You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

ENVARSUS XR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Envarsus Xr patents expire, 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-two 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 10th, 2009.

  Sign Up

Drug patent expirations by year for ENVARSUS XR
Drug Prices for ENVARSUS XR

See drug prices for ENVARSUS XR

Recent Clinical Trials for ENVARSUS XR

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

SponsorPhase
University Hospital, EssenPhase 3
University Health Network, TorontoPhase 4
University of AlbertaPhase 4

See all ENVARSUS XR clinical trials

Pharmacology for ENVARSUS XR
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-eight US patents.

Patents protecting ENVARSUS XR

Stabilized tacrolimus composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Stabilized tacrolimus composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Stabilized tacrolimus composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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
Astellas Pharma GmbH Protopy tacrolimus EMEA/H/C/000375
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. 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ENVARSUS XR

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

Country Patent Number Title Estimated Expiration
Japan 2010506443 ⤷  Sign Up
European Patent Office 2360849 Procédé et dispositif de distribution et traitement de séquences dans un système de communication (Method and apparatus for sequence distribution and processing in a communication system) ⤷  Sign Up
Denmark 2575769 ⤷  Sign Up
Norway 334986 ⤷  Sign Up
Russian Federation 2574006 ТАКРОЛИМУС ДЛЯ УЛУЧШЕННОГО ЛЕЧЕНИЯ ПАЦИЕНТОВ С ТРАНСПЛАНТАТАМИ (TACROLIMUS FOR IMPROVED TREATMENT OF PATIENTS WITH GRAFTS) ⤷  Sign Up
Austria E498249 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.