You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 21, 2024

DARAPRIM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Daraprim patents expire, and what generic alternatives are available?

Daraprim is a drug marketed by Tilde Sciences and is included in one NDA.

The generic ingredient in DARAPRIM is pyrimethamine. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Daraprim

A generic version of DARAPRIM was approved as pyrimethamine by SANALUZ on February 28th, 2020.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for DARAPRIM?
  • What are the global sales for DARAPRIM?
  • What is Average Wholesale Price for DARAPRIM?
Summary for DARAPRIM
Drug patent expirations by year for DARAPRIM
Drug Prices for DARAPRIM

See drug prices for DARAPRIM

Recent Clinical Trials for DARAPRIM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Washington University School of MedicineEarly Phase 1
Albert Einstein College of MedicinePhase 1
University of Kansas Medical CenterPhase 1

See all DARAPRIM clinical trials

Pharmacology for DARAPRIM

US Patents and Regulatory Information for DARAPRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tilde Sciences DARAPRIM pyrimethamine TABLET;ORAL 008578-001 Approved Prior to Jan 1, 1982 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

DARAPRIM Market Analysis and Financial Projection Experimental

The Daraprim Saga: Understanding the Market Dynamics and Financial Trajectory

Introduction

The story of Daraprim, a drug used to treat toxoplasmosis, is a stark example of the complex and often contentious world of pharmaceutical pricing. Here, we delve into the market dynamics and financial trajectory of Daraprim, highlighting the key events, motivations, and consequences of its price hike.

Historical Context of Daraprim

Daraprim, or pyrimethamine, is a drug developed in the 1950s to treat toxoplasmosis, a parasitic infection particularly dangerous for individuals with weakened immune systems, such as those with HIV/AIDS[4][5].

The Price Hike

In August 2015, Turing Pharmaceuticals, led by CEO Martin Shkreli, acquired the U.S. marketing rights to Daraprim from Impax Laboratories. Almost immediately, Turing raised the price of Daraprim from $13.50 per tablet to $750 per tablet, a staggering 5,000% increase[1][4][5].

Market Impact

This price hike sparked widespread outrage among infectious disease doctors, advocates, and patients. The new pricing structure made the annual cost of treatment for toxoplasmosis unsustainable, with estimates ranging from $336,000 to $634,500 depending on the patient's weight[1].

Economic Motivations

The primary reason behind the price increase was not related to research or development costs but rather economic opportunism. Turing Pharmaceuticals exploited its monopoly on the drug, knowing that Daraprim had no patent or regulatory protection and was essential for treating a specific condition. This move was part of a broader trend where companies acquire older drugs and significantly raise their prices due to the lack of generic competition[1][3][4].

Monopoly and Anti-Competitive Practices

To maintain its monopoly, Turing and its parent company, Vyera, implemented a complex scheme to block generic competition. This included contractual restrictions that prohibited distributors and purchasers from reselling Daraprim to generic companies or their agents. These practices were aimed at stifling competition and ensuring that the high price of Daraprim remained unchallenged[3].

Competitive Response

In response to Turing's price hike, Imprimis Pharmaceuticals announced plans to produce a formulation of pyrimethamine at a significantly lower price, around $1 per capsule. This move was seen as a market opportunity to undercut the exorbitant prices set by Turing and demonstrated that it was possible to make a profit without exploiting patients[2].

Financial Trajectory

The immediate financial impact for Turing Pharmaceuticals was significant. The price hike led to a substantial increase in annual revenues from Daraprim. However, this revenue boost was short-lived due to the intense public backlash and regulatory scrutiny that followed. The company's reputation suffered severely, and the long-term viability of such pricing strategies was questioned[1][3][4].

Regulatory and Legal Consequences

The actions of Turing Pharmaceuticals and its executives, including Martin Shkreli, led to several legal challenges. The California Department of Justice filed a complaint alleging that the company had engaged in anti-competitive practices to maintain its monopoly on Daraprim. These legal battles highlighted the need for stricter regulations to prevent such predatory pricing in the pharmaceutical industry[3].

Ethical and Social Implications

The Daraprim case raised critical ethical questions about drug pricing. The massive price hike had severe implications for vulnerable patient populations, who were either forced to pay exorbitant prices or go without the necessary medication. This scenario underscored the need for a broader conversation about fair drug pricing and the mechanisms to enforce ethical standards in the pharmaceutical industry[4].

Industry Trends and Broader Context

The Daraprim case is not an isolated incident. Other pharmaceutical companies, such as Valeant and Horizon Pharmaceuticals, have also been involved in similar price hikes for acquired drugs. This trend has sparked debates about the balance between profit incentives for drug development and the protection of consumer interests[4].

Key Takeaways

  • Monopoly Exploitation: The Daraprim price hike was a result of Turing Pharmaceuticals exploiting its monopoly on the drug.
  • Anti-Competitive Practices: The company implemented various schemes to block generic competition.
  • Financial Impact: The price hike led to short-term financial gains but long-term reputational damage and legal consequences.
  • Ethical Concerns: The case highlighted the need for ethical standards in drug pricing to protect vulnerable patient populations.
  • Regulatory Scrutiny: The incident led to increased regulatory scrutiny and calls for stricter laws to prevent predatory pricing.

FAQs

Q: Why did Turing Pharmaceuticals raise the price of Daraprim so dramatically? A: Turing raised the price to exploit its monopoly on the drug, aiming to maximize profits despite the drug being off-patent and having been developed over 60 years ago.

Q: What were the immediate consequences of the price hike for patients? A: The price hike made the treatment unaffordable for many patients, with annual costs estimated to range from $336,000 to $634,500.

Q: How did other companies respond to Turing's price hike? A: Imprimis Pharmaceuticals announced plans to produce a cheaper alternative, selling pyrimethamine for about $1 per capsule, significantly undercutting Turing's price.

Q: What legal actions were taken against Turing Pharmaceuticals? A: The California Department of Justice filed a complaint alleging anti-competitive practices aimed at maintaining a monopoly on Daraprim.

Q: What broader implications does the Daraprim case have for the pharmaceutical industry? A: The case highlights the need for ethical standards in drug pricing, stricter regulations to prevent predatory pricing, and a balance between profit incentives and consumer protection.

Sources

  1. CBS News: "Price of drug Daraprim increases 5,000 percent overnight"
  2. Los Angeles Times: "Drug pricing: That pill that went from $13.50 to $750 can now be had for $1"
  3. California Department of Justice: "Vyera Amended Complaint"
  4. Stanford Law School: "Daraprim and Predatory Pricing: Martin Shkreli's 5000% Hike"
  5. BioSpace: "Turing Pharmaceuticals Acquires U.S. Marketing Rights to Daraprim (pyrimethamine)"

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.