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:	5,305
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
Shanghai Zhimeng Biopharma, Inc.	Phase 2
Tigermed Consulting Co., Ltd	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	5,908,638

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
Austria	157095
Australia	634423
Australia	8559891
Brazil	1100846
Canada	2053339	HYDROXYMETHYL(METHYLENECYCLOPENTYL) PURINES ET PYRIMIDINES (HYDROXYMETHYL(METHYLENECYCLOPENTYL) PURINES AND PYRIMIDINES)

Supplementary Protection Certificates for BARACLUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481754	CA 2006 00033	Denmark
0481754	06C0040	France		PRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
0481754	91275	Luxembourg		CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 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
0481754	C00481754/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH

BARACLUDE (entecavir) market dynamics and financial trajectory (U.S., key ex-U.S. markets, and IP-driven pricing risks)

Last updated: June 24, 2026

Executive summary

• Baraclude (entecavir) is a first-line oral nucleoside analog for chronic hepatitis B (CHB). Core demand is driven by guideline-aligned suppression of HBV DNA, high genetic-barrier positioning versus lamivudine, and long treatment durations in real-world care.
• Sales have moderated from earlier growth phases as generic entecavir entered in the U.S. and competition broadened in multiple markets. The remaining economic upside is concentrated in brand-protected geographies (where applicable), switching inertia, and managed access pricing.
• Financial trajectory is most sensitive to: (1) U.S. and EU generic penetration timing and share, (2) reimbursement pressure and tender dynamics in ex-U.S. markets, (3) safety and resistance narratives that influence prescriber selection, and (4) any incremental share gains through expanded line-of-therapy use (treatment-naïve and resistant settings).
• The long-term market outlook is constrained by a mature CHB standard-of-care landscape and continuous generic pricing compression, with growth typically limited to population growth and guideline-based treatment rates rather than product differentiation.

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How has Baraclude performed financially vs peers in chronic hepatitis B?

Baraclude competes in a crowded CHB market dominated by nucleos(t)ide analogs, with switching patterns shaped by resistance history, renal monitoring needs, and access pricing. Entecavir historically maintained share through:

• Rapid viral suppression and durability relative to older nucleosides.
• A high genetic barrier compared with lamivudine.
• Clinician familiarity and established treatment workflows.

Peer set commonly used in commercial benchmarking

• Tenofovir disoproxil fumarate (Viread, generics)
• Tenofovir alafenamide (Vemlidy)
• Lamivudine (generic)
• Adefovir dipivoxil (less used)
• Interferon-alfa and peginterferon options (less dominant in routine practice now)

Commercial impact from competitive set

• Tenofovir-based regimens increased class-wide demand capture, especially where renal/bone tolerability management supported earlier switch decisions.
• Entecavir continues to retain a role for patients needing an alternative to tenofovir or where formularies favor entecavir.

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What market dynamics drive Baraclude demand in chronic hepatitis B?

Demand is functionally “chronic and stable” but monetization is “contract and price sensitive.”

Guideline alignment and line-of-therapy

• Baraclude is typically positioned for chronic hepatitis B requiring long-term suppression, including treatment-naïve patients in some systems.
• Entecavir also has a role in patients with prior nucleoside exposure, subject to local resistance and guideline language.

Resistance and switching behavior

• Prescribers value resistance profiles when choosing between nucleos(t)ide analogs. Entecavir has a distinct place versus lamivudine failure, while tenofovir often gains share due to low resistance rates and clinical outcomes data.
• Switching from entecavir to tenofovir can occur when clinicians perceive improved tolerability or when patient comorbidities shift benefit-risk.

Reimbursement pressure

• As generics dominate, payers push toward lowest-cost options in formularies and tenders.
• In systems with strong tendering or reference pricing, brand economics compress quickly unless a brand is locked into preference contracts.

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When did generics reduce Baraclude pricing power in the U.S., and how does that affect revenue trajectory?

U.S. economics for entecavir moved from brand-led pricing to generic price competition. The resulting pattern is typical:

• Volume persists because entecavir is still guideline-relevant.
• Revenue declines because branded pricing is replaced by low-cost generics and payer substitution.

Mechanism of revenue compression

• Immediate competitive entry drives rapid formulary substitution.
• Subsequent generic waves intensify price pressure, especially in high-volume dosage strengths.

Net effect on financial trajectory

• The trajectory shifts from “brand growth” to “mature, maintenance sales” with limited ability to re-inflate pricing.
• Any brand retention depends on managed access, physician preference persistence, and specific payer exceptions.

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What is the global competitive landscape for entecavir, and how do regional tendering and reimbursement patterns differ?

High tendering markets

• Where national or state tendering is common, unit price tends to track winner-take-most dynamics.
• Entecavir generics generally participate as interchangeable options, limiting brand premium.

Payer formularies with tiering

• If formularies retain multiple nucleos(t)ide options, share can split by renal monitoring protocols and patient comorbidity considerations.
• In these systems, entecavir can sustain share even after generic entry, though brand unit price erosion is still substantial.

Prescriber behavior as a stabilizer

• Even in competitive markets, long treatment horizons mean switching is often incremental.
• Patients stable on entecavir may remain on therapy unless a clear clinical driver arises.

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How do resistance risk, renal monitoring, and tolerability narratives affect Baraclude market share?

CHB prescribing is increasingly risk-managed. Key drivers:

• Renal function monitoring is central to treatment choices across nucleos(t)ide analogs.
• Clinician comfort with monitoring protocols can support entecavir use when tenofovir switching is delayed or avoided.
• Safety narratives influence retention: stable lab results often reduce willingness to switch drugs.

Commercial implication

• Entecavir can gain share in subpopulations where clinicians prefer an alternative framework to tenofovir-based regimens.
• Tenofovir alafenamide has expanded share capture where tolerability concerns or switching benefit exist.

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What share gains or losses has Baraclude experienced from switching between entecavir and tenofovir regimens?

Market switching typically follows one of two patterns:

1. Cost-driven switching: payers and formularies drive substitution toward the preferred cheapest option.
2. Clinical switching: tolerability and comorbidity management drives individualized choice.

Commercial effect

• Tenofovir-based regimens have repeatedly increased their footprint where payer contracting favors them or where clinicians prefer their long-term safety narrative.
• Entecavir can retain pockets of demand where switching is not prioritized or where resistance history makes clinicians maintain current suppression strategy.

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What commercial bottlenecks limit future upside for Baraclude?

1) Generic interchangeability

• Entecavir’s core value is antiviral efficacy rather than unique delivery technology.
• Once multiple generic entrants establish low price points, premium pricing becomes structurally difficult.

2) Mature CHB market saturation

• The CHB treatment pool is established and requires ongoing therapy rather than net-new therapy creation at high rates.
• Growth is typically tied to incidence and guideline uptake rather than product innovation cycles.

3) Competitive switching incentives

• Tenofovir regimens and newer options create ongoing pressure on entecavir share.
• Even when entecavir remains clinically appropriate, prescribers face strong access and payer nudges.

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How does patent and regulatory status shape Baraclude pricing and market access?

Baraclude is a mature product with generic competition in the U.S. and many other markets. Patent-driven pricing power has largely transitioned to generic pricing in jurisdictions where exclusivity barriers have lapsed.

Orange Book status and generic entry risk (U.S.)

• When branded entecavir faced generic entry, the commercial outcome was classic: rapid revenue erosion after substitution.
• For branded economics, the key variable is the timing of effective patent expiration and any settlement terms that delay entry.

Regulatory competition

• FDA-approved generics and follow-on approvals generally normalize access.
• The market’s pricing elasticity is high once substitution is enabled.

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What is the likely revenue profile: branded vs generic economics for entecavir in CHB?

A mature entecavir portfolio typically exhibits:

• Branded: declining long-run revenue as price benchmarks compress and payer coverage favors generics.
• Generic market: stable or growing volumes with low margins per unit.
• Residual brand lift (where present): retention in niche contracts or where substitution is slower.

Financial trajectory (structural)

• Expect a downward shift in top-line revenue attributable to brand pricing compression rather than demand collapse.
• Volume may stabilize; revenue does not.

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Which dose forms and patient segments matter most to Baraclude revenue?

Dose forms

• Baraclude is an oral tablet product across typical CHB dosing regimens. Commercially, unit demand is concentrated in the standard dose strengths used in routine care.

Patient segments

• Treatment-naïve CHB: share depends on guideline implementation and payer formulary.
• Previously treated/resistance management: entecavir can remain relevant where clinicians need a strategy aligned with resistance patterns.
• Comorbidity-driven choices: patients with renal/bone considerations may steer prescribing toward specific analogs.

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How does Baraclude compare with Vemlidy (tenofovir alafenamide) in market positioning and financial exposure?

Positioning

• Entecavir: high genetic barrier narrative and mature clinical familiarity.
• Vemlidy: often captures patients where tolerability and long-term safety narratives support earlier adoption and retention.

Financial exposure

• Entecavir faces direct price compression via generic substitution.
• Vemlidy’s market is more insulated from direct generic price competition in many jurisdictions due to regulatory and exclusivity structures that, in practice, sustain premium pricing for longer.

Net effect

• Entecavir’s financial upside relies more on persistence within formularies and clinical preference inertia.
• Vemlidy’s upside benefits from premium access and slower pricing normalization in the period before generic competition.

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What is the downside risk profile for Baraclude: pricing pressure vs demand destruction?

Baraclude’s primary downside is pricing compression, not regimen obsolescence. Key risks:

• Further increases in generic competitive intensity.
• Payer consolidation of formularies to single-preferred nucleos(t)ide options.
• Expanded tenofovir alafenamide preferences that reduce entecavir switching retention.

Demand destruction risk is lower

• CHB therapy duration is long and many patients remain stable on existing suppression regimens.
• Switching is often clinically justified rather than purely convenience-driven.

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Key takeaways

• Baraclude’s market dynamics fit a mature CHB pattern: stable volume with revenue compression once generics dominate.
• The brand’s financial trajectory is primarily governed by U.S. and ex-U.S. reimbursement structures and payer substitution speed, not by clinical disqualification.
• Future upside is constrained by interchangeable generic entry and ongoing share pressure from tenofovir-based regimens, especially Vemlidy where premium positioning persists.
• The biggest “swing factor” for financial outcomes is not new patient creation, but contract pricing and formulary retention across large reimbursement geographies.

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FAQs

1. How does payer substitution typically change entecavir branded-to-generic mix in chronic hepatitis B?
2. What clinical factors cause physicians to keep patients on entecavir rather than switching to tenofovir alafenamide?
3. Which countries tend to adopt the fastest reference pricing or tendering for older CHB drugs like entecavir?
4. How sensitive is entecavir market share to guideline updates that emphasize different nucleos(t)ide sequencing?
5. What are the most common triggers for entecavir-to-tenofovir switching in real-world CHB management?

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References

1. FDA. Drugs@FDA: Baraclude (entecavir). U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. American Association for the Study of Liver Diseases (AASLD) guidelines for management of chronic hepatitis B (latest current guideline text).
4. European Association for the Study of the Liver (EASL) clinical practice guidelines: Chronic hepatitis B (latest current guideline text).

DrugChatter Q&A for BARACLUDE

How does Baraclude treat chronic Hep B?