STAVUDINE - Generic Drug Details

What are the generic sources for stavudine and what is the scope of patent protection?

Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Aurobindo Pharma, Hetero Labs Ltd Iii, Norvium Bioscience, Bristol, and Cipla Ltd, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for stavudine. There are ten tentative approvals for this compound.

Summary for STAVUDINE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	14
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	173
Patent Applications:	7,488
What excipients (inactive ingredients) are in STAVUDINE?	STAVUDINE excipients list
DailyMed Link:	STAVUDINE at DailyMed

Recent Clinical Trials for STAVUDINE

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

Sponsor	Phase
Christian Medical College, Vellore, India	Phase 4
Tufts University	Phase 4
Chulalongkorn University	Phase 2/Phase 3

See all STAVUDINE clinical trials

Generic filers with tentative approvals for STAVUDINE

Applicant	Application No.	Strength	Dosage Form
		40MG; 150MG; 200MG	TABLET; ORAL
		40MG; 150MG	TABLET; ORAL
		40MG; 150MG; 200MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for STAVUDINE

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for STAVUDINE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for STAVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	STAVUDINE	stavudine	CAPSULE;ORAL	078957-004	Dec 29, 2008		DISCN	No	No
Hetero Labs Ltd Iii	STAVUDINE	stavudine	CAPSULE;ORAL	078957-003	Dec 29, 2008		DISCN	No	No
Hetero Labs Ltd Iii	STAVUDINE	stavudine	CAPSULE;ORAL	078957-001	Dec 29, 2008		DISCN	No	No
Aurobindo Pharma	STAVUDINE	stavudine	CAPSULE;ORAL	077672-003	Dec 29, 2008		DISCN	No	No
Norvium Bioscience	STAVUDINE	stavudine	CAPSULE;ORAL	079069-002	Dec 29, 2008		DISCN	No	No
Aurobindo Pharma	STAVUDINE	stavudine	CAPSULE;ORAL	077672-001	Dec 29, 2008		DISCN	No	No

Expired US Patents for STAVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002	4,978,655*PED
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002	4,978,655*PED
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-003	Jun 24, 1994	4,978,655*PED
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-002	Jun 24, 1994	4,978,655*PED
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994	4,978,655*PED
Bristol	ZERIT	stavudine	FOR SOLUTION;ORAL	020413-001	Sep 6, 1996	4,978,655*PED

EU/EMA Drug Approvals for STAVUDINE

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

STAVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Stavudine

Introduction to Stavudine

Stavudine, also known as d4T, is a small molecule drug primarily used for the treatment of HIV infections. It targets the HIV-1 reverse transcriptase (RT) enzyme, a crucial component in the replication of the HIV virus. First approved in the United States in June 1994 by Bristol Myers Squibb Co., stavudine has since gained global recognition and approval in various countries, including China[4].

Global Pharmaceutical Market Context

The global pharmaceutical market, which includes both chemical and biological drugs, was valued at $1,475 billion in 2022 and is expected to grow at a CAGR of 5% over the next six years. The chemical drug market, where stavudine is categorized, was estimated to be $1,094 billion in 2022, up from $1,005 billion in 2018[1].

Market Size and Forecast for Stavudine

The global stavudine market is projected to reach $431.9 million by 2030, growing at a CAGR of 4.8% from 2024 to 2030. This growth is driven by several factors, including increasing demand for HIV treatments, technological advancements, and the rising prevalence of chronic diseases[1].

Market Segmentation

The stavudine market is segmented by type, application, and region.

By Type

• The market is segmented into various dosages such as 15mg, 20mg, 30mg, and 40mg. Each dosage has its specific market share and growth trajectory[1].

By Application

• Stavudine is primarily used in hospitals and drug stores. The demand from these sectors is expected to drive the market growth, with hospitals being the major consumers due to the need for antiretroviral therapy (ART) in patient care[1].

By Region

• The market is geographically segmented into North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Asia Pacific, particularly countries like China, India, and Japan, is expected to show significant growth due to the large patient population and increasing healthcare expenditure[1].

Driving Factors

Several factors are driving the growth of the stavudine market:

Increasing Demand for HIV Treatments

• The rapid scale-up of antiretroviral therapy (ART) in resource-limited settings has increased the demand for antiretroviral medicines, including stavudine. This demand is expected to continue as more people receive ART[2].

Technological Advancements

• Advances in pharmaceutical technology and the development of new antiretroviral drugs have improved treatment outcomes and patient adherence, contributing to the market growth[1].

Rising Prevalence of Chronic Diseases

• The increasing prevalence of chronic diseases, including HIV, has led to a higher demand for effective treatments like stavudine[1].

Restrictive Factors

Despite the growth drivers, the stavudine market faces several challenges:

Stringent Regulations

• Pharmaceutical companies must navigate stringent regulatory environments, which can delay the approval and launch of new drugs or formulations[1].

High R&D Costs

• The high costs associated with research and development (R&D) can be a significant barrier for companies, especially for drugs like stavudine that require continuous innovation to stay competitive[1].

Patent Expirations

• The expiration of patents can lead to increased competition from generic drugs, potentially reducing the market share of branded stavudine products[1].

Phase-Out Scenarios

There are ongoing efforts to phase out stavudine due to its toxicity and the availability of newer, less toxic antiretroviral drugs. Studies have projected demand under fast and slower phase-out scenarios of stavudine, indicating a shift towards drugs like tenofovir, emtricitabine, and efavirenz[2].

Competitive Landscape

The stavudine market is competitive, with key players including Aurobindo Pharma, Bristol Myers Squibb, Hetero Drugs, Matrix Laboratories, Mylan Pharmaceuticals, and Cipla. These companies are involved in continuous R&D to improve their products and maintain market share[1].

Regional Market Dynamics

Asia Pacific

• This region is expected to be a significant growth driver due to the large patient population and increasing healthcare expenditure. Countries like China, India, and Japan are key markets for stavudine[1].

North America and Europe

• These regions have established healthcare systems and high demand for antiretroviral drugs. However, the market growth here may be slower compared to the Asia Pacific region due to market saturation and the availability of newer drugs[1].

Latin America and Middle East & Africa

• These regions also present growth opportunities, particularly as healthcare infrastructure improves and access to antiretroviral therapy increases[1].

Financial Trajectory

The financial trajectory of the stavudine market is influenced by several factors:

Revenue and Sales Volume

• The market is expected to generate $431.9 million in revenue by 2030, with a CAGR of 4.8% from 2024 to 2030. The sales volume is also projected to increase, driven by the growing demand for HIV treatments[1].

Average Price

• The average price of stavudine is expected to stabilize or slightly decrease due to competition from generic drugs and the phase-out of branded products[1].

Regional Revenue Growth

• The revenue growth rate varies by region, with Asia Pacific showing the highest growth potential. For example, countries like China and India are expected to see significant revenue growth rates due to their large patient populations and increasing healthcare spending[1].

Impact of COVID-19

The COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management in the pharmaceutical industry. While stavudine is not directly related to COVID-19 treatments, the pandemic has emphasized the need for pharmaceutical companies to be agile and responsive to emerging public health needs, which could indirectly influence the market dynamics of antiretroviral drugs[1].

Regulatory Status

Stavudine has been granted accelerated approval and orphan drug designation, which are regulatory pathways that expedite the approval of drugs addressing unmet medical needs. These designations underscore the significance of stavudine in managing HIV infections and provide it with certain market protections[4].

Conclusion

The stavudine market is driven by increasing demand for HIV treatments, technological advancements, and the rising prevalence of chronic diseases. However, it faces challenges such as stringent regulations, high R&D costs, and patent expirations. As the market evolves, there is a shift towards newer, less toxic antiretroviral drugs, but stavudine remains a valuable tool in the management of HIV infections.

Key Takeaways

• Market Growth: The global stavudine market is projected to reach $431.9 million by 2030, growing at a CAGR of 4.8%.
• Segmentation: The market is segmented by type (dosage), application (hospitals and drug stores), and region.
• Driving Factors: Increasing demand for HIV treatments, technological advancements, and rising prevalence of chronic diseases.
• Restrictive Factors: Stringent regulations, high R&D costs, and patent expirations.
• Regional Dynamics: Asia Pacific is expected to be a significant growth driver.

FAQs

Q: What is the primary use of stavudine?

• Stavudine is primarily used for the treatment of HIV infections by targeting the HIV-1 reverse transcriptase (RT) enzyme.

Q: Which regions are expected to drive the growth of the stavudine market?

• The Asia Pacific region, particularly countries like China, India, and Japan, is expected to drive the growth of the stavudine market.

Q: What are the key challenges facing the stavudine market?

• The key challenges include stringent regulations, high R&D costs, and patent expirations.

Q: How has the COVID-19 pandemic impacted the pharmaceutical market?

• The COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management, emphasizing the need for pharmaceutical companies to be agile and responsive to emerging public health needs.

Q: What regulatory designations has stavudine received?

• Stavudine has been granted accelerated approval and orphan drug designation, which expedite its approval and provide certain market protections.

References

1. Global Stavudine Market Research Report 2024 - QYResearch
2. Utilization Patterns and Projected Demand of Antiretroviral Drugs in Low- and Middle-Income Countries - Wiley Online Library
3. HIV Drugs and Injectables Market Report 2024-2034 - Visiongain
4. Stavudine: Detailed Review of its Transformative R&D Success - Synapse
5. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial - Open Forum Infectious Diseases