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Last Updated: December 22, 2024

HYDROCODONE BITARTRATE AND ASPIRIN Drug Patent Profile


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Which patents cover Hydrocodone Bitartrate And Aspirin, and when can generic versions of Hydrocodone Bitartrate And Aspirin launch?

Hydrocodone Bitartrate And Aspirin is a drug marketed by Lgm Pharma and is included in one NDA.

The generic ingredient in HYDROCODONE BITARTRATE AND ASPIRIN is aspirin; hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; hydrocodone bitartrate profile page.

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Summary for HYDROCODONE BITARTRATE AND ASPIRIN
Drug patent expirations by year for HYDROCODONE BITARTRATE AND ASPIRIN

US Patents and Regulatory Information for HYDROCODONE BITARTRATE AND ASPIRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lgm Pharma HYDROCODONE BITARTRATE AND ASPIRIN aspirin; hydrocodone bitartrate TABLET;ORAL 205479-001 May 28, 2021 RX No Yes ⤷  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

HYDROCODONE BITARTRATE AND ASPIRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocodone Bitartrate and Aspirin

Introduction

Hydrocodone Bitartrate and Aspirin Tablets are a combination medication used for the management of severe pain that requires opioid analgesic treatment. This article delves into the market dynamics and financial trajectory of this drug, highlighting its usage, risks, regulatory environment, and economic implications.

Indications and Usage

Hydrocodone Bitartrate and Aspirin Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. This medication is typically prescribed for short-term pain relief, especially when other pain medicines have not been effective or cannot be tolerated[1][2].

Market Demand

The demand for hydrocodone-based medications, including Hydrocodone Bitartrate and Aspirin, has been significant due to the prevalence of chronic and acute pain conditions. However, this demand has been tempered by increasing regulatory scrutiny and public health concerns related to opioid abuse and misuse.

Regulatory Environment

The regulatory landscape for hydrocodone products has become more stringent in recent years. In 2014, the DEA rescheduled hydrocodone combination products from Schedule III to Schedule II controlled substances, imposing stricter controls on storage, record-keeping, and prescribing practices. This change was driven by the increasing reports of abuse and the need to mitigate the opioid crisis[3][4].

Safety and Risk Profile

Hydrocodone Bitartrate and Aspirin Tablets carry significant risks, including opioid addiction, abuse, and misuse, which can lead to overdose and death. Other serious risks include life-threatening respiratory depression, especially during initiation or dosage increases, and accidental ingestion, which can be fatal, particularly in children[1].

Impact on Market Dynamics

The stringent regulatory measures and the high risk profile of hydrocodone products have impacted market dynamics. There has been a concerted effort to reduce the prescribing of opioid medications, including hydrocodone-based products. This has led to a decline in the number of prescriptions written for these medications. For example, the number of hydrocodone-containing product prescriptions decreased from 136.7 million in 2013 to 83.6 million in 2017[4].

Financial Trajectory

The financial trajectory of Hydrocodone Bitartrate and Aspirin Tablets is closely tied to the broader trends in the opioid market. The decline in prescriptions and the increased regulatory oversight have resulted in reduced revenue for manufacturers. Additionally, the costs associated with implementing Risk Evaluation and Mitigation Strategies (REMS) and other safety measures have further impacted the financial performance of these products.

Economic Implications

The economic implications of the reduced demand and increased regulatory costs are significant. Manufacturers must invest in REMS programs, which include education for healthcare providers and patients, as well as monitoring systems to prevent misuse. These costs, combined with the decline in sales, have led to a challenging financial environment for companies producing hydrocodone-based medications.

Competitive Landscape

The competitive landscape for pain management medications is highly competitive, with various opioid and non-opioid alternatives available. The shift towards abuse-deterrent formulations and the development of new pain management therapies have further complicated the market for traditional hydrocodone products. Companies are now focusing on developing safer, more effective pain management solutions to navigate this complex market[3].

Public Health Impact

The public health impact of hydrocodone products is a critical consideration. While these medications provide essential pain relief for many patients, their potential for abuse and misuse has contributed significantly to the opioid crisis. Efforts to balance the need for effective pain management with the need to prevent abuse are ongoing, involving both regulatory bodies and healthcare providers[3][4].

Future Outlook

The future outlook for Hydrocodone Bitartrate and Aspirin Tablets is uncertain. As the healthcare industry continues to grapple with the opioid crisis, there is likely to be ongoing scrutiny and regulation of these products. The development of alternative pain management therapies and abuse-deterrent formulations may further reduce the market share of traditional hydrocodone products.

Key Takeaways

  • Regulatory Scrutiny: Hydrocodone products are subject to stringent regulations, including Schedule II classification.
  • Safety Risks: Significant risks include opioid addiction, respiratory depression, and accidental ingestion.
  • Market Decline: The number of prescriptions for hydrocodone products has declined in recent years.
  • Financial Impact: Reduced demand and increased regulatory costs have affected the financial performance of manufacturers.
  • Competitive Landscape: The market is highly competitive, with a focus on safer, more effective pain management solutions.
  • Public Health: Balancing pain management needs with abuse prevention remains a critical challenge.

FAQs

What are the primary indications for Hydrocodone Bitartrate and Aspirin Tablets?

Hydrocodone Bitartrate and Aspirin Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

What are the significant risks associated with Hydrocodone Bitartrate and Aspirin Tablets?

Significant risks include opioid addiction, abuse, and misuse, life-threatening respiratory depression, and accidental ingestion, which can be fatal, especially in children.

How have regulatory changes impacted the market for hydrocodone products?

The rescheduling of hydrocodone combination products from Schedule III to Schedule II controlled substances has imposed stricter controls on storage, record-keeping, and prescribing practices, contributing to a decline in prescriptions.

What is the current market trend for hydrocodone-based medications?

The market trend shows a decline in prescriptions due to increased regulatory oversight and public health concerns related to opioid abuse and misuse.

Are there alternative pain management options available?

Yes, there are various opioid and non-opioid alternatives available, and the development of new pain management therapies and abuse-deterrent formulations is ongoing.

Sources

  1. DailyMed: Hydrocodone Bitartrate and Aspirin tablet.
  2. Mayo Clinic: Hydrocodone and ibuprofen (oral route).
  3. FDA: Overdose Prevention Activities Timeline.
  4. DEA: Hydrocodone (Trade Names: Vicodin®, Lortab®, Lorcet-HD®).
  5. Mayo Clinic: Hydrocodone and acetaminophen (oral route).

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