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Details for Generic Name: tacrolimus

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

This ingredient has one hundred and twenty patent family members in thirty-nine countries.

There are eighteen drug master file entries for tacrolimus. Eight suppliers are listed for this compound.

Summary for Generic Name: tacrolimus

Tradenames:5
Patents:17
Applicants:10
NDAs:13
Drug Master File Entries: see list18
Suppliers / Packaging: see list41
Therapeutic Class:Dermatological Agents

Pharmacology for Ingredient: tacrolimus

Clinical Trials for: tacrolimus

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
ASTAGRAF XL
tacrolimus
CAPSULE, EXTENDED RELEASE;ORAL204096-003Jul 19, 2013RXYes6,440,458<disabled>Y <disabled>
Accord Hlthcare
TACROLIMUS
tacrolimus
CAPSULE;ORAL091195-001Aug 31, 2011RXNo<disabled><disabled>
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYes8,591,946<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: tacrolimus

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 19945,260,301<disabled>
Astellas
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 20005,665,727<disabled>
Astellas
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-001Dec 8, 20005,385,907<disabled>
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International Patent Family for Ingredient: tacrolimus

Country Document Number Publication Date
Austria531368Nov 15, 2011
World Intellectual Property Organization (WIPO)2011100975Aug 25, 2011
Yugoslavia58000Aug 29, 2003
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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