TYZEKA Drug Patent Profile

When do Tyzeka patents expire, and what generic alternatives are available?

Tyzeka is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. Additional details are available on the telbivudine profile page.

Summary for TYZEKA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	5
Patent Applications:	3,060
DailyMed Link:	TYZEKA at DailyMed

Recent Clinical Trials for TYZEKA

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

Sponsor	Phase
Chinese University of Hong Kong	N/A
Novartis	Phase 4
Novartis Pharmaceuticals	Phase 3

See all TYZEKA clinical trials

US Patents and Regulatory Information for TYZEKA

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	SOLUTION;ORAL	022154-001	Apr 28, 2009		DISCN	No	No
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006		DISCN	Yes	No

Expired US Patents for TYZEKA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006

EU/EMA Drug Approvals for TYZEKA

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	Withdrawn	no	no	no	2007-04-24

International Patents for TYZEKA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20050083619	CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE
Denmark	2415776
Japan	2002522552
Singapore	132498	BETA-L-2Æ-DEOXY-NUCLEOSIDES FOR THE TREATMENT OF HEPATITIS B
China	1320128
World Intellectual Property Organization (WIPO)	0009531

Supplementary Protection Certificates for TYZEKA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1104436	SZ 39/2007	Austria		PRODUCT NAME: TELBIVUDIN
1104436	300286	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1104436	07C0046	France		PRODUCT NAME: TELBIVUDINE (DC1); REGISTRATION NO/DATE IN FRANCE: EU/1/07/388/001 DU 20070424; REGISTRATION NO/DATE AT EEC: EU/1/07/388/001 DU 20070424
1104436	CA 2007 00038	Denmark		PRODUCT NAME: TELBIVUDINE
1104436	C01104436/01	Switzerland		FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
1104436	39/2007	Austria		PRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424

TYZEKA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Tyzeka

Introduction to Tyzeka

Tyzeka, also known as telbivudine, is a nucleoside analogue reverse transcriptase inhibitor used for the treatment of chronic hepatitis B in adult patients. Here, we will delve into the market dynamics and financial trajectory of Tyzeka, exploring its place in the hepatitis drugs market, its performance, and the factors influencing its success.

Market Size and Growth of Hepatitis Drugs

The global hepatitis drugs market is experiencing significant growth, driven by increasing prevalence of hepatitis B and advancements in treatment options. As of 2023, the global hepatitis drugs market size was substantial, with a compound annual growth rate (CAGR) expected to continue through 2031[1].

Tyzeka's Position in the Market

Tyzeka is one of the key players in the hepatitis B treatment segment. It is indicated for adult patients with chronic hepatitis B and has shown efficacy in clinical trials, particularly in reducing viral load and improving liver function[4].

Regional Analysis

The market for hepatitis drugs, including Tyzeka, is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own market dynamics, with Asia Pacific often being a significant contributor due to the high prevalence of hepatitis B in this area[1].

Financial Performance of Manufacturers

Teva Pharmaceutical Industries, one of the companies involved in the distribution and development of hepatitis drugs, has reported strong financial results. For instance, in 2023, Teva's revenues increased by 6% compared to 2022, driven partly by higher revenues from generic and innovative products. However, specific financial data for Tyzeka is not separately disclosed in Teva's reports, but it is part of the broader portfolio contributing to the company's overall performance[5].

Revenue and Sales

While specific revenue figures for Tyzeka are not provided in the available sources, the drug's sales are included in the overall revenues of companies like Teva. The success of Tyzeka can be inferred from the growing demand for hepatitis B treatments and the company's overall financial health. For example, Teva's revenues from its generic and innovative products have been on the rise, indicating a positive trend for drugs like Tyzeka[5].

Competitive Landscape

The hepatitis drugs market is competitive, with several drugs available for the treatment of hepatitis B, including Tyzeka, VEMLIDY, and EPCLUSA. The market share of Tyzeka is influenced by its efficacy, safety profile, and pricing strategy compared to other treatments. The competitive landscape is dynamic, with new drugs and therapies being developed, which can impact Tyzeka's market position[1].

Clinical Efficacy and Safety

Tyzeka has demonstrated clinical efficacy in treating chronic hepatitis B, with a favorable safety profile. It is administered orally, once daily, and dose adjustments are required for patients with renal impairment. The drug's adverse event profile is generally mild to moderate, with common side effects including dyspepsia, insomnia, and abdominal distension[4].

Regulatory Environment

The approval and postmarketing surveillance of Tyzeka are regulated by health authorities such as the FDA. The FDA's oversight includes ensuring that postmarketing studies are completed to confirm the drug's clinical benefit and safety. This regulatory environment is crucial for maintaining the drug's market presence and ensuring patient safety[3].

Pricing and Access

The pricing of Tyzeka can be a significant factor in its market dynamics. The cost of the drug, along with reimbursement policies and access programs, influences its adoption rate. Companies often negotiate with healthcare providers and insurance companies to ensure better access to their drugs, which can impact revenue and market share[1].

Future Prospects

The future prospects of Tyzeka are tied to the overall growth of the hepatitis drugs market and the drug's ability to maintain its market share. With advancements in treatment options and increasing awareness about hepatitis B, the demand for effective treatments like Tyzeka is expected to continue. However, competition from new drugs and therapies will remain a key challenge.

Key Statistics

• Global Hepatitis Drugs Market Size: Expected to grow significantly through 2031[1].
• Teva's Revenue Growth: 6% increase in 2023 compared to 2022[5].
• Tyzeka Dosage: 600 mg once daily, with dose adjustments for renal impairment[4].
• Common Side Effects: Dyspepsia, insomnia, abdominal distension[4].

Conclusion

Tyzeka is a significant player in the hepatitis B treatment market, with a strong clinical profile and a favorable safety record. Its financial trajectory is closely tied to the overall performance of its manufacturers, such as Teva, and the broader dynamics of the hepatitis drugs market. As the market continues to grow, Tyzeka's success will depend on its ability to compete with other treatments and maintain its market share.

Key Takeaways

• Tyzeka is an effective treatment for chronic hepatitis B with a favorable safety profile.
• The global hepatitis drugs market is growing, driven by increasing prevalence and advancements in treatments.
• Teva's financial performance indicates a positive trend for its portfolio, including Tyzeka.
• Regulatory oversight by health authorities is crucial for maintaining Tyzeka's market presence.
• Pricing and access strategies play a significant role in the drug's adoption rate.

FAQs

What is Tyzeka used for?

Tyzeka is used for the treatment of chronic hepatitis B in adult patients. It is a nucleoside analogue reverse transcriptase inhibitor that helps reduce viral load and improve liver function[4].

How is Tyzeka administered?

Tyzeka is administered orally, once daily, with or without food. Dose adjustments are required for patients with renal impairment[4].

What are the common side effects of Tyzeka?

Common side effects of Tyzeka include dyspepsia, insomnia, abdominal distension, and increased creatine kinase (CK) levels[4].

Who manufactures Tyzeka?

Tyzeka is manufactured and distributed by companies such as Novartis and is part of the broader portfolio of pharmaceutical companies like Teva[4].

What is the current market size of the hepatitis drugs market?

The global hepatitis drugs market size was significant in 2023 and is expected to grow through 2031, driven by increasing prevalence and advancements in treatments[1].

Sources

1. Cognitivemarketresearch.com: Global Hepatitis Drugs Market Report 2024 Edition.
2. Tevapharm.com: Teva Announces Strong Financial Results for the Third Quarter of 2024.
3. GAO.gov: New Drug Approval: FDA Needs to Enhance Its Oversight of Postmarketing Studies.
4. Drugs.com: Tyzeka: Package Insert / Prescribing Information.
5. Tevapharm.com: Teva Reports Growth in Fourth Quarter and Full Year 2023.