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Last Updated: June 27, 2022

ENVARSUS XR Drug Patent Profile


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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 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 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.

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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-six US patents and one FDA Regulatory Exclusivity.

Patents protecting ENVARSUS XR

Stabilized tacrolimus composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid dispersions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Solid dispersions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Solid dispersions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid dispersions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Tacrolimus for improved treatment of transplant patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF ORGAN REJECTION

Stabilized tacrolimus composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release compositions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid dispersions comprising tacrolimus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ENVARSUS XR

PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY TRANSPLANT PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 B.V. 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
>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
Canada 2688381 FORME PHARMACEUTIQUE ORALE A ADMINISTRER UNE FOIS PAR JOUR COMPORTANT DU TACROLIMUS (ONCE DAILY ORAL DOSAGE FORM COMPRISING TACROLIMUS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005020993 See Plans and Pricing
Denmark 2101419 See Plans and Pricing
Portugal 2360849 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Merck

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