EU/EMA Drug Approvals for ENTECAVIR

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

Last updated: June 24, 2026

Entecavir’s commercial position is dominated by long-running, high-barrier chronic hepatitis B (CHB) treatment demand, but its financial trajectory has shifted toward mature-market pricing pressure, retailer and payer formulary optimization, and broader generic penetration in most developed markets. The product’s patent-led brand advantage has largely depended on the strength and remaining term of entecavir small-molecule composition and use protections, alongside regulatory exclusivity (where applicable) and how quickly FDA/EMA generics converted to launch-ready status after Orange Book and marketing-authorisation data transitions.

Below is the investor-grade map of where the money came from, what drove volume and price, and what IP and regulatory conditions determine future cashflow exposure.

What patents protect entecavir (Baraclude) and how strong is the patent estate?

Fast answer: Entecavir is protected by a mature but now largely expired core IP set in many jurisdictions, leaving the brand’s remaining edge to narrower formulation and method-of-use claims (if any remain locally) and to regulatory history rather than new primary composition barriers.

Key IP families typically asserted for entecavir

Entecavir is a known antiviral nucleoside analogue with an established patent landscape that historically covers:

Chemical entity and stereochemical definitions
Pharmaceutical compositions (formulations, salt forms, dosing strengths)
Methods of treatment for HBV
Manufacturing and crystallinity/process details (where claimed)

What to look for in an entecavir patent estate audit

A practical, litigation-ready estate review for entecavir should check, per jurisdiction:

Primary composition claims: active ingredient, tautomers, prodrug forms (if any), and pharmaceutically acceptable salts
Method-of-use claims: CHB patient subsets (HBeAg status, resistance status), HBV DNA suppression targets, ALT thresholds, or combination regimens
Formulation claims: tablet composition ranges, excipients, dissolution profiles
Process claims: crystallisation conditions and batch reproducibility

How “strength” usually manifests for entecavir

For established CHB drugs like entecavir, market reality tends to reflect:

Generic availability after composition term expiry
Settlement-driven or launch-schedule compression when brand-held patents narrow
Brand value persistence driven by switching friction in chronic therapy (patient-specific tolerability and clinician habits), not by a still-dominant patent wall

When does entecavir lose exclusivity and what are the regulatory timelines?

Fast answer: Entecavir’s CHB exclusivity profile is dominated by the original composition patent term and follow-on protection windows that have narrowed over time. Current exclusivity leverage in major markets is generally limited compared with newer HBV agents.

Regulatory exclusivity concepts relevant to entecavir

Entecavir’s exclusivity schedule in the US typically turns on:

Orange Book-listed patents tied to the NDA holder
5-year new chemical entity exclusivity (historically relevant to the first approved product, but already elapsed)
Patent expiry dates controlling Paragraph IV/ANDA leverage

In the EU/UK, commercial protection depends on:

Marketing authorisation history and SPC coverage (if any exists for local claim sets)
National enforcement and validity of composition and use claims

Commercial timing impact

As exclusivity fades, the dominant determinant becomes:

Launch timing of generics and authorized generics (if any)
Tendering and pharmacy benefit manager contracting cycles
Prescriber switching behavior in chronic therapy

What Orange Book listings exist for entecavir and where are the expiry bottlenecks?

Fast answer: Entecavir’s Orange Book posture has historically included multiple patent types, but the key question for financial trajectory is which patents remain listed with the latest expiry dates and whether they are enforceable against ANDA launches.

How to map Orange Book risk to cashflow

For each listed patent on the reference listed drug (RLD):

Identify the patent expiration date (and any terminal disclaimers)
Determine whether patents are composition/use vs formulation/manufacturing
Check typical ANDA challenge pathways (Paragraph IV) that affect launch timing

Financial implication

Orange Book expiry dates determine:

Whether the brand remains protected from immediate ANDA competition
Whether generic entries occur simultaneously or in waves
The magnitude of price erosion after each entry wave

How does entecavir’s market share evolve after generic entry?

Fast answer: Entecavir’s post-generic market is characterized by:

Rapid margin compression due to price cuts and PBM/formulary competition
Volume resilience driven by chronic dosing continuity and inertia
Brand retention limited by payer steering and patient switching economics

What drives entecavir brand vs generic mix

Payer preferencing (tier placement, prior auth requirements)
Clinician switching tolerance in long-term therapy
Patient-specific factors (history of resistance, renal function considerations)
Tender/contract mechanics in national or regional health systems

Expected financial shape

In mature CHB markets, cashflows typically show:

A “step down” around the first major generic conversion
Gradual further erosion as additional competitors enter and as list-to-net discounting increases
Brand stabilization only when switching costs outweigh short-term payer savings

What generic entry risks exist for entecavir in the US (ANDA/Paragraph IV)?

Fast answer: The principal US risk channel is the sequencing of ANDA filings that trigger earlier-than-expiry launches through Paragraph IV challenges. For an already mature molecule, the risk is usually less about brand IP staying alive and more about how fast multiple ANDAs convert to approved, launch-ready products.

What matters for launch readiness

ANDA approval status
Patent carve-outs or entry conditions tied to settlement agreements
Manufacturing validation and supply continuity

Why Paragraph IV still matters financially

Even when core patents are older, Paragraph IV outcomes can:

Accelerate first-in-class generic penetration
Determine whether a market gets one launch date or multiple staggered launches
Influence how fast the brand loses formulary placement

How does entecavir compare with tenofovir alafenamide and tenofovir disoproxil fumarate on competitive economics?

Fast answer: Entecavir faces long-horizon competitive pressure from tenofovir-based HBV regimens, particularly where efficacy and renal/bone profiles favor tenofovir variants. Financial trajectory depends on whether payer and prescriber preferences shift eligible cohorts away from entecavir.

Competitive displacement mechanisms

Treatment guideline migration toward preferred agents for broader populations
Renal safety and dosing convenience influencing first-line selection
Switching after virologic failure or adverse-event history

Where entecavir can still hold

Patients stable on entecavir with controlled HBV DNA and acceptable tolerability
Clinical scenarios where entecavir is selected due to prior treatment history or specific contraindications

Revenue outcome

In economic terms:

Entecavir’s revenue tends to become more “replacement demand” than “new starts” demand as newer agents capture incremental prescriptions.

What formulations are protected by entecavir patents and what barriers exist for generic tablets?

Fast answer: Formulation patents are usually a secondary barrier for well-known molecules, and generics often clear formulation-related constraints once composition and use barriers expire.

Formulation/IP claim areas that can delay entries

Tablet composition ranges and excipient systems
Dissolution specifications and test method constraints
Crystallinity or solid-state form control (if claimed)

Practical barrier assessment for generic manufacturing

Even when formulation claims exist, generics commonly mitigate through:

Equivalent dissolution and bioavailability approaches
Demonstrated manufacturing reproducibility
If permitted, design-around of claimed excipient ranges

What litigation affects entecavir commercialization and generic timelines?

Fast answer: In mature small-molecule markets, litigation tends to shift launch dates and bargaining power via settlement timing rather than permanently blocking generics.

What an entecavir litigation timeline typically governs

Court decisions that confirm or invalidate listed patents
Settlement agreements that define “carve-out” dates
Dismissals tied to non-infringement or covenant not-to-sue terms

Financial linkage

Litigation affects:

Whether brand remains cash-protected until a negotiated date
Whether generics enter simultaneously (larger price shock) or sequentially (less steep decline)

What FDA regulatory status does entecavir have and what does it mean for supply and demand?

Fast answer: Entecavir is an established FDA-approved CHB antiviral with a stable regulatory track. Its practical market effect is less about new approval and more about stable supply and the continuing clinician confidence that supports chronic therapy persistence.

How FDA status impacts revenue

Stable availability reduces switching friction and supports ongoing prescriptions
Post-approval supplement activity can affect manufacturing and labeling, but not typically demand magnitude in mature markets
Generic substitution depends on AB-rated equivalence and payer policies, not on FDA novel product approvals

How do pricing and reimbursement dynamics shape entecavir’s net revenue trajectory?

Fast answer: The entecavir financial trajectory is determined by list price erosion versus net price after rebates, discounts, and payer contracting. Mature-market PBM and national tender dynamics usually drive persistent net price compression after major generic entries.

Net price mechanics

For chronic therapy drugs in the US:

Rebates and discounts expand as competitors enter
Utilization management (prior authorization, step edits) can increase but often is rebalanced as payer needs shift
Manufacturer support programs can delay total brand-to-generic substitution but rarely prevent it long term in fully contestable classes

Global reimbursement

In EU/UK:

HTA-based positioning and class contracting often compress prices
National formularies may keep entecavir in restricted lines rather than eliminate it immediately

Which geographies still offer meaningful entecavir growth versus decline?

Fast answer: Entecavir’s growth ceiling is generally constrained to regions with delayed generic penetration or slower payer switching cycles. Declines are expected where generics are available and payer contracting is aggressive.

Geographic commercialization pattern

US: mature generic competition with ongoing net price pressure
EU/UK: slower switching can maintain stable volumes, but price pressure intensifies after competitive procurement
Middle East/Latin America/APAC: trajectory depends on local patent enforceability, generic readiness, and tender timing

What is the likely future financial trajectory for entecavir?

Fast answer: Over the near-to-mid term, entecavir’s economics are more likely to be driven by volume stability versus price erosion and competitive displacement by tenofovir-based regimens. Net revenue typically trends down unless (1) the market retains a meaningful “stable on therapy” cohort and (2) generic competition does not add new pricing shocks.

Base-case drivers

Continued payer preference shifts toward tenofovir-based therapies for new starts
Persistent demand among stable, long-term entecavir patients
Ongoing price compression from generic supply

Downside drivers

Accelerated generic entry waves in remaining competitive markets
Payer restriction tightening that forces switching
Regulatory or guideline updates that reclassify entecavir into narrower segments

Upside drivers

Slow switching behavior in specific national systems
Supply stability that maintains uninterrupted access and minimizes prescriber changes
Formulary inclusion in high-volume CHB segments despite tenofovir competition

Key market-dynamics dashboard (what to monitor next)

Factor	What to monitor	Why it moves revenue
Patent expiry and Orange Book status	Remaining listed patent expiry dates and any active enforcement	Launch timing and competitive entry sequencing
Generic competition intensity	Number of approved ANDAs and authorized/launch products	Step-change in price and net revenue
Payer contracting	PBM tier changes, rebate pressure, tender outcomes	List-to-net erosion
Guideline/prescriber selection	New-start preference for tenofovir regimens	Volume shift from initiation to maintenance
Switching friction	Prior authorization rules and clinical inertia	Preserves stable cohort volumes

Key Takeaways

Entecavir’s financial trajectory is shaped by mature generic competition and chronic-therapy inertia rather than by new primary IP leverage.
Revenue typically follows a pattern: sharp net price erosion after generic conversion, then gradual stabilization if payer switching remains controlled and stable patients remain on therapy.
Competitive displacement by tenofovir-based HBV regimens constrains new-start uptake over time, pushing entecavir toward “maintenance cohort” economics.
The highest incremental revenue risk is staged generic entry and payer contracting tightening in geographies where competitive procurement is still ramping.

FAQs

1) Does entecavir still face major patent-based barriers in the US?
Patent-based barriers for entecavir are usually mature and largely depend on any remaining Orange Book listings with later expiration dates that can delay ANDA entry timing.

2) What is the biggest driver of entecavir revenue today: price or volume?
Price, via list-to-net discounting and formulary contracting, typically dominates once generic competition is established; volume is more stable due to chronic therapy continuity.

3) How do tenofovir regimens affect entecavir’s new-start share?
Tenofovir-based regimens typically capture incremental new starts as guidelines and clinician preferences shift, leaving entecavir with a larger share of maintenance rather than initiation.

4) Can settlements with generics change entecavir financial outcomes?
Yes, settlements can accelerate or delay launch dates, altering the timing of price shocks and the pace of formulary switching.

5) Which markets are most sensitive to entecavir generic price erosion?
Markets with aggressive tendering, rapid generic adoption, and strong payer substitution mechanisms typically see the steepest net price compression.

References

No sources were provided in the prompt, and no external documents were cited.

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	20
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	253
Patent Applications:	6,492
Drug Prices:	Drug price trends for ENTECAVIR
What excipients (inactive ingredients) are in ENTECAVIR?	ENTECAVIR excipients list
DailyMed Link:	ENTECAVIR at DailyMed

Sponsor	Phase
The First Affiliated Hospital of Henan Polytechnic University	PHASE4
Sanmenxia Central Hospital	PHASE4
Yongcheng People's Hospital	PHASE4

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	ENTECAVIR	entecavir	TABLET;ORAL	206745-001	Jun 23, 2017	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Rx	ENTECAVIR	entecavir	TABLET;ORAL	206294-002	Nov 23, 2016		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Usa	ENTECAVIR	entecavir	TABLET;ORAL	202122-002	Aug 26, 2014		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sunshine	ENTECAVIR	entecavir	TABLET;ORAL	211978-001	May 20, 2020		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Conba Usa	ENTECAVIR	entecavir	TABLET;ORAL	216857-001	Dec 23, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Usa	ENTECAVIR	entecavir	TABLET;ORAL	202122-001	Aug 26, 2014		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Accord Hlthcare	ENTECAVIR	entecavir	TABLET;ORAL	205824-002	Aug 25, 2017		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Summary for ENTECAVIR

Recent Clinical Trials for ENTECAVIR

Pharmacology for ENTECAVIR

Anatomical Therapeutic Chemical (ATC) Classes for ENTECAVIR

Paragraph IV (Patent) Challenges for ENTECAVIR