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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Accenture
Queensland Health
Cipla
Johnson and Johnson
US Department of Justice
Covington
Medtronic
Julphar

Generated: February 22, 2018

DrugPatentWatch Database Preview

Tacrolimus - Generic Drug Details

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What are the generic drug sources for tacrolimus and what is the scope of tacrolimus patent protection?

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

Tacrolimus has one hundred and twenty-five patent family members in thirty-four countries.

There are twenty drug master file entries for tacrolimus. Twenty-four suppliers are listed for this compound.
Pharmacology for tacrolimus
Medical Subject Heading (MeSH) Categories for tacrolimus

US Patents and Regulatory Information for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz TACROLIMUS tacrolimus CAPSULE;ORAL 065461-002 Aug 10, 2009 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fougera Pharms Inc TACROLIMUS tacrolimus OINTMENT;TOPICAL 200744-001 Sep 9, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Strides Pharma TACROLIMUS tacrolimus CAPSULE;ORAL 090687-002 Jul 22, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for tacrolimus

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Julphar
Covington
Cipla
Moodys
AstraZeneca
McKinsey
Cerilliant
Daiichi Sankyo

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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