Adefovir dipivoxil - Generic Drug Details

What are the generic drug sources for adefovir dipivoxil and what is the scope of freedom to operate?

Adefovir dipivoxil is the generic ingredient in two branded drugs marketed by Apotex, Sigmapharm Labs Llc, and Gilead, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for adefovir dipivoxil. Two suppliers are listed for this compound.

Summary for adefovir dipivoxil

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	81
Patent Applications:	6,040
Drug Prices:	Drug price trends for adefovir dipivoxil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adefovir dipivoxil
What excipients (inactive ingredients) are in adefovir dipivoxil?	adefovir dipivoxil excipients list
DailyMed Link:	adefovir dipivoxil at DailyMed

See drug prices for adefovir dipivoxil

Recent Clinical Trials for adefovir dipivoxil

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

Sponsor	Phase
Lai Wei	Phase 2
New Discovery LLC	Phase 4
Taipei Veterans General Hospital, Taiwan	Phase 4

See all adefovir dipivoxil clinical trials

Pharmacology for adefovir dipivoxil

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for adefovir dipivoxil

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

Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEPSERA	Tablets	adefovir dipivoxil	10 mg	021449	1	2010-06-08

US Patents and Regulatory Information for adefovir dipivoxil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ADEFOVIR DIPIVOXIL	adefovir dipivoxil	TABLET;ORAL	205459-001	Jul 6, 2018	AB	RX	No	No
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002		DISCN	Yes	No
Sigmapharm Labs Llc	ADEFOVIR DIPIVOXIL	adefovir dipivoxil	TABLET;ORAL	202051-001	Aug 29, 2013	AB	RX	No	Yes

Expired US Patents for adefovir dipivoxil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002

EU/EMA Drug Approvals for adefovir dipivoxil

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Hepsera	adefovir dipivoxil	EMEA/H/C/000485 Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.	Withdrawn	no	no	no	2003-03-06

Adefovir dipivoxil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adefovir Dipivoxil

Introduction

Adefovir dipivoxil, an antiviral medication, has been a significant player in the treatment of chronic hepatitis B virus (HBV) infection. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its efficacy, market performance, and cost-effectiveness.

Efficacy and Clinical Outcomes

Adefovir dipivoxil has demonstrated strong efficacy in clinical trials. A Phase III study by Gilead Sciences showed that treatment with adefovir dipivoxil 10 mg once daily for 48 weeks resulted in significant improvements in liver histology in 64% of patients, compared to 33% in the placebo group[2].

Liver Histology and Viral Load

The drug has been associated with a median reduction in HBV DNA levels of 3.91 log10 copies/mL, significantly better than the placebo group. Additionally, improvements in liver histology, defined by a reduction in the Knodell necro-inflammatory score and no worsening in the fibrosis score, were observed in a substantial proportion of patients[2].

Resistance Profile

A key advantage of adefovir dipivoxil is its low resistance profile. Preliminary genotypic analyses from clinical studies have shown no adefovir resistance mutations after 48 weeks of treatment, confirming its role as a reliable treatment option for chronic HBV infection[2].

Market Performance

The market for adefovir dipivoxil is growing steadily, driven by the increasing prevalence of chronic hepatitis B and the need for effective antiviral therapies.

Market Size and Forecast

The global adefovir dipivoxil market is expected to gain significant shares in the forecasted period, indicating a strong demand for this medication. Market research reports suggest that the market is growing at a good pace, driven by the expanding patient base and advancements in healthcare infrastructure[4].

Competitive Landscape

Adefovir dipivoxil competes with other antiviral drugs such as lamivudine and pegylated interferon alfa-2a. However, its unique efficacy profile and low resistance rate make it a preferred option for many patients and healthcare providers. The competitive landscape is dynamic, with ongoing research and development aimed at improving treatment outcomes for chronic HBV infection[5].

Cost-Effectiveness Analysis

The cost-effectiveness of adefovir dipivoxil is a crucial factor in its market dynamics.

Cost Comparison

Studies have shown that while adefovir dipivoxil is more expensive than lamivudine, it offers better virological response rates. For example, a cost-effectiveness analysis over a 4-year period found that the total estimated cost per patient treated with adefovir dipivoxil was $21,939, compared to $11,457 for lamivudine. However, the virological response rate at year 4 was 78.0% for adefovir dipivoxil, significantly higher than the 40.4% for lamivudine[3].

Incremental Cost-Effectiveness Ratio (ICER)

The ICER for adefovir dipivoxil compared to lamivudine has been calculated to be around $27,872 per additional responding patient, indicating that while it is more costly, it provides better treatment outcomes. This makes it a cost-effective strategy, especially in the long term[3].

Quality-Adjusted Life Years (QALYs)

A comprehensive cost-effectiveness analysis using a Markov model found that adefovir dipivoxil generated the most life-years, although at higher costs. The incremental cost per QALY for adefovir dipivoxil compared to lamivudine was within the range considered good value for money by healthcare decision-makers[5].

Safety Profile

The safety profile of adefovir dipivoxil is another critical factor influencing its market dynamics.

Adverse Events

Clinical trials have shown that the discontinuation rate due to adverse events is low for adefovir dipivoxil. The incidence of grade 3 and 4 laboratory abnormalities and clinical adverse events was similar between the treatment and placebo arms, indicating a favorable safety profile[2].

Renal Function

Adefovir dipivoxil has been monitored for its impact on renal function, and no significant changes in serum creatinine or phosphorus levels were observed, confirming its safety in this regard[2].

Regulatory and Approval Status

Adefovir dipivoxil has undergone rigorous regulatory scrutiny and has been approved for use in various regions.

Regulatory Filings

Gilead Sciences has completed regulatory filings in the United States and Europe, based on extensive safety and efficacy data accumulated from clinical trials. This regulatory approval has been a significant milestone in the drug's market trajectory[2].

Patient and Healthcare Provider Perspectives

The perspectives of patients and healthcare providers play a crucial role in the market dynamics of adefovir dipivoxil.

Patient Outcomes

Patients infected with precore mutant HBV, who often experience poor clinical outcomes, have shown significant improvements with adefovir dipivoxil treatment. This has enhanced patient satisfaction and adherence to treatment[2].

Healthcare Provider Confidence

Healthcare providers have expressed confidence in adefovir dipivoxil due to its efficacy and safety profile. Professor Stephanos Hadziyannis, MD, noted that the results from clinical studies demonstrate that adefovir dipivoxil may provide a promising treatment option for patients with chronic HBV infection[2].

Future Outlook

The future outlook for adefovir dipivoxil is promising, driven by ongoing research and the growing need for effective antiviral therapies.

Ongoing Research and Development

Continuous research is aimed at improving treatment outcomes and reducing resistance rates. New treatment strategies, such as combination therapies, are being explored to further enhance the efficacy of adefovir dipivoxil[5].

Expanding Market Reach

The market for adefovir dipivoxil is expected to expand as healthcare access improves globally. Increasing awareness about chronic HBV infection and the importance of antiviral treatment will drive demand for this medication[4].

Key Takeaways

• Efficacy: Adefovir dipivoxil has shown significant improvements in liver histology and viral load reduction.
• Market Performance: The global market is growing, driven by the increasing prevalence of chronic HBV and the drug's unique efficacy profile.
• Cost-Effectiveness: Despite higher costs, adefovir dipivoxil offers better treatment outcomes, making it a cost-effective strategy in the long term.
• Safety Profile: The drug has a favorable safety profile with low discontinuation rates due to adverse events.
• Regulatory Approval: Adefovir dipivoxil has been approved in various regions based on extensive safety and efficacy data.
• Future Outlook: Ongoing research and expanding market reach are expected to drive the drug's market dynamics.

FAQs

What is the primary use of adefovir dipivoxil?

Adefovir dipivoxil is primarily used for the treatment of chronic hepatitis B virus (HBV) infection.

How effective is adefovir dipivoxil in improving liver histology?

Adefovir dipivoxil has been shown to improve liver histology in 64% of patients after 48 weeks of treatment, compared to 33% in the placebo group[2].

Is adefovir dipivoxil cost-effective compared to other antiviral drugs?

Yes, despite being more expensive, adefovir dipivoxil offers better virological response rates and is considered cost-effective in the long term, with an incremental cost-effectiveness ratio that is within the range considered good value for money[3][5].

What is the safety profile of adefovir dipivoxil?

Adefovir dipivoxil has a favorable safety profile with low discontinuation rates due to adverse events and no significant changes in renal function markers[2].

Has adefovir dipivoxil been approved by regulatory authorities?

Yes, adefovir dipivoxil has been approved for use in various regions based on extensive safety and efficacy data accumulated from clinical trials[2].

What is the future outlook for the market of adefovir dipivoxil?

The market for adefovir dipivoxil is expected to grow, driven by ongoing research, expanding market reach, and the growing need for effective antiviral therapies[4].

Sources

1. The Insight Partners - Adefovir Dipivoxil Market Key Findings by 2031.
2. Gilead Sciences - Gilead Sciences Announces Results From Phase III Study of Adefovir Dipivoxil in Precore Mutant Chronic Hepatitis B Virus Infection.
3. PubMed - Cost-effectiveness analysis of lamivudine and adefovir dipivoxil in patients with hepatitis B 'e' antigen-negative chronic hepatitis B.
4. Market Research Intellect - Global Adefovir Dipivoxil Market Size And Forecast.
5. PubMed - Adefovir dipivoxil and pegylated interferon alfa-2a for the treatment of adults with chronic hepatitis B infection (CHB).