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Serving leading biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Cerilliant
Mallinckrodt
UBS
Federal Trade Commission
Daiichi Sankyo
Johnson and Johnson
Fuji
Chinese Patent Office

Generated: January 22, 2018

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, Dr Reddys Labs Ltd, and Zydus Pharms Usa Inc, 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 twenty drug master file entries for sirolimus. Seven suppliers are listed for this compound.

US Patents and Regulatory Information for sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-001 Oct 27, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-002 Oct 27, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc SIROLIMUS sirolimus TABLET;ORAL 201676-003 Jan 8, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Cerilliant
Accenture
Moodys
Daiichi Sankyo
Federal Trade Commission
Deloitte
Baxter
Julphar
Cipla

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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