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Last Updated: March 29, 2024

Tacrolimus - Generic Drug Details


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What are the generic drug sources for tacrolimus and what is the scope of patent protection?

Tacrolimus is the generic ingredient in five branded drugs marketed by Astellas, 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, Leo Pharma As, Encube, Fougera Pharms Inc, and Veloxis Pharms Inc, and is included in twenty-five NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty drug master file entries for tacrolimus. Thirty-six suppliers are listed for this compound.

Drug Prices for tacrolimus

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Drug Sales Revenue Trends for tacrolimus

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Recent Clinical Trials for tacrolimus

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

SponsorPhase
Zhishui ChenPhase 4
Vanderbilt University Medical CenterPhase 1
Heinrich-Heine University, DuesseldorfPhase 1/Phase 2

See all tacrolimus clinical trials

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
Accord Hlthcare TACROLIMUS tacrolimus CAPSULE;ORAL 091195-002 Aug 31, 2011 BX RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd TACROLIMUS tacrolimus CAPSULE;ORAL 206662-003 Nov 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Belcher TACROLIMUS tacrolimus CAPSULE;ORAL 206651-001 Nov 30, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 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 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Concord Biotech Ltd TACROLIMUS tacrolimus CAPSULE;ORAL 213112-003 Nov 10, 2020 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

Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 ⤷  Try a Trial ⤷  Try a Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 ⤷  Try a Trial ⤷  Try a Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 ⤷  Try a Trial ⤷  Try a Trial
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 ⤷  Try a Trial ⤷  Try a Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for tacrolimus

Country Patent Number Title Estimated Expiration
Spain 2591352 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008145143 ⤷  Try a Trial
South Korea 20110033262 TACROLIMUS FOR IMPROVED TREATMENT OF TRANSPLANT PATIENTS ⤷  Try a Trial
Russian Federation 2011104205 ТАКРОЛИМУС ДЛЯ УЛУЧШЕННОГО ЛЕЧЕНИЯ ПАЦИЕНТОВ С ТРАНСПЛАНТАТАМИ ⤷  Try a Trial
Canada 2537041 COMPOSITIONS A LIBERATION MODIFIEE, A BASE DE TACROLIMUS (MODIFIED RELEASE COMPOSITIONS COMPRISING TACROLIMUS) ⤷  Try a Trial
Australia 2004267909 Modified release compositions comprising tacrolimus ⤷  Try a Trial
Norway 20061430 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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