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Tacrolimus - Generic Drug Details

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

This ingredient has ninety-five patent family members in thirty-three countries.

There are eighteen drug master file entries for tacrolimus. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: tacrolimus

Tradenames:5
Patents:16
Applicants:10
NDAs:13
Drug Master File Entries: see list18
Suppliers / Packaging: see list25
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tacrolimus

Clinical Trials for: tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
TACROLIMUS
tacrolimus
CAPSULE;ORAL091195-002Aug 31, 2011RXNo<disabled><disabled>
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-002Jul 10, 2015RXNo8,486,993<disabled>Y <disabled>
Strides Pharma
TACROLIMUS
tacrolimus
CAPSULE;ORAL090687-002Jul 22, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: tacrolimus

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

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,014,038,998<disabled in preview>
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International Patent Family for Ingredient: tacrolimus

Country Document Number Estimated Expiration
Portugal1421939<disabled in preview>
BrazilPI0414000<disabled in preview>
TaiwanI510238<disabled in preview>
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