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Last Updated: March 19, 2024

TACROLIMUS Drug Patent Profile


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Which patents cover Tacrolimus, and what generic alternatives are available?

Tacrolimus is a drug marketed by Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Encube, and Fougera Pharms Inc. and is included in nineteen NDAs.

The generic ingredient in TACROLIMUS 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 Tacrolimus

A generic version of TACROLIMUS was approved as tacrolimus by SANDOZ on August 10th, 2009.

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Drug patent expirations by year for TACROLIMUS
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Recent Clinical Trials for TACROLIMUS

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SponsorPhase
Zhishui ChenPhase 4
Heinrich-Heine University, DuesseldorfPhase 1/Phase 2
Koordinierungszentrum für Klinische Studien - DuesseldorfPhase 1/Phase 2

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Pharmacology for TACROLIMUS
Medical Subject Heading (MeSH) Categories for TACROLIMUS
Paragraph IV (Patent) Challenges for TACROLIMUS
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
ASTAGRAF XL Extended-release Capsules tacrolimus 0.5 mg, 1 mg, and 5 mg 204096 1 2013-09-24
PROTOPIC Ointment tacrolimus 0.03% 050777 1 2010-11-22
PROTOPIC Ointment tacrolimus 0.10% 050777 1 2010-09-09

US Patents and Regulatory Information for TACROLIMUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira TACROLIMUS tacrolimus INJECTABLE;INJECTION 203900-001 Aug 25, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Panacea TACROLIMUS tacrolimus CAPSULE;ORAL 090802-001 Sep 28, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms Inc TACROLIMUS tacrolimus OINTMENT;TOPICAL 200744-001 Sep 9, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharma Avet TACROLIMUS tacrolimus CAPSULE;ORAL 090402-001 Jul 1, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Panacea TACROLIMUS tacrolimus CAPSULE;ORAL 090802-002 Sep 28, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan TACROLIMUS tacrolimus CAPSULE;ORAL 090596-001 Sep 17, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 TACROLIMUS

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

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