Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Fuji
Moodys
Novartis
Express Scripts
Accenture
Farmers Insurance
Argus Health
US Army

Generated: October 24, 2017

DrugPatentWatch Database Preview

Tacrolimus - Generic Drug Details

« Back to Dashboard

What are the generic sources for tacrolimus and what is the scope of tacrolimus freedom to operate?

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 and twenty 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

US Patents:17
Tradenames:5
Applicants:12
NDAs:14
Drug Master File Entries: see list20
Suppliers / Packagers: see list27
Bulk Api Vendors: see list54
Clinical Trials: see list923
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
Sandoz
TACROLIMUS
tacrolimus
CAPSULE;ORAL065461-003Aug 10, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 1994APRXYesYes► Subscribe► Subscribe► 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;ORAL206406-001Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Mylan
TACROLIMUS
tacrolimus
CAPSULE;ORAL090596-003Sep 17, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Astellas
ASTAGRAF XL
tacrolimus
CAPSULE, EXTENDED RELEASE;ORAL204096-003Jul 19, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Accord Hlthcare
TACROLIMUS
tacrolimus
CAPSULE;ORAL091195-001Aug 31, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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;TOPICAL050777-001Dec 8, 2000► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-001Dec 8, 2000► Subscribe► Subscribe
Leo Pharma As
PROTOPIC
tacrolimus
OINTMENT;TOPICAL050777-002Dec 8, 2000► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
9,763,920Solid dispersions comprising tacrolimus► Subscribe
9,757,362Modified release compositions comprising tacrolimus► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: tacrolimus

Country Document Number Estimated Expiration
Poland193244► Subscribe
MontenegroP30008► Subscribe
Canada2322516► Subscribe
Russian Federation2011104205► Subscribe
Israel138466► Subscribe
Portugal1663217► Subscribe
HungaryE028847► Subscribe
Hungary0101237► Subscribe
Norway20061430► Subscribe
Lithuania2167033► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
Express Scripts
Farmers Insurance
Baxter
QuintilesIMS
Dow
Chinese Patent Office
Harvard Business School
Johnson and Johnson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot