ENVARSUS XR Drug Patent Profile

Which patents cover Envarsus Xr, and what generic alternatives are available?

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-four 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:	4,298
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
Veloxis Pharmaceuticals	PHASE4
Massachusetts General Hospital	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	8,664,239
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	10,166,190		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	9,549,918		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	12,403,095		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No	8,664,239

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	8,617,599
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015	8,889,186
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015	8,889,185
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015	8,889,186
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015	9,763,920

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

International Patents for ENVARSUS XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	6044034
Denmark	1663216
Croatia	P20110288
Taiwan	201143770	Stabilized tacrolimus composition
Russian Federation	2574006	ТАКРОЛИМУС ДЛЯ УЛУЧШЕННОГО ЛЕЧЕНИЯ ПАЦИЕНТОВ С ТРАНСПЛАНТАТАМИ (TACROLIMUS FOR IMPROVED TREATMENT OF PATIENTS WITH GRAFTS)

Market Dynamics and Financial Trajectory for ENVARSUS XR

Last updated: July 27, 2025

Introduction

ENVARSUS XR (remlarsen), a high-potential pharmaceutical product, is a long-acting, orally-disintegrating calcineurin inhibitor approved for the prevention of organ rejection in kidney transplant recipients. Developed and marketed by fascia-led pharmaceutical companies, ENVARSUS XR occupies a critical niche in transplant immunosuppressant therapy. Its unique pharmacokinetic profile—offering once-daily administration—positions it favorably within the competitive landscape. Understanding the market dynamics and the financial trajectory of ENVARSUS XR is essential for stakeholders, including investors, healthcare providers, and industry analysts, to gauge the drug’s growth potential and strategic positioning.

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Market Landscape and Drivers

Prevalence of Organ Transplantation and Immunosuppressants

The global kidney transplant market is expanding steadily, driven by rising prevalence of end-stage renal disease (ESRD), aging populations, and improved transplant rates. According to the Global Data report (2022), approximately 89,000 kidney transplants occurred worldwide in 2021, with an annual growth rate of 4.5% [1]. The immunosuppressant segment, including drugs like tacrolimus, cyclosporine, and newer agents such as ENVARSUS XR, is pivotal in post-transplant care.

Shift Toward Long-Acting and Oral Therapies

There is a pronounced shift towards long-acting and orally administered immunosuppressants to enhance patient compliance and reduce hospitalization costs. ENVARSUS XR’s once-daily dosing offers superior convenience compared to twice-daily formulations, fostering better adherence and potentially improving long-term transplant outcomes.

Competitive Landscape

ENVARSUS XR faces competition primarily from branded tacrolimus formulations (e.g., Advagraf, Astagraf), as well as from generics. However, its distinct features—such as reduced variability in drug levels and improved safety profile—offer a competitive advantage. Additionally, the increasing focus on personalized medicine and therapeutic drug monitoring favors drugs with predictable pharmacokinetics like ENVARSUS XR.

Regulatory and Reimbursement Environment

Regulatory approvals in key markets such as the US, EU, and Japan have established ENVARSUS XR as a treatment option. Reimbursement policies favor therapies that demonstrate superior adherence and reduced adverse events, supporting its market penetration. However, reimbursement hurdles and pricing pressures are ongoing concerns that may influence sales growth.

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Financial Trajectory and Revenue Forecasts

Initial Launch and Early Growth

Since its initial approval in 2017, ENVARSUS XR's financial trajectory has been characterized by cautious but steady growth, driven by adoption in transplant centers and evolving clinical guidelines. Early sales figures reflected the typical ramp-up phase, with initial revenues primarily sourced from North America, where transplant volumes are higher and healthcare infrastructure supports adoption.

Sales Growth Drivers

• Expanding Indications: Currently approved for kidney transplantation, future approvals for liver or heart transplantation could significantly enhance revenue streams.
• Geographical Expansion: Market penetration in Europe, Asia-Pacific, and emerging economies is expected to accelerate as regulatory approvals are secured.
• Patient Adherence Benefits: Empirical data indicating improved adherence and reduced rejection episodes can lead to higher formulary acceptance and prescribing rates.

Projected Revenue Trends

Industry analyst consensus anticipates that ENVARSUS XR could reach cumulative revenues of approximately $500 million globally by 2025, up from an estimated $150 million in 2022. This growth is predicated on continued adoption, new indications, and increased global market share.

Profit Margins and Cost Dynamics

As a branded drug, ENVARSUS XR benefits from high-margin pricing, though price erosion from generic competition remains a risk. Manufacturing costs have decreased with scale, improving profitability margins over time. Strategic investment in marketing and clinical research is expected to support sustained growth.

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Market Challenges and Risks

Generic Competition and Price Erosion

The expiration of patents or entry of generic versions can substantially reduce revenues. For ENVARSUS XR, patent lifecycle management and potential litigation are critical factors in maintaining market exclusivity.

Market Penetration Barriers

Physician familiarity with established tacrolimus products and existing clinician prescribing habits pose barriers to rapid market adoption. Education campaigns and clinical evidence are instrumental in facilitating switch and initiation protocols.

Clinical and Regulatory Risks

Emergent data regarding safety profiles or efficacy issues could impact prescribing patterns. Likewise, regulatory delays in new indications or approvals in key regions could hinder revenue growth.

Reimbursement Constraints

Price controls and stringent reimbursement policies in certain countries may limit profit margins and slow market expansion.

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Strategic Opportunities for Growth

• New Indications: Expanding into liver and heart transplantation markets can diversify revenue streams.
• Combination Therapies: Developing fixed-dose combinations with other immunosuppressants to improve compliance.
• Biomarker Development: Leveraging advancements in pharmacogenomics to personalize immunosuppressant therapy enhances clinical outcomes and market appeal.
• Global Expansion: Strategic partnerships in emerging markets for distribution and local clinical trials.

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Conclusion

ENVARSUS XR’s market dynamics are shaped by shifts towards long-acting immunosuppressants, a favorable regulatory environment, and the imperative for improved patient compliance. While initial revenue trajectories indicate promising growth, the competitive landscape and patent protections significantly influence its financial outlook. Sustainable growth hinges on effective market positioning, new indication approvals, and strategic geographic expansion—factors poised to dictate its long-term financial trajectory.

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Key Takeaways

• Growing Transplant Market: Increasing global transplant rates underpin demand for effective immunosuppressants like ENVARSUS XR.
• Competitive Edge: Its once-daily dosing and favorable pharmacokinetics favor adoption over traditional tacrolimus formulations.
• Revenue Growth Potential: Industry projections estimate revenues could exceed $500 million globally by 2025, contingent on successful market expansion and regulatory approvals.
• Risks: Patent expiry, generic competition, and reimbursement constraints pose significant challenges.
• Strategic Focus: Expanding indications, geographic footprint, and leveraging clinical data for adherence and safety advantages are essential strategies.

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FAQs

1. What distinguishes ENVARSUS XR from other tacrolimus formulations?
ENVARSUS XR features a prolonged-release, once-daily oral formulation that provides more stable drug levels, potentially improving adherence and reducing toxicity risks compared to twice-daily tacrolimus products.

2. How does patent protection influence ENVARSUS XR’s market exclusivity?
Patent protections safeguard ENVARSUS XR from generic competition for several years post-approval. Patent expiration could lead to price erosion and increased competition from generics, impacting revenues.

3. What is the potential for ENVARSUS XR to expand into other transplant markets?
While currently approved for kidney transplantation, regulatory approval for liver and heart transplants could significantly expand its market, given the similar immunosuppressive needs.

4. Which regions present the most growth opportunities for ENVARSUS XR?
Europe and Asia-Pacific are key growth regions, owing to increasing transplant volumes and favorable regulatory environments. Emerging markets in these regions are particularly promising.

5. What role does personalized medicine play in the future of ENVARSUS XR?
Advancements in pharmacogenomics can optimize dosing, minimize adverse effects, and improve outcomes, making ENVARSUS XR a candidate for personalized immunosuppressive regimens, thus bolstering its market appeal.

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Sources
[1] Global Data, “Transplant Market Analysis,” 2022.