Zidovudine - Generic Drug Details

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

Zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, and Ranbaxy Labs Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for zidovudine. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for zidovudine

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	19
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	524
Patent Applications:	5,461
Drug Prices:	Drug price trends for zidovudine
What excipients (inactive ingredients) are in zidovudine?	zidovudine excipients list
DailyMed Link:	zidovudine at DailyMed

See drug prices for zidovudine

Recent Clinical Trials for zidovudine

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

Sponsor	Phase
Inflammasome Therapeutics	Phase 1
Michelle Abou-Jaoude	Phase 1
The Aurum Institute NPC	Phase 1/Phase 2

See all zidovudine clinical trials

Generic filers with tentative approvals for ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE; ORAL

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

Pharmacology for zidovudine

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for zidovudine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for zidovudine

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 zidovudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995		DISCN	No	No
Norvium Bioscience	ZIDOVUDINE	zidovudine	TABLET;ORAL	200732-001	Feb 23, 2011		DISCN	No	No
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990		RX	Yes	Yes
Aurobindo	ZIDOVUDINE	zidovudine	SOLUTION;ORAL	077268-001	Sep 19, 2005	AA	RX	No	No
Ranbaxy Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	077327-001	Sep 19, 2005		DISCN	No	No

Expired US Patents for zidovudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,818,538
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,833,130
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,818,538
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	4,724,232
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	4,724,232

Zidovudine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zidovudine

Introduction

Zidovudine, also known as AZT, is a nucleoside reverse transcriptase inhibitor (NRTI) widely used in the treatment of HIV/AIDS. The market for zidovudine, often co-formulated with other antiretroviral drugs like lamivudine, has seen significant growth and evolution. Here, we delve into the market dynamics and financial trajectory of zidovudine.

Market Size and Growth

The global zidovudine market has experienced substantial growth in recent years. As of 2023, the market size was valued at approximately $1.1 billion, with projections indicating it will reach $1.68 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of around 4-5%[4].

Market Segmentation

The zidovudine market is segmented based on several key factors:

• Type: Zidovudine is available in various forms, including tablets and capsules. Each form has its own market share and growth prospects[1].
• Application: The drug is used in hospitals, clinics, drug centers, and other healthcare facilities. The demand from these segments varies geographically and is influenced by healthcare infrastructure and patient access[1].
• Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics, driven by local healthcare policies, patient population, and economic conditions[1].

Drivers of Market Growth

Several factors drive the growth of the zidovudine market:

• Increasing Prevalence of HIV/AIDS: The ongoing global effort to combat HIV/AIDS has led to an increased demand for antiretroviral therapies, including zidovudine[3].
• Advancements in Treatment Regimens: The development of combination therapies, such as the co-formulation of zidovudine with lamivudine and other antiretrovirals, has improved treatment outcomes and patient compliance[5].
• Government Initiatives and Funding: Many governments and international organizations have initiated programs to provide access to antiretroviral drugs, including zidovudine, especially in developing countries[1].

Restraints and Challenges

Despite the growth, the zidovudine market faces several challenges:

• Side Effects and Toxicity: Zidovudine is associated with significant side effects, including bone marrow cytotoxicities, anemia, and neutropenia. These adverse effects can limit its use and impact patient adherence[3].
• Resistance and Mutations: The emergence of drug-resistant HIV strains, such as the K65R mutation, poses a challenge to the efficacy of zidovudine. This has led to the development of new dosing regimens and combination therapies[3].
• Competition from Alternative Therapies: The availability of other NRTIs, such as abacavir, and newer antiretroviral agents can compete with zidovudine in the market[5].

Competitive Landscape

The zidovudine market is characterized by a competitive landscape involving several key players:

• GSK: One of the major manufacturers of zidovudine, known for its extensive product portfolio and global reach[1].
• Strides Shasun Limited: A significant player in the generic pharmaceutical market, offering affordable zidovudine formulations[1].
• ViiV Healthcare: A leader in HIV treatment, offering a range of antiretroviral therapies, including those that include zidovudine[1].
• Cipla Ltd: A prominent generic pharmaceutical company with a strong presence in emerging markets[1].

Financial Performance

The financial performance of the zidovudine market is robust, driven by consistent demand and expanding market reach:

• Revenue Growth: The market is expected to grow from $1.1 billion in 2023 to $1.68 billion by 2032, indicating a steady revenue stream[4].
• Product Pricing: The pricing of zidovudine varies by region and formulation. Generic versions are generally more affordable, contributing to higher sales volumes in price-sensitive markets[1].
• Investment and Funding: Significant investments are being made in research and development to improve the efficacy and safety of zidovudine, as well as to develop new combination therapies[3].

Market Outlook

The market outlook for zidovudine remains positive, driven by several factors:

• Porter's 5 Forces Analysis: The market is influenced by factors such as the bargaining power of buyers, the threat of new entrants, and the competitive rivalry among existing players. These forces shape the market dynamics and influence strategic decisions[1].
• Value Chain Analysis: The value chain for zidovudine involves various stages from manufacturing to distribution. Efficient management of this chain is crucial for maintaining market competitiveness[1].
• Pricing Analysis: Pricing strategies play a critical role in the zidovudine market. Companies must balance profitability with affordability to ensure widespread access to the drug[1].

Regulatory Environment

The regulatory environment significantly impacts the zidovudine market:

• Approval Processes: Regulatory approvals are essential for the launch of new formulations or combination therapies. Stringent regulatory standards ensure the safety and efficacy of zidovudine products[1].
• Patent Expirations: The expiration of patents for branded zidovudine products has led to the entry of generic versions, increasing market competition and reducing prices[1].

Emerging Trends

Several emerging trends are shaping the future of the zidovudine market:

• Personalized Medicine: There is a growing interest in personalized treatment regimens that take into account individual patient characteristics and genetic profiles[3].
• Combination Therapies: The development of combination therapies that include zidovudine with other antiretrovirals is a key trend. These combinations offer improved efficacy and reduced side effects[5].

Conclusion

The zidovudine market is characterized by robust growth, driven by increasing demand for antiretroviral therapies and advancements in treatment regimens. Despite challenges such as side effects and resistance, the market is expected to continue growing, driven by a competitive landscape and favorable market dynamics.

Key Takeaways

• The global zidovudine market is projected to grow from $1.1 billion in 2023 to $1.68 billion by 2032.
• The market is segmented by type, application, and geography.
• Key drivers include the increasing prevalence of HIV/AIDS and advancements in treatment regimens.
• Challenges include side effects, resistance, and competition from alternative therapies.
• Major players include GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd.
• The market outlook is positive, driven by favorable market dynamics and emerging trends.

FAQs

Q: What is the current market size of the zidovudine market? A: As of 2023, the global zidovudine market size is approximately $1.1 billion[4].

Q: What is the projected growth rate of the zidovudine market? A: The market is expected to grow at a CAGR of around 4-5% from 2023 to 2032[4].

Q: What are the main side effects associated with zidovudine? A: Zidovudine is associated with side effects such as bone marrow cytotoxicities, anemia, and neutropenia[3].

Q: Which companies are major players in the zidovudine market? A: Key players include GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd[1].

Q: What are the emerging trends in the zidovudine market? A: Emerging trends include personalized medicine and the development of combination therapies that include zidovudine with other antiretrovirals[3][5].

Sources

1. Market Research Intellect - Global Lamivudine and Zidovudine Market Size, Trends and Forecasts Report.
2. PMC - Development of an Optimized Dose for Coformulation of Zidovudine.
3. IMARC Group - Zidovudine Prices, News, Chart, Analysis and Demand.
4. Oxford Academic - Abacavir versus Zidovudine Combined with Lamivudine and Efavirenz.
5. Market Research Intellect - Global Lamivudine and Zidovudine Market Report.