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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, Leo Pharma As, 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-six suppliers are listed for this compound.

Summary for Generic Name: tacrolimus

Tradenames:5
Patents:16
Applicants:11
NDAs:13
Drug Master File Entries: see list18
Suppliers / Packaging: see list26
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
Dr Reddys Labs Ltd
TACROLIMUS
tacrolimus
CAPSULE;ORAL090509-001May 12, 2010RXNo<disabled><disabled>
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXNo7,994,214<disabled>Y <disabled>
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 2000RXYes<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
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 20005,385,907<disabled>
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 19945,260,301<disabled>
Leo Pharma As
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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tacrolimus

Country Document Number Estimated Expiration
Japan4622382<disabled in preview>
Norway330578<disabled in preview>
Slovakia286887<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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