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Last Updated: January 27, 2023

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, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Leo Pharma As, Fougera Pharms Inc, and Veloxis Pharms Inc, and is included in twenty-two 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-one 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

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SponsorPhase
Ossium Health, Inc.Phase 1/Phase 2
Center for International Blood and Marrow Transplant ResearchPhase 1/Phase 2
Fen LiPhase 4

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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
Dr Reddys Labs Ltd TACROLIMUS tacrolimus CAPSULE;ORAL 090509-003 May 12, 2010 AB RX No No See Plans and Pricing See Plans and Pricing 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
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No See Plans and Pricing See Plans and Pricing 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

Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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