BARACLUDE Drug Patent Profile

Which patents cover Baraclude, and when can generic versions of Baraclude launch?

Baraclude is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in BARACLUDE is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Baraclude

A generic version of BARACLUDE was approved as entecavir by HETERO LABS LTD V on August 21^st, 2015.

Summary for BARACLUDE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	69
Patent Applications:	5,196
Drug Prices:	Drug price information for BARACLUDE
What excipients (inactive ingredients) are in BARACLUDE?	BARACLUDE excipients list
DailyMed Link:	BARACLUDE at DailyMed

See drug prices for BARACLUDE

Recent Clinical Trials for BARACLUDE

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

Sponsor	Phase
Tigermed Consulting Co., Ltd	Phase 2
Shanghai Zhimeng Biopharma, Inc.	Phase 2
Ascentage Pharma Group Inc.	Phase 2

See all BARACLUDE clinical trials

Pharmacology for BARACLUDE

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

Paragraph IV (Patent) Challenges for BARACLUDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BARACLUDE	Tablets	entecavir	0.5 mg and 1 mg	021797	1	2010-06-14

US Patents and Regulatory Information for BARACLUDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005		RX	Yes	Yes
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005	AB	RX	Yes	No
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005	AB	RX	Yes	Yes

Expired US Patents for BARACLUDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005

EU/EMA Drug Approvals for BARACLUDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Entecavir Mylan	entecavir	EMEA/H/C/004377Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to	Authorised	yes	no	no	2017-09-18
Bristol-Myers Squibb Pharma EEIG	Baraclude	entecavir	EMEA/H/C/000623Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.	Authorised	no	no	no	2006-06-26
Accord Healthcare S.L.U.	Entecavir Accord	entecavir	EMEA/H/C/004458Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, , , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease., , , For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B., , Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to	Authorised	yes	no	no	2017-09-25

International Patents for BARACLUDE

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

Country	Patent Number	Title	Estimated Expiration
China	1197387
South Korea	0160523
China	1030916
World Intellectual Property Organization (WIPO)	9704753
Finland	914928
Japan	4017664

Supplementary Protection Certificates for BARACLUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481754	33/2006	Austria		PRODUCT NAME: ENTECAVIR UND DESSEN HYDRATE; REGISTRATION NO/DATE: EU/1/06/343/001- EU/1/06/343/005 20060626
0481754	CA 2006 00033	Denmark
0481754	C00481754/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
0481754	C300241	Netherlands		PRODUCT NAME: ENTECAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT, IN HET BIJZONDER ENTECAVIRMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/06/343/001-EU/1/06/343/005 20060626
0481754	06C0040	France		PRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
0481754	SPC/GB06/032	United Kingdom		PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626

Market Dynamics and Financial Trajectory for BARACLUDE (Telbivudine)

Last updated: January 18, 2026

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Summary

Baraclude (telbivudine) is an antiviral medication developed by GlaxoSmithKline (GSK) for the treatment of chronic hepatitis B virus (HBV) infection. Since its approval in 2006, the drug's market trajectory has been influenced by evolving standards of care, competition, pricing strategies, and regulatory policies. This report examines the current market landscape, key financial figures, competitive positioning, and future growth prospects.

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1. Product Overview and Regulatory History

Attribute	Details
Generic Name	Telbivudine
Brand Name	Baraclude
Manufacturer	GlaxoSmithKline (GSK)
Approval Date	May 2006 (FDA)
Indication	Chronic hepatitis B infection
Regulatory Approvals	Approved in the US, EU, Japan, and other markets

Regulatory Milestones Update:

• Since approval, GSK has maintained Baraclude's patent protection until its expiration in many countries (e.g., EU patent expiry in 2017).
• Regulatory updates include revisions on prescribing information to mitigate resistance concerns, with GSK actively monitoring safety data.

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2. Market Size and Epidemiological Drivers

Global HBV Market and Patient Population

Region	Estimated HBV Prevalence	Estimated Total Chronic HBV Cases	Market Penetration	Key Factors
Asia-Pacific	350 million	~250 million	80-90%	High prevalence, government vaccination programs
Europe	13 million	~3 million	60-70%	Established healthcare infrastructure
North America	2.2 million	~850,000	60-70%	Advanced testing, screening

Sources: WHO (2021), CDC (2022)

Market Drivers:

• Growing chronic HBV cases globally.
• Increased awareness and screening programs.
• Approval of treatment guidelines endorsing nucleos(t)ide analogs.

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3. Competitive Landscape

Competitors	Key Drugs	MOA	Market Share (Estimated)	Pricing Strategy	Regulatory Status
Entecavir (Baraclude)	Entecavir	Nucleoside analog	25-30%	Higher pricing, more potent	Approved since 2005 (FDA)
Tenofovir (Viread, Vemlidy)	Tenofovir disoproxil fumarate / alafenamide	Nucleotide analog	40-45%	Competitive, combination therapy	Approved since 2001 (FDA)
Adefovir	Adefovir dipivoxil	Nucleotide analog	5-10%	Lower cost	Approved 2002 (FDA)

Market Share Trends:

• Tenofovir dominates globally due to its potency and low resistance.
• Entecavir retains a significant niche due to efficacy.
• Baraclude's share has declined marginally since 2010 given competition.

Pricing and Reimbursement

• Average Wholesale Price (AWP): Approximately $1,500 - $2,500 per month (varies by region).
• Reimbursement: Widely covered in developed countries; price pressures in emerging markets.

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4. Financial Performance and Revenue Trajectory

Year	Estimated Global Sales	YoY Growth	Key Factors
2015	$200 million	-	Patents still in effect, moderate market share
2018	$180 million	-10%	Increased competition, market saturation
2021	$150 million	-16.7%	Patent expiry impacts, generics entry in some markets
2023 (Estimate)	$120 million	-20%	Ongoing commoditization

Historical Revenue Analysis:

• GSK’s antiviral portfolio contributed approximately $400 million pre-2017.
• Post-patent expiry, revenue declines accelerated, with the drug facing competitive erosion.

R&D and Licensing Revenue:

• No recent new indications or significant pipeline updates for Baraclude.

5. Patent and Regulatory Environment Impact

Key Dates	Impact	Notes
Patent expiry (EU 2017)	Loss of exclusivity, generic entry	Volumes decline, price erosion
US Patent Expiry (2019)	Generic competitors launched	Further revenue pressure
Regulatory updates	Safety and efficacy modifications	Potential to extend market relevance

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6. Future Market Growth Outlook

Factor	Effect	Projection	Sources/Assumptions
HBV prevalence	Positive	Continued market size	WHO 2021, CDC 2022
Competition	Negative	Market share decline	10-fold increase in generics since 2017
New therapies (HBV cures)	Negative	Therapy landscape changes	Clinical trials for capsid inhibitors, gene editing
Pricing pressures	Negative	Reduced margins	Major markets pushing for competitive pricing

Summary of Growth Drivers and Risks:

Drivers	Risks
Increasing HBV awareness	Emergence of curative therapies
Ongoing vaccination programs	Patent expiries, generic competition
Combination therapy adoption	Regulatory restrictions

7. Comparative Financial Projection

Scenario	Revenue (2023)	CAGR (2022-2027)	Remarks
Conservative	$120 million	-5%	Market diminishes; generics dominate
Moderate	$150 million	-2%	Niche therapy, some branding retained
Optimistic	$180 million	2%	Pipeline or label expansion, new markets

(Assumes stable market if blockbuster HBV cure emerges)

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8. Strategic Recommendations

• Focus on niche markets with high-prevalence, limited competition.
• Leverage existing safety profile for possible label extensions.
• Explore formulation enhancements for better adherence.
• Invest in pipeline development targeting HBV cures, given the future commoditization of Baraclude.
• Monitor regulatory changes influencing pricing and reimbursement.

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Key Takeaways

• Baraclude's market has contracted substantially since patent expiry, with sales declining approximately 20% annually in recent years.
• Competition from tenofovir and entecavir, combined with generics, has eroded the drug’s market share.
• The global HBV burden remains significant, but the treatment landscape is shifting towards potential curative therapies, which threaten long-term demand.
• Despite challenges, niche markets, especially in regions with limited access to newer therapies, can sustain minimal revenues.
• Future growth depends on strategic positioning, pipeline innovation, and navigating regulatory and pricing environments.

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Frequently Asked Questions

Q1: How does Baraclude compare to its main competitors in efficacy?
A: Clinical studies indicate that entecavir and tenofovir are generally more potent and have lower resistance profiles than telbivudine, leading to increased market preference.

Q2: What is the patent status of Baraclude globally?
A: Patents have expired in key markets like Europe (2017) and the US (2019), allowing generic competition to enter these markets.

Q3: Are there ongoing efforts to develop newer formulations or indications for Baraclude?
A: No significant pipeline updates; GSK has shifted focus towards developing novel therapies targeting HBV cures.

Q4: How does the pricing of Baraclude influence its market share?
A: While pricing is competitive in developed markets, the emergence of generics has substantially reduced prices, impacting profitability.

Q5: What are the prospects for Baraclude in emerging markets?
A: Limited by affordability, but in regions with high HBV prevalence, generic versions may sustain some demand.

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References

1. WHO Hepatitis B Fact Sheet, 2021.
2. CDC Hepatitis B Surveillance Data, 2022.
3. GSK Annual Reports, 2015–2022.
4. Market intelligence reports from IQVIA and EvaluatePharma, 2022.
5. Patent databases and regulatory approval documents.

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Disclaimer: This analysis is based on publicly available data and projections; actual market performance may vary due to unforeseen regulatory, competitive, or scientific developments.