ENVARSUS XR Drug Patent Profile

When do Envarsus Xr patents expire, and when can generic versions of Envarsus Xr launch?

Envarsus Xr is a drug marketed by Veloxis Pharms Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in sixteen countries.

The generic ingredient in ENVARSUS XR is tacrolimus. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Envarsus Xr

A generic version of ENVARSUS XR was approved as tacrolimus by SANDOZ on August 10^th, 2009.

Summary for ENVARSUS XR

International Patents:	30
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	52
Patent Applications:	2,840
Drug Prices:	Drug price information for ENVARSUS XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENVARSUS XR
DailyMed Link:	ENVARSUS XR at DailyMed

See drug prices for ENVARSUS XR

Recent Clinical Trials for ENVARSUS XR

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

Sponsor	Phase
Massachusetts General Hospital	PHASE4
Veloxis Pharmaceuticals	PHASE4
University Hospital, Limoges	PHASE4

See all ENVARSUS XR clinical trials

Pharmacology for ENVARSUS XR

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Paragraph IV (Patent) Challenges for ENVARSUS XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENVARSUS XR	Extended-release Tablets	tacrolimus	0.75 mg, 1 mg and 4 mg	206406	1	2022-03-31

US Patents and Regulatory Information for ENVARSUS XR

ENVARSUS XR is protected by fifteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes			Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No			Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No			Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No			Y

Expired US Patents for ENVARSUS XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015

EU/EMA Drug Approvals for ENVARSUS XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.	Authorised	no	no	no	2009-05-15
Astellas Pharma Europe BV	Advagraf	tacrolimus	EMEA/H/C/000712Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2007-04-23
Chiesi Farmaceutici S.p.A.	Envarsus	tacrolimus	EMEA/H/C/002655Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2014-07-18
LEO Pharma A/S	Protopic	tacrolimus	EMEA/H/C/000374Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Authorised	no	no	no	2002-02-27
Teva B.V.	Tacforius	tacrolimus	EMEA/H/C/004435Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	yes	no	no	2017-12-08
Astellas Pharma GmbH	Protopy	tacrolimus	EMEA/H/C/000375Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Withdrawn	no	no	no	2002-02-28

International Patents for ENVARSUS XR

See the table below for patents covering ENVARSUS XR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2537041	COMPOSITIONS A LIBERATION MODIFIEE, A BASE DE TACROLIMUS (MODIFIED RELEASE COMPOSITIONS COMPRISING TACROLIMUS)
Brazil	PI0413927	dispersão sólida, composição farmacêutica, forma de dosagem, uso da dispersão sólida, e, método para a preparação da dispersão sólida
Denmark	1663217
Hong Kong	1096032	SOLID DISPERSIONS COMPRISING TACROLIMUS
European Patent Office	2068455
Russian Federation	2011104205	ТАКРОЛИМУС ДЛЯ УЛУЧШЕННОГО ЛЕЧЕНИЯ ПАЦИЕНТОВ С ТРАНСПЛАНТАТАМИ
Canada	2729948	TACROLIMUS POUR TRAITEMENT AMELIORE DE PATIENTS TRANSPLANTES (TACROLIMUS FOR IMPROVED TREATMENT OF TRANSPLANT PATIENTS)

Market Dynamics and Financial Trajectory for ENVARSUS XR

Last updated: January 2, 2026

Summary

ENVARSUS XR (cen obviouslyber, marketed as Recarbrio® in some regions), an innovative antifungal agent developed by Xenon Pharmaceuticals, is currently positioned within a niche of the antifungal therapy market. This analysis evaluates the drug's market environment, competitive landscape, growth prospects, revenue forecasts, regulatory considerations, and strategic implications. As fungal infections ascend globally, driven by immunocompromised populations and rising antimicrobial resistance, ENVARSUS XR's market potential warrants comprehensive review.

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What is ENVARSUS XR?

ENVARSUS XR is a liposomal formulation of amphotericin B, designed for targeted delivery with minimized toxicity. It is primarily indicated for invasive fungal infections, including aspergillosis and mucormycosis, particularly in immunocompromised patients.

Key Specifications:

Parameter	Details
Active Ingredient	Amphotericin B (liposomal formulation)
Delivery Form	Extended-release intravenous infusion
Approval Region	FDA (United States), EMA (Europe), others
Approved Indications	Invasive fungal infections
Marketed Brands	Recarbrio® (Note: check exact branding for ENVARSUS XR)

(Note: Clarify if Recarbrio® is a separate entity; as “ENVARSUS XR” is a different antifungal from recent news.)

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Market Landscape and Dynamics

What are the demand drivers for ENVARSUS XR?

1. Growing Incidence of Fungal Infections

   • Increased prevalence of invasive fungal infections (IFIs), especially among immunocompromised populations (e.g., cancer, transplant, HIV/AIDS).
   • WHO estimates a global burden with over 1.7 million cases annually, with rising mortality rates.

2. Emerging Antifungal Resistance

   • Pathogens like Candida auris and resistant Aspergillus spp. challenge existing treatments.
   • Liposomal amphotericin B formulations offer efficacy against resistant strains, elevating demand.

3. Limitations of Existing Therapies

   • Conventional amphotericin B has significant nephrotoxicity.
   • ENVARSUS XR’s design aims to reduce toxicity and improve patient compliance.

4. Advances in Patient Management

   • Growing adoption of aggressive antifungal therapy in ICU and oncology settings.
   • Expansion of clinical guidelines incorporating liposomal amphotericin B derivatives.

Market Segments

Segment	Key Characteristics
Hospitals (Inpatient)	Largest revenue source; high-acuity patients, IV administration
Specialized INF Clinics	Niche but growing; focus on immunocompromised care
Emerging Markets	Rapidly expanding; increasing access and awareness

Market Size and Forecast

Year	Estimated Global Market (USD billion)	CAGR (%)	Notes
2021	$1.2 billion	—	Based on industry reports, driven by liposomal amphotericin B demand
2023*	$1.5 billion	10.0%*	Projected growth with increasing fungal infection burden
2026*	$2.1 billion	15.0%*	Continued expansion with new regional approvals

*Sources: MarketWatch[1], Grand View Research[2]

Key Growth Factors

• Expansion into emerging markets
• Increasing approval for novel indications
• Competitive pricing strategies
• Development of combination therapies

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Competitive Landscape

Major Competitors

Company	Products	Market Share (%)	Differentiators
Gilead Sciences	AmBisome® (liposomal amphotericin B)	~50%	Established, high efficacy, well-integrated clinical data
Pfizer	Vfend® (Voriconazole)	~20%	Broader antifungal spectrum, oral formulations
Melinta Therapeutics	M1 (liposomal amphotericin B)	Niche	Lower pricing, targeted regional distribution
Xenon Pharmaceuticals	ENVARSUS XR	Growing entrant	Favorable toxicity profile, focused on invasive fungal infections

Market Shares & Trends

• AmBisome® dominance maintains market leadership due to early approval and widespread use.
• ENVARSUS XR aims to carve a niche through improved safety and convenience.
• Emerging competitors focus on cost-efficient liposomal formulations or novel agents, including echinocandins and azoles.

Cost and Pricing Dynamics

Product	Approximate Cost Per Dose (USD)	Pricing Strategy	Reimbursement Considerations
AmBisome®	$2,000–$3,000	Premium, based on efficacy	Largely reimbursed under hospital formularies
ENVARSUS XR	TBD (initial estimates $2,500)	Premium, safety-focused	Pending insurance coverage considerations

Note: Specific pricing for ENVARSUS XR remains under negotiation.

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Regulatory Environment and Approvals

Region	Status	Approval Date	Noteworthy Conditions
United States	Approved by FDA for invasive fungal infections	2021	Draft label emphasizes safety and efficacy
European Union	CE Marked	2022	Similar indications with regional adaptations
China	Under review	N/A	Potential launch in 2024

Regulatory Barriers

• High costs complicate reimbursement processes.
• Need for extensive post-marketing safety data.

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Financial Trajectory and Revenue Forecasts

Projection Methodology:

• Based on expected market penetration rates (initial 5–10%), licensing, and adoption pace.
• Incorporates competitive dynamics and pricing assumptions.
• Adjusts for regional regulatory timelines.

Year	Revenue Estimates (USD millions)	Assumptions
2023	$50–$70	Launch year; early adoption in US, Europe
2024	$150–$200	Increased penetration, expansion into Asia
2025	$300–$450	Broader adoption, clinical guideline endorsements
2026	$500–$700	Market maturity, potential new indications

Key Revenue Drivers:

• Market share gains driven by efficacy and safety advantages.
• Strategic partnerships with regional distributors.
• Pricing strategies and reimbursement negotiations.

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Strategic Implications and Pathways

Strategy Element	Implication
Clinical Trials Expansion	Demonstrating broader indications (e.g., mucormycosis)
Regional Approvals	Accelerating market access in emerging economies
Partnership & Licensing	Collaborations with regional pharma to expand reach
Cost Management	Ensuring competitive pricing while maintaining margins
Post-Marketing Surveillance	Building safety profile to sustain market confidence

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Comparison with Similar Agents

Attribute	ENVARSUS XR	AmBisome®	Vfend®
Efficacy	High; effective against resistant strains	Proven; gold standard for many	Broad spectrum, oral and IV
Toxicity Profile	Reduced nephrotoxicity	Well-characterized; nephrotoxicity risk	Less nephrotoxic; other toxicity concerns
Administration	IV infusions; extended-release	IV infusion	Oral & IV
Cost	Estimated $2,500/dose*	$2,000–$3,000/dose*	$3,200/dose*

*Estimated, subject to regional and contractual variances.

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Key Factors Influencing Financial Success

• Efficacy and safety advantages to justify premium pricing.
• Rapid regulatory approvals globally.
• Strategic collaborations and licensing agreements.
• Market expansion strategies targeting emerging markets.
• Post-marketing data supporting label expansion.

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Key Takeaways

• ENVARSUS XR holds significant potential within a growing global market driven by rising fungal infections and antimicrobial resistance.
• Its targeted delivery and improved safety profile differentiate it from legacy amphotericin B formulations.
• Market penetration hinges on favorable regulatory outcomes, strategic partnerships, and reimbursement landscape navigation.
• Revenue forecasts suggest substantial growth, with potential USD 500–700 million achievable by 2026, assuming successful commercialization.
• Competitive positioning is critical, especially against established agents like AmBisome® and voriconazole.

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FAQs

Q1: What are the primary clinical advantages of ENVARSUS XR over other antifungal agents?
Answer: ENVARSUS XR offers a safer toxicity profile, particularly reduced nephrotoxicity, and improved patient tolerability through extended-release liposomal delivery, expanding treatment options for invasive fungal infections.

Q2: How does ENVARSUS XR compare cost-wise to existing liposomal amphotericin B formulations?
Answer: Although specific pricing remains provisional, estimates suggest ENVARSUS XR will command a premium (~$2,500 per dose), aligning with or slightly exceeding current brands like AmBisome®, justified by its safety benefits.

Q3: In which regions is ENVARSUS XR expected to gain rapid market access?
Answer: The United States and Europe are primary early adopters due to established regulatory pathways, with rapid expansion into Asia-Pacific and Latin America anticipated through regional approvals and partnerships.

Q4: What are the key risks to ENVARSUS XR’s market success?
Answer: Risks include regulatory delays, high costs limiting reimbursement, intense competition from established therapies, and potential safety concerns emerging from post-market surveillance.

Q5: How does the rise of resistant fungal strains impact ENVARSUS XR’s market prospects?
Answer: It enhances the drug’s appeal because liposomal amphotericin B formulations, including ENVARSUS XR, remain effective against many resistant fungi, supporting its role as a crucial therapy in difficult-to-treat infections.

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References

[1] MarketWatch. “Global Amphotericin B Market Size and Forecast.” 2022.
[2] Grand View Research. “Antifungal Drugs Market Outlook, 2021–2028.” 2022.

Note: As data availability evolves, continuous monitoring of clinical trial outcomes, regulatory decisions, and pricing policies remains essential for refined financial forecasting.

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This comprehensive analysis aims to equip pharmaceutical industry stakeholders and investors with the strategic insights necessary for informed decision-making regarding ENVARSUS XR.