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Last Updated: December 22, 2024

SOMA Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Soma

A generic version of SOMA was approved as lanreotide acetate by INVAGEN PHARMS on December 17th, 2021.

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US Patents and Regulatory Information for SOMA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp SOMA carisoprodol CAPSULE;ORAL 011792-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-002 Aug 30, 2007 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meda Pharms SOMA COMPOUND aspirin; carisoprodol TABLET;ORAL 012365-005 Jul 11, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-003 Aug 30, 2007 AB RX Yes 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

SOMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SOMA (Carisoprodol)

Introduction

Carisoprodol, commonly known by its brand name Soma®, is a centrally acting muscle relaxant that has been on the market since 1959. This article delves into the market dynamics and financial trajectory of carisoprodol, highlighting its usage, abuse, regulatory status, and economic implications.

Licit Uses and Prescription Trends

Carisoprodol is prescribed as an adjunct to rest, physical therapy, and other measures for the relief of acute, painful musculoskeletal conditions. It is available in various formulations, including single-entity tablets and combination tablets with aspirin and codeine phosphate[4].

  • Prescription Numbers: In 2017, approximately 4.2 million prescriptions of carisoprodol products were dispensed in the United States, with 4.1 million actually sold or picked up by patients. This number decreased to 3.2 million in 2018[4].

Abuse and Diversion

The diversion and abuse of carisoprodol have been significant concerns over the past decade.

  • Non-Medical Use: According to the 2012 National Survey on Drug Use and Health, 3.69 million individuals aged 12 and older reported non-medical use of Soma® at some point in their lives, a notable increase from 3.06 million in 2011[1][4].
  • Street Value: As of March 2011, the street value of Soma® tablets ranged from $1 to $5 per tablet[1][4].
  • Diversion Methods: Common methods of diversion include doctor shopping and forging prescriptions. The National Forensic Laboratory Information System (NFLIS) has reported a significant number of carisoprodol substances identified by forensic laboratories, indicating widespread diversion[4].

Regulatory Status

Carisoprodol's regulatory status varies globally.

  • US Classification: Carisoprodol is classified as a Schedule IV controlled substance under the US Controlled Substances Act, effective from January 11, 2012[1].
  • International Restrictions: It has been taken off the market in several countries, including Norway (May 2008), Sweden (November 2007), and Indonesia (September 2013). In Canada, its use is restricted and varies by province[1].

Economic Impact

The economic impact of carisoprodol is multifaceted, involving both legitimate medical use and illicit trade.

  • Prescription Costs: The cost of prescriptions and the economic burden on healthcare systems are significant. However, specific financial data on the prescription costs of carisoprodol are not readily available.
  • Illicit Market: The street value and frequent diversion of carisoprodol indicate a substantial illicit market. The economic impact of this illicit trade is difficult to quantify but is undoubtedly significant[1][4].

Market Trends and Projections

The market for carisoprodol is influenced by its regulatory status, abuse potential, and medical need.

  • Declining Legitimate Use: The number of prescriptions has been declining, partly due to increased awareness of its abuse potential and stricter regulations[4].
  • Global Variations: Searches for carisoprodol on Google Trends show regional variations, with significant interest in Latin America and India. However, these searches do not necessarily translate into legitimate prescriptions[1].

Financial Consequences of Abuse

The financial consequences of carisoprodol abuse are far-reaching.

  • Healthcare Costs: Abuse and overdose cases result in significant healthcare costs. For example, in 2017, the American Association of Poison Control Centers reported 2236 carisoprodol-related cases, including two deaths[1].
  • Law Enforcement and Forensic Costs: The diversion and analysis of carisoprodol by forensic laboratories also incur substantial costs. In 2013, 3847 substances were identified as carisoprodol by federal, state, and local forensic laboratories[4].

Industry and Public Health Response

The response to carisoprodol abuse involves both industry and public health measures.

  • Regulatory Actions: Stricter regulations, such as scheduling under the Controlled Substances Act, aim to reduce diversion and abuse[1].
  • Public Awareness: Public health campaigns and medical professional education are crucial in reducing non-medical use and promoting safe prescribing practices[4].

Conclusion

Carisoprodol, or Soma®, is a drug with a complex market dynamic due to its legitimate medical use and significant potential for abuse. The financial trajectory of this drug is marked by declining legitimate prescriptions, substantial illicit trade, and significant healthcare and law enforcement costs. Regulatory actions and public health initiatives are essential in managing its use and mitigating its negative impacts.

Key Takeaways

  • Licit Use: Carisoprodol is used for acute, painful musculoskeletal conditions but has seen declining prescription numbers.
  • Abuse and Diversion: Significant non-medical use and diversion have led to regulatory actions and public health concerns.
  • Regulatory Status: Classified as a Schedule IV controlled substance in the US and restricted or banned in several countries.
  • Economic Impact: Substantial costs associated with healthcare, law enforcement, and forensic analysis.
  • Market Trends: Regional variations in interest and declining legitimate use due to regulatory and public health measures.

FAQs

What is carisoprodol used for?

Carisoprodol is used as an adjunct to rest, physical therapy, and other measures for the relief of acute, painful musculoskeletal conditions.

Why is carisoprodol a controlled substance?

Carisoprodol is classified as a Schedule IV controlled substance due to its potential for abuse, tolerance, and dependence.

How widespread is the abuse of carisoprodol?

According to the 2012 National Survey on Drug Use and Health, 3.69 million individuals aged 12 and older reported non-medical use of Soma® at some point in their lives.

What are the economic implications of carisoprodol abuse?

The abuse of carisoprodol results in significant healthcare costs, law enforcement expenses, and forensic analysis costs.

Is carisoprodol available globally?

Carisoprodol is restricted or banned in several countries, including Norway, Sweden, and Indonesia, but it remains available in other countries with varying regulations.

Sources

  1. World Health Organization (WHO). Pre-review report: Carisoprodol - World Health Organization (WHO). September 2023.
  2. Federal Reserve Bank of New York. Projections for the SOMA Portfolio and Net Income. July 2017.
  3. Market Research Intellect. Somatuline Market Size And Forecast. 2023.
  4. Diversion Control Division. CARISOPRODOL (Trade Name: Soma®). December 2019.
  5. PR Newswire. SOMA.finance Announces Launch of Digital Asset Trading Platform. December 2023.

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