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Last Updated: December 22, 2024

NYDRAZID Drug Patent Profile


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Which patents cover Nydrazid, and when can generic versions of Nydrazid launch?

Nydrazid is a drug marketed by Sandoz and Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in NYDRAZID is isoniazid. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nydrazid

A generic version of NYDRAZID was approved as isoniazid by OMNIVIUM PHARMS on June 26th, 1997.

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Summary for NYDRAZID
Drug patent expirations by year for NYDRAZID
Recent Clinical Trials for NYDRAZID

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

SponsorPhase
Medical Research CouncilPhase 3
IUATLD, IncPhase 3
Liverpool School of Tropical MedicinePhase 3

See all NYDRAZID clinical trials

US Patents and Regulatory Information for NYDRAZID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz NYDRAZID isoniazid INJECTABLE;INJECTION 008662-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb NYDRAZID isoniazid TABLET;ORAL 008392-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

NYDRAZID Market Analysis and Financial Projection Experimental

Understanding the Market Dynamics and Financial Trajectory of Nydrazid

Introduction

Nydrazid, a brand-name drug, is used in the treatment of tuberculosis and other mycobacterial infections. To comprehend its market dynamics and financial trajectory, it is crucial to delve into the broader context of the prescription drug market, particularly focusing on factors such as patent protection, market exclusivity, competition, and corporate consolidations.

Background of Brand-Name Drugs

Brand-name drugs, including Nydrazid, are drug products that have received FDA approval and typically enjoy patent protection. This protection allows the drug company to recoup research and development costs and earn a return on their investment[1][4].

Patent Protection and Market Exclusivity

Patent protection and market exclusivity play significant roles in the pricing and availability of brand-name drugs like Nydrazid. These mechanisms temporarily limit competition, enabling the drug company to maintain higher prices without immediate generic competition. For instance, if Nydrazid was patented at the time of its extraordinary price increase, this would have contributed to the lack of therapeutically equivalent drugs, thereby allowing the company to set higher prices[1][4].

Lack of Therapeutically Equivalent Drugs

The absence of therapeutically equivalent drugs, both generics and other brand-name drugs, is a key factor in extraordinary price increases. Nydrazid, being a specialized drug for treating specific conditions, may not have many alternatives, which can lead to higher prices due to limited competition[1][4].

Corporate Consolidations and Market Domination

The pharmaceutical industry has seen an increase in corporate consolidations through mergers and acquisitions. This trend can result in fewer companies producing and marketing drugs, leading to greater market domination among certain companies and reduced competition. If the rights to Nydrazid were transferred to a new company as part of such consolidation, it could have led to price increases shortly after the transfer, as observed in other case studies[1][4].

Setting Prescription Drug Prices

Unlike other markets, the health care market does not follow traditional market discipline mechanisms. Health care providers influence demand on behalf of patients, who are often unaware of the drug costs due to third-party payers. This dynamic allows drug companies to maintain higher prices without a significant decline in demand[1][4].

Extraordinary Price Increases

Nydrazid, like many other brand-name drugs, could experience extraordinary price increases. These increases are often seen in drugs that cost less than $25 per unit but can total several thousand dollars for a full course of treatment. The median increase for brand-name drug products has been around 158%, but some drugs have seen increases of over 1,000%[1][4].

Therapeutic Classes and Repackaging

Extraordinary price increases for brand-name drugs often occur within specific therapeutic classes, such as central nervous system agents, anti-infective agents, and cardiovascular agents. Nydrazid, being an anti-infective agent, falls into one of these categories. Additionally, repackaged brand-name drug products are more likely to experience such price increases[1][4].

Impact of Market Dynamics on Nydrazid

Given the factors mentioned above, Nydrazid's market dynamics would likely be influenced by:

  • Patent Protection: If Nydrazid is under patent, it would limit competition and allow for higher pricing.
  • Corporate Consolidations: If the rights to Nydrazid were transferred, it could lead to price increases.
  • Lack of Alternatives: The absence of therapeutically equivalent drugs would contribute to higher prices.
  • Health Care Market Dynamics: The influence of health care providers and third-party payers would maintain demand despite higher prices.

Financial Trajectory

The financial trajectory of Nydrazid would be marked by potential extraordinary price increases, especially if it falls under the categories mentioned above. Here are some key points:

  • Revenue Growth: Despite the potential for high price increases, the overall revenue growth for Nydrazid would depend on the size of the market and the demand for the drug.
  • Cost of Treatment: A full course of treatment for Nydrazid could total several thousand dollars, making it a significant financial burden for patients and health care systems.
  • Market Share: The drug's market share would be influenced by the level of competition and the presence of other drugs in the same therapeutic class.

Key Takeaways

  • Patent Protection and Market Exclusivity: These factors significantly influence the pricing of brand-name drugs like Nydrazid.
  • Corporate Consolidations: Mergers and acquisitions can lead to fewer drug options and higher prices.
  • Lack of Therapeutically Equivalent Drugs: This contributes to extraordinary price increases.
  • Health Care Market Dynamics: Health care providers and third-party payers play a crucial role in maintaining demand despite higher prices.
  • Financial Trajectory: Potential for high price increases, significant revenue growth, and high treatment costs.

FAQs

What role does patent protection play in the pricing of Nydrazid?

Patent protection allows the drug company to limit competition and recoup research and development costs, leading to higher prices for Nydrazid.

How do corporate consolidations affect the pricing of Nydrazid?

Corporate consolidations can result in fewer companies producing and marketing drugs, leading to greater market domination and higher prices for Nydrazid.

Why do brand-name drugs like Nydrazid experience extraordinary price increases?

Brand-name drugs like Nydrazid experience extraordinary price increases due to a lack of therapeutically equivalent drugs, patent protection, and market exclusivity.

How does the health care market influence the demand for Nydrazid?

In the health care market, providers influence demand on behalf of patients, who are often unaware of drug costs due to third-party payers, allowing drug companies to maintain higher prices.

What is the potential financial impact of Nydrazid's price increases on patients and health care systems?

The potential financial impact includes significant revenue growth for the drug company but also high treatment costs that can total several thousand dollars for a full course of treatment, posing a financial burden on patients and health care systems.

Sources

  1. GAO-10-201 Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
  2. GAO-10-201, Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.

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