TELBIVUDINE - Generic Drug Details

What are the generic sources for telbivudine and what is the scope of freedom to operate?

Telbivudine is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for telbivudine.

Summary for TELBIVUDINE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	83
Patent Applications:	5,002
DailyMed Link:	TELBIVUDINE at DailyMed

Recent Clinical Trials for TELBIVUDINE

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

Sponsor	Phase
Mahidol University	Phase 4
Lai Wei	Phase 2
Beijing Ditan Hospital	Phase 4

See all TELBIVUDINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TELBIVUDINE

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 TELBIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006		DISCN	Yes	No
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009		DISCN	No	No

Expired US Patents for TELBIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,566,344
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006	7,589,079
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006	6,395,716
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,395,716

EU/EMA Drug Approvals for TELBIVUDINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Sebivo	telbivudine	EMEA/H/C/000713 Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.Initiation of Sebivo 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.	Withdrawn	no	no	no	2007-04-24

Telbivudine Market Dynamics and Financial Trajectory

Overview of Telbivudine

Telbivudine, a synthetic thymidine nucleoside analog, is specifically designed to treat chronic hepatitis B virus (HBV) infections. It works by inhibiting HBV DNA polymerase, thereby terminating viral DNA synthesis and replication[4].

Market Size and Projections

The telbivudine market has been valued at USD 80 million in 2023 and is projected to grow to USD 106.66 million by 2031, with a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031. This growth is driven by several key factors[1].

Drivers of Market Growth

Efficacy and Preference

Telbivudine is preferred by both treatment-naive and treatment-experienced patients due to its high efficacy in inhibiting HBV replication. Its effectiveness compared to other antiviral medications is a significant driver of its market growth[1].

Increasing Prevalence of HBV

The rising global prevalence of chronic HBV infections, particularly in regions like Asia and Africa, increases the demand for potent antiviral medications like telbivudine. This trend is expected to continue, supporting market expansion[1].

Regulatory Approvals and Recommendations

Positive regulatory approvals and recommendations that position telbivudine as a first-line therapy option further boost its market penetration. Regulatory support enhances its credibility and adoption among healthcare providers[1].

Healthcare Infrastructure and Spending

Global investments in healthcare infrastructure and increasing healthcare spending are crucial for the market's growth. These factors facilitate better access to and affordability of telbivudine, contributing to its market trajectory[1].

Market Segmentation

The telbivudine market is segmented based on several criteria:

Type

The market is divided into tablets and capsules, with each form having its own market share and growth prospects[1].

Application

Telbivudine is used in various applications, including chronic hepatitis B treatment, liver cirrhosis prevention, antiviral therapy, and hepatology. Each application segment has its own market dynamics and growth potential[1].

Geography

The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Regional variations in healthcare policies, patient demographics, and economic conditions influence the market size and growth in each region[1].

Competitive Landscape

The telbivudine market features a mix of established and emerging players. Key companies profiled in the market include Novartis AG, Teva Pharmaceutical Industries Ltd., Apotex Inc., Alvogen, Mylan N.V., Lupin Limited, Hetero Drugs Ltd., Dr. Reddy's Laboratories Ltd., Sun Pharmaceutical Industries Ltd., and Aurobindo Pharma Ltd. These companies are categorized based on the types of products they offer and various market-related factors[1].

Clinical and Therapeutic Aspects

Mechanism of Action

Telbivudine works by inhibiting HBV DNA polymerase through the formation of its active metabolite, telbivudine 5'-triphosphate, which competes with the natural substrate thymidine 5'-triphosphate, leading to the termination of viral DNA synthesis[4].

Clinical Efficacy

Studies have shown that telbivudine is effective in reducing HBV DNA levels. For instance, an HBsAg decline of ≥1.0 log10 IU/mL at months 12 of telbivudine therapy is a significant indicator of its efficacy[5].

Safety and Tolerance

Telbivudine is known for its good tolerance and lack of toxicity. It has no dose-limiting side effects and is not a substrate or inhibitor of the cytochrome P450 (CYP450) enzyme system. The drug is primarily eliminated through urinary excretion of the unchanged drug[4].

Market Challenges

Economic Factors

Despite its efficacy, telbivudine was withdrawn from the U.S. market in 2016 primarily due to economic reasons. This highlights the importance of economic viability in sustaining market presence[3].

Competition from Other Antivirals

The market for HBV treatments is competitive, with other antivirals like tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) also being widely used. These alternatives can impact the market share of telbivudine[2].

Future Prospects

Research and Development

Ongoing research into combination therapies and clinical trials is expected to enhance the market prospects of telbivudine. Improvements in formulation and patient-friendly dose regimens are also anticipated to boost its adoption[1].

Global Health Initiatives

Increasing global efforts to combat HBV infections, coupled with rising healthcare spending and awareness, will continue to drive the demand for effective antiviral medications like telbivudine.

Key Takeaways

• The telbivudine market is projected to grow from USD 80 million in 2023 to USD 106.66 million by 2031.
• The market growth is driven by the drug's efficacy, increasing HBV prevalence, regulatory approvals, and global healthcare spending.
• The market is segmented by type, application, and geography.
• Key players include major pharmaceutical companies, and the competitive landscape is influenced by clinical efficacy, safety, and economic factors.
• Ongoing research and global health initiatives are expected to further boost the market.

FAQs

What is the primary use of telbivudine?

Telbivudine is primarily used for the treatment of chronic hepatitis B virus (HBV) infections.

Why was telbivudine withdrawn from the U.S. market in 2016?

Telbivudine was withdrawn from the U.S. market in 2016 largely due to economic reasons.

How does telbivudine work?

Telbivudine works by inhibiting HBV DNA polymerase through the formation of its active metabolite, telbivudine 5'-triphosphate, which competes with the natural substrate thymidine 5'-triphosphate.

What are the key drivers of the telbivudine market?

Key drivers include the drug's efficacy, increasing HBV prevalence, positive regulatory approvals, and global healthcare spending.

Which companies are major players in the telbivudine market?

Major players include Novartis AG, Teva Pharmaceutical Industries Ltd., Apotex Inc., Alvogen, Mylan N.V., and others.

Sources

1. Market Research Intellect, "Global Telbivudine Market Size and Projections", October 2024.
2. FDA, "Clinical Review of Vemlidy (Tenofovir Alafenamide)", January 11, 2016.
3. NCBI Bookshelf, "Telbivudine - LiverTox", October 20, 2020.
4. DrugBank, "Telbivudine: Uses, Interactions, Mechanism of Action".
5. Oxford Academic, "Trajectories and Decline of Serum Hepatitis B Surface Antigen", November 27, 2024.