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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Julphar
Daiichi Sankyo
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Farmers Insurance
Novartis
Cipla
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Generated: November 21, 2017

DrugPatentWatch Database Preview

Sirolimus - Generic Drug Details

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

Sirolimus
is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Zydus Pharms Usa Inc, and Dr Reddys Labs Ltd, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for sirolimus. Seven suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004DISCNYesNo► Subscribe► SubscribeY► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004DISCNYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Dr Reddys Labs Ltd
SIROLIMUS
sirolimus
TABLET;ORAL201578-001Oct 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 1999RXYesYes► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
SIROLIMUS
sirolimus
TABLET;ORAL201578-002Oct 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 1999► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 1999► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
Julphar
Federal Trade Commission
Teva
Chubb
Mallinckrodt
Harvard Business School
Johnson and Johnson
Novartis

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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