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Details for Generic Name: tacrolimus

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Tacrolimus is the generic ingredient in two branded drugs marketed by Astellas, Accord Hlthcare, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, and Fougera Pharms Inc, and is included in three NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for tacrolimus. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: tacrolimus

Drug Master File Entries: see list17
Suppliers: see list7
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tacrolimus

Tentative approvals for TACROLIMUS

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL0.75MG

Clinical Trials for: tacrolimus

Pharmacokinetic Studies of Tacrolimus in Transplant Patients
Status: Completed Condition: Kidney Transplant Recipients; Liver Transplant Recipients

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
Status: Completed Condition: Liver Transplantation

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
Status: Recruiting Condition: Renal Transplantation

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Status: Completed Condition: Liver Transplantation

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Status: Completed Condition: Liver Transplantation

A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
Status: Recruiting Condition: Liver Transplantation

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
OINTMENT; TOPICAL050777-001Dec 8, 2000RXNo<disabled><disabled>
CAPSULE; ORAL050708-002Apr 8, 1994RXYes<disabled><disabled>
CAPSULE; ORAL050708-003Aug 24, 1998RXNo<disabled><disabled>
INJECTABLE; INJECTION050709-001Apr 8, 1994RXYes<disabled><disabled>
OINTMENT; TOPICAL050777-002Dec 8, 2000RXYes<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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