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 twenty-three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-six patent family members in twenty-four countries.

The generic ingredient in ENVARSUS XR is tacrolimus. There are twenty drug master file entries for this compound. Thirty-five 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:	66
US Patents:	23
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	49
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
University Hospital, Essen	Phase 3
University Health Network, Toronto	Phase 4
University of Alberta	Phase 4

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 twenty-nine 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	10,548,880
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	8,889,185
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	9,763,920		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	11,419,823		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	8,586,084

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	8,586,084
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015	9,161,907
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	206406-003	Jul 10, 2015	8,623,410
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015	8,889,186

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/000954 Prophylaxis 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/000712 Prophylaxis 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/002655 Prophylaxis 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/000374 Flare 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/004435 Prophylaxis 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
Eurasian Patent Organization	027869	СТАБИЛИЗИРОВАННАЯ КОМПОЗИЦИЯ ТАКРОЛИМУСА (STABILIZED TACROLIMUS COMPOSITION)
Japan	2015035830	通信システムにおける系列分配及び処理のための方法及び装置 (METHOD AND DEVICE FOR DISTRIBUTING AND PROCESSING SERIES IN COMMUNICATION SYSTEM)
Portugal	2068455
China	101869561	Tacrolimus-containing improved release composition
Austria	473003

ENVARSUS XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Envarsus XR

Introduction

Envarsus XR, an extended-release formulation of the immunosuppressant tacrolimus, has been a significant player in the market for kidney transplant patients. Developed by Veloxis Pharmaceuticals, which was later acquired by Asahi Kasei, the drug has shown promising growth and unique market dynamics.

Market Size and Share

The market for immunosuppressants in the US is substantial, with an estimated size of approximately $1.5 billion in 2018. Envarsus XR has carved out a notable share in this market, particularly in the new kidney transplants submarket, where its market share is around 20% and is expected to grow to 30%[4].

Competitive Advantages

Envarsus XR utilizes proprietary extended-release technology, which allows for once-daily administration and reduces side effects by suppressing the rise in maximum blood concentration after administration. This technology has been a key factor in its adoption, with over 30% of targeted transplant centers designating Envarsus XR as an essential drug after transplant[4].

Sales Performance

Historical Growth

In the first half of 2019, Envarsus XR saw a significant increase in product revenue, up 94% compared to the same period in 2018, with US revenue increasing by 96% to $28.7 million and EU revenue increasing by 76% to $4.4 million[2].

Recent Trends

In FY 2022, sales of Envarsus XR grew by about 30% year-on-year, aligning with expectations. This growth continued into FY 2023, with Q1 sales growing more than expected, up 32% year-on-year. However, Q2 sales are expected to fall slightly from Q1 levels[5].

Geographical Performance

US Market

The US has been a strong market for Envarsus XR, with more than 95% of US transplant centers utilizing the drug since its launch. Sales in the US have consistently shown strong growth, with prescriptions for new kidney transplant patients increasing beyond initial expectations[2][5].

European Market

In Europe, Envarsus XR has been licensed out and has seen significant growth, although at a slightly lower rate compared to the US market. The drug's performance in Europe is part of Veloxis's broader strategy to expand its business beyond the US[4].

Financial Outlook

Revenue Projections

For FY 2019, Veloxis revised its revenue outlook to be in the range of $69-77 million, with operating income before accounting for stock compensation expected to be between $10-15 million. By FY 2028, peak sales of Envarsus XR are estimated to reach $700-800 million[2][4].

Current Financials

In FY 2022, the operating income from the Health Care segment, which includes Envarsus XR, declined due to various factors such as the impact of the COVID-19 pandemic and higher feedstock and fuel prices. However, the segment is expected to see steady growth in FY 2023, despite some challenges[1].

Challenges and Opportunities

Market and Economic Factors

The sales of Envarsus XR have been affected by temporary factors such as the surge in demand for ventilators during the COVID-19 pandemic and economic conditions in the US. However, these factors have largely subsided, and the drug is back on its growth trajectory[3][5].

Cost and Pricing Pressures

Higher feedstock and fuel prices have put pressure on the profitability of the Health Care business category, including Envarsus XR. Despite these challenges, Asahi Kasei is working to raise prices and manage costs effectively[1].

Expansion and Growth Strategies

Market Expansion

Veloxis and Asahi Kasei are considering expanding the business to areas beyond the US and Europe. The company aims to increase its market share by expanding the designation of Envarsus XR as an essential drug in more transplant centers[4].

Product Portfolio

The acquisition of Bionova, a contract development and manufacturing organization (CDMO), and other strategic moves are expected to contribute to increased income and growth in the Medical segment, which includes Envarsus XR[1].

Key Takeaways

• Market Share: Envarsus XR has a significant market share in the new kidney transplants submarket, expected to grow to 30%.
• Sales Growth: The drug has shown strong sales growth, particularly in the US, with a 30% year-on-year increase in FY 2022.
• Financial Outlook: Peak sales are estimated to reach $700-800 million by FY 2028.
• Challenges: Higher feedstock and fuel prices, and economic conditions, have impacted profitability but are being managed.
• Expansion: The company is considering expanding its business beyond the US and Europe.

FAQs

Q: What is the current market share of Envarsus XR in the US? A: Envarsus XR has a market share slightly above 5% in the overall immunosuppressant market but around 20% in the new kidney transplants submarket[4].

Q: How has the COVID-19 pandemic affected Envarsus XR sales? A: The pandemic had a temporary impact on sales due to the surge in demand for ventilators and other factors, but these effects have largely subsided[3].

Q: What are the competitive advantages of Envarsus XR? A: Envarsus XR uses proprietary extended-release technology, allowing for once-daily administration and reducing side effects[4].

Q: What are the peak sales projections for Envarsus XR? A: Peak sales are estimated to reach $700-800 million by FY 2028[4].

Q: How is Asahi Kasei managing the impact of higher feedstock and fuel prices on Envarsus XR? A: The company is working to raise prices and manage costs effectively to mitigate these impacts[1].

Cited Sources

1. Asahi Kasei Corporation - Summary of Financial Results Briefing for Fiscal 2022
2. GlobeNewswire - Veloxis Pharmaceuticals Announces Financial Results for the First Six Months of 2019
3. Asahi Kasei Corporation - Transcript of Financial Results Conference for Q1 Fiscal 2021
4. Asahi Kasei Corporation - Briefing on “Asahi Kasei to Acquire Veloxis Pharmaceuticals Inc.”
5. Asahi Kasei Corporation - Summary of Financial Results Briefing for Q1 Fiscal 2023