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Generated: April 25, 2017

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Tacrolimus - Generic Drug Details

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

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 seventeen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tacrolimus has ninety-nine patent family members in thirty-four countries.

There are twenty drug master file entries for tacrolimus. Twenty-seven suppliers are listed for this compound.

Summary for Generic Name: tacrolimus

Drug Master File Entries: see list20
Suppliers / Packagers: see list27
Bulk Api Vendors: see list54
Clinical Trials: see list453
Patent Applications: see list9,971
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tacrolimus at DailyMed

Pharmacology for Ingredient: tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms Inc
OINTMENT;TOPICAL200744-001Sep 9, 2014ABRXNoNo► Subscribe► Subscribe
Veloxis Pharms Inc
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes9,161,907► SubscribeY ► Subscribe
Veloxis Pharms Inc
TABLET, EXTENDED RELEASE;ORAL206406-002Jul 10, 2015RXYesNo8,623,410► SubscribeY ► Subscribe
Veloxis Pharms Inc
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXYesNo8,623,410► SubscribeY ► Subscribe
Veloxis Pharms Inc
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXYesNo8,623,411► Subscribe ► Subscribe
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  • Anticipate P&T budget requirements
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  • Identify first generic entrants

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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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