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

Last Updated: March 29, 2024

ENVARSUS XR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-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-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 10th, 2009.

  Try a Trial

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 Health Network, TorontoPhase 4
University of AlbertaPhase 4
University of British ColumbiaPhase 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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

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

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

Stabilized tacrolimus composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

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

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

Tacrolimus for improved treatment of transplant patients
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

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

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

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Stabilized tacrolimus composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release compositions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid dispersions comprising tacrolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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.