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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-six patent family members in thirty-three countries.

There are eighteen drug master file entries for tacrolimus. Twenty-seven 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 list27
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tacrolimus

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, 2013RXYes► subscribe► subscribe
Fougera Pharms Inc
TACROLIMUS
tacrolimus
OINTMENT;TOPICAL200744-002Sep 9, 2014RXNo► subscribe► subscribe
Sandoz
TACROLIMUS
tacrolimus
CAPSULE;ORAL065461-001Aug 10, 2009RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 19945,260,301► subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 20005,665,727► subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 20005,385,907► subscribe
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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► subscribe
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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
European Patent Office1663216► subscribe
South Korea20030040556► subscribe
South Korea20040007751► subscribe
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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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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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