opioid market. The global opioids market was valued at US$ 27.28 billion in 2022 and is expected to grow at a CAGR of 4.54% from 2023 to 2029, reaching US$ 37.24 billion by 2029[3].

Pricing Dynamics

Pricing is a critical factor in the financial trajectory of prescription drugs. Brand-name drugs, including Levo-Dromoran, often experience significant price increases, especially when they are under patent protection. However, once generics enter the market, prices can drop substantially. From 2000 to 2008, many brand-name drugs, including some opioids, saw extraordinary price increases, which were driven by factors such as market exclusivity and lack of competition[4].

Impact of Generic Competition

The introduction of generic versions of opioid medications can significantly impact the revenue of brand-name drugs like Levo-Dromoran. Generic erosion assumptions and profitability assumptions are key components in financial analyses when generics are about to enter the market. For instance, the financial provisions and agreements between companies, such as those discussed in the Impax Laboratories trial transcript, highlight the importance of anticipating generic competition and its financial implications[5].

Patient Demographics and Prescription Trends

Age and Gender

While specific data on Levo-Dromoran is not provided, trends in opioid prescriptions can offer insights. For example, prescriptions for stimulants and other controlled substances have shown demographic shifts, with females experiencing a higher percent increase in prescriptions than males in recent years. Similarly, age groups such as the 31-40 years old segment have seen significant increases in prescription rates for certain controlled substances[1].

Regional Variations

Regional differences in prescription rates and regulatory environments can also affect the market dynamics of Levo-Dromoran. Telemedicine, which saw a surge during the COVID-19 pandemic, has also influenced prescription trends, although its impact varies by region[1].

Challenges and Opportunities

Misuse and Regulatory Scrutiny

One of the major challenges facing Levo-Dromoran and other opioid medications is the extensive misuse and the resulting regulatory scrutiny. The growing incidence of opioid overdose and related deaths has led to increased regulatory measures and public health initiatives aimed at curbing opioid abuse. This scrutiny can impact the market negatively but also drives the development of abuse-deterrent formulations, which can be a market opportunity[3].

Innovation and Abuse-Deterrent Formulations

The development of innovative, abuse-deterrent formulations is a significant opportunity for drugs like Levo-Dromoran. These formulations can help mitigate the risk of misuse while maintaining therapeutic efficacy, which can be a competitive advantage in the market[3].

Key Takeaways

  • Market Growth: The opioid market, including Levo-Dromoran, is expected to grow, driven by the demand for pain therapeutics.
  • Regulatory Impact: Regulatory approvals and scrutiny significantly influence the market dynamics.
  • Generic Competition: The introduction of generics can substantially impact the revenue of brand-name drugs.
  • Patient Demographics: Demographic shifts in prescription trends can affect the market.
  • Innovation: Abuse-deterrent formulations offer a competitive advantage and market opportunity.

FAQs

What is Levo-Dromoran used for?

Levo-Dromoran is used for the management of moderate to severe pain.

How does the regulatory environment impact Levo-Dromoran?

The regulatory environment influences the market through approvals, scrutiny due to misuse, and the introduction of abuse-deterrent formulations.

What is the expected growth of the opioid market?

The global opioids market is expected to grow at a CAGR of 4.54% from 2023 to 2029, reaching US$ 37.24 billion by 2029.

How does generic competition affect Levo-Dromoran?

Generic competition can significantly reduce the revenue of Levo-Dromoran once generics enter the market.

What are the key challenges facing Levo-Dromoran?

The key challenges include extensive misuse, regulatory scrutiny, and the need for innovation in abuse-deterrent formulations.

Sources

  1. IQVIA Report on Stimulant Trends from 2012 - 2022. U.S. Department of Justice, Drug Enforcement Administration.
  2. BOARD MEETING AGENDA. Oregon.gov.
  3. Opioids Drugs Market- Global Industry Analysis and Forecast (2023 .... Maximize Market Research.
  4. GAO-10-201 Brand-Name Prescription Drug Pricing. U.S. Government Accountability Office.
  5. Impax Laboratories, Inc.: Transcript of Trial Proceedings (Volume 3). Federal Trade Commission.

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