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Serving 500+ biopharmaceutical companies globally:

Cerilliant
US Department of Justice
Deloitte
AstraZeneca
McKesson
Queensland Health
Farmers Insurance
UBS
Chinese Patent Office
Cipla

Generated: September 21, 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 tacrolimus patent protection?

Tacrolimus
is the generic ingredient in five branded drugs marketed by Hospira Inc, 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 fourteen 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 one hundred 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

Tradenames:5
Patents:17
Applicants:12
NDAs:14
Drug Master File Entries: see list20
Suppliers / Packagers: see list27
Bulk Api Vendors: see list54
Clinical Trials: see list918
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
Astellas
ASTAGRAF XL
tacrolimus
CAPSULE, EXTENDED RELEASE;ORAL204096-001Jul 19, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Astellas
ASTAGRAF XL
tacrolimus
CAPSULE, EXTENDED RELEASE;ORAL204096-001Jul 19, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Accord Hlthcare
TACROLIMUS
tacrolimus
CAPSULE;ORAL091195-001Aug 31, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
TACROLIMUS
tacrolimus
CAPSULE;ORAL090596-001Sep 17, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708-001Apr 8, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe
Strides Pharma
TACROLIMUS
tacrolimus
CAPSULE;ORAL090687-002Jul 22, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Panacea Biotec Ltd
TACROLIMUS
tacrolimus
CAPSULE;ORAL090802-003Sep 28, 2012ABRXNoNo► Subscribe► 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, 1994► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 2000► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 2000► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-001Dec 8, 2000► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-001Dec 8, 2000► Subscribe► 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
Taiwan570814► Subscribe
European Patent Office2167033► Subscribe
BrazilPI0413927► Subscribe
Taiwan200306867► Subscribe
Germany69942286► Subscribe
Indonesia27825► Subscribe
Russian Federation2214244► Subscribe
South Korea100440553► Subscribe
China101869561► Subscribe
Portugal2198858► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
Accenture
Fish and Richardson
Merck
Farmers Insurance
UBS
Cipla
Moodys
Chubb
McKesson

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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