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Last Updated: April 14, 2021

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STIVARGA Drug Profile

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When do Stivarga patents expire, and when can generic versions of Stivarga launch?

Stivarga is a drug marketed by Bayer Hlthcare and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-eight patent family members in fifty-eight countries.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

DrugPatentWatch® Generic Entry Outlook for Stivarga

Stivarga was eligible for patent challenges on September 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 8, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for STIVARGA
Drug Prices for STIVARGA

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for STIVARGA
Generic Entry Date for STIVARGA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for STIVARGA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre Hospitalier Universitaire de BesanconPhase 2
SC Liver Research Consortium, LLCPhase 2
National Cancer Institute (NCI)Phase 1

See all STIVARGA clinical trials

Pharmacology for STIVARGA
Paragraph IV (Patent) Challenges for STIVARGA
Tradename Dosage Ingredient NDA Submissiondate
STIVARGA TABLET;ORAL regorafenib 203085 2016-09-27

US Patents and Regulatory Information for STIVARGA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for STIVARGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663978 56/2013 Austria   Start Trial PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
1663978 C20130034 00099 Estonia   Start Trial PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
1140840 SPC 031/2006 Ireland   Start Trial SPC 031/2006: 20070528, EXPIRES: 20210718
1663978 13C0060 France   Start Trial PRODUCT NAME: REGORAFENIB ET SES SELS; REGISTRATION NO/DATE: EU/1/13/858/001-002 20130826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 verification 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.