ZERIT Drug Patent Profile

Which patents cover Zerit, and what generic alternatives are available?

Zerit is a drug marketed by Bristol and Bristol Myers Squibb and is included in three NDAs.

The generic ingredient in ZERIT is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for ZERIT

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	5,000
Drug Prices:	Drug price information for ZERIT
What excipients (inactive ingredients) are in ZERIT?	ZERIT excipients list
DailyMed Link:	ZERIT at DailyMed

See drug prices for ZERIT

US Patents and Regulatory Information for ZERIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994		DISCN	Yes	No

Expired US Patents for ZERIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994	4,978,655*PED
Bristol	ZERIT	stavudine	FOR SOLUTION;ORAL	020413-001	Sep 6, 1996	4,978,655*PED
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-005	Jun 24, 1994	4,978,655*PED

EU/EMA Drug Approvals for ZERIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Zerit	stavudine	EMEA/H/C/000110 Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.	Withdrawn	no	no	no	1996-05-08

International Patents for ZERIT

See the table below for patents covering ZERIT around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	873245
Spain	2038650
South Africa	8707171

Supplementary Protection Certificates for ZERIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273277	SPC/GB96/049	United Kingdom		PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0273277	C960024	Netherlands		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
0383472	96C0040	Belgium		PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:

ZERIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Anti-HIV Drugs: A Focus on ZERIT

Introduction

The global anti-HIV drugs market is one of the fastest-growing pharmaceutical markets, driven by the increasing prevalence of HIV and the continuous development of new, more effective treatments. This article will delve into the market dynamics and financial trajectory of anti-HIV drugs, with a specific focus on ZERIT, a notable medication in this sector.

Global Anti-HIV Drugs Market Overview

The global anti-HIV drugs market was valued at USD 26,883.4 million in 2019 and is expected to grow with a Compound Annual Growth Rate (CAGR) of 6.2% from 2020 to 2032[1].

Prevalence of HIV and Market Drivers

The rising prevalence of HIV, particularly in developing and underdeveloped countries, is a significant driver of the market. As of 2018, approximately 39.7 million people globally had HIV, and about 1.7 million people died from the disease. The lack of adequate prevention measures and treatment facilities in these regions exacerbates the need for effective anti-HIV drugs[1].

Key Market Players and Innovations

Prominent market players such as Gilead Sciences Inc., GSK, Merck & Co., Inc., and Roche are actively involved in developing new products. These companies are leveraging innovative technologies like cell therapy and immunomodulation to create more effective drugs. For instance, Gilead Sciences Inc. has developed drugs like Truvada, Atripla, and Stribild, which are widely used in HIV treatment[1].

Regional Market Dynamics

North America dominates the anti-HIV drugs market due to the presence of leading market players and significant public investment in HIV research, such as that from the National Institutes of Health (NIH) in the U.S. The Asia-Pacific region is expected to witness the fastest growth, driven by rising healthcare spending, favorable government regulations, and high unmet drug demand in countries like India and China[1].

ZERIT: A Specific Anti-HIV Drug

Overview of ZERIT

ZERIT, also known as stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV infection. It works by inhibiting the reverse transcriptase enzyme, which is essential for the replication of the HIV virus.

Market Position

ZERIT, while not as prominently mentioned in recent market reports as newer drugs like Truvada or Biktarvy, has been a part of the anti-HIV drug arsenal for several years. Its market position is influenced by the availability of newer, more potent drugs and the evolving treatment guidelines.

Financial Performance

The financial performance of ZERIT is tied to the broader trends in the anti-HIV drugs market. As newer drugs gain market share, older drugs like ZERIT may see a decline in sales. However, in regions where access to newer drugs is limited due to cost or availability, ZERIT can still play a significant role.

Generic Competition

The introduction of generic versions of anti-HIV drugs can significantly impact the market dynamics. Generic drugs, including those for NRTIs like ZERIT, tend to reduce prices as more competitors enter the market. According to the Federal Trade Commission, generic drug prices decline with the number of producers and approach long-run marginal costs when there are eight or more competitors[3].

Impact of Generic Versions

Generic versions of ZERIT have been available for several years, which has likely reduced its market share and revenue. The generic market dynamics suggest that as more generic versions become available, the prices of these drugs will decrease, making them more accessible but also reducing the revenue for the original brand.

Patient-Centric Approaches and Technological Advancements

The anti-HIV drug market is also influenced by patient-centric approaches and technological advancements. Bio-pharmaceutical companies are incorporating strategies to drive organizational changes and improve healthcare benefits for HIV patients. Technology development is a democratizing force, enabling more companies to enter the market and offer innovative treatments[4].

Regional Spending and Government Initiatives

In regions like the U.S., Canada, and parts of Asia-Pacific, government initiatives and increased healthcare spending are driving the market growth. For example, in the U.S., the National Institutes of Health (NIH) represents the largest public investment in HIV research globally, which significantly supports market growth[1].

Challenges and Opportunities

Unmet Treatment Needs

The unmet treatment needs in developing and underdeveloped countries present lucrative opportunities for market growth. However, these regions face challenges such as low income and high drug prices, which hinder access to effective treatments[1].

Awareness and Education

Governments and international organizations are organizing awareness programs to raise awareness about HIV and its treatment options. This increased awareness can drive market growth by increasing the demand for anti-HIV drugs[1].

Key Takeaways

• The global anti-HIV drugs market is growing rapidly, driven by increasing HIV prevalence and innovative drug developments.
• North America dominates the market, while the Asia-Pacific region is expected to witness the fastest growth.
• ZERIT, as an older NRTI, faces competition from newer drugs and generic versions, impacting its market share and revenue.
• Patient-centric approaches and technological advancements are crucial in driving market growth and improving treatment outcomes.
• Unmet treatment needs in developing regions present significant opportunities for market expansion.

FAQs

What is the current market size of the global anti-HIV drugs market?

The global anti-HIV drugs market was valued at USD 26,883.4 million in 2019 and is expected to grow with a CAGR of 6.2% from 2020 to 2032[1].

Which region dominates the anti-HIV drugs market?

North America dominates the anti-HIV drugs market due to the presence of leading market players and significant public investment in HIV research[1].

What are the key drivers of the anti-HIV drugs market?

Key drivers include the rising prevalence of HIV, innovative drug developments, and favorable government regulations, especially in the Asia-Pacific region[1].

How does the availability of generic versions impact the market for drugs like ZERIT?

The availability of generic versions reduces prices and market share for brand-name drugs like ZERIT, making treatments more accessible but also reducing revenue for the original brand[3].

What role do patient-centric approaches play in the anti-HIV drugs market?

Patient-centric approaches drive organizational changes and improve healthcare benefits for HIV patients, contributing to market growth and better treatment outcomes[4].

Which companies are leading the development of new anti-HIV drugs?

Prominent companies include Gilead Sciences Inc., GSK, Merck & Co., Inc., and Roche, which are actively developing new products using innovative technologies[1].

Sources

1. Straits Research: Global Anti-HIV Drugs Market Size, Top Share, Forecast to 2032.
2. Bristol Myers Squibb: 2014 Annual Report.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. GlobeNewswire: United States HIV Infection Drug Market Report 2021-2026.
5. PBS: Human Immunodeficiency Virus (HIV) - PBS.