Regorafenib - Generic Drug Details

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What are the generic sources for regorafenib and what is the scope of patent protection?

Regorafenib is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regorafenib has one hundred and sixty-seven patent family members in forty-eight countries.

There are two drug master file entries for regorafenib. One supplier is listed for this compound.

Summary for regorafenib

International Patents:	167
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	257
Patent Applications:	6,497
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regorafenib
What excipients (inactive ingredients) are in regorafenib?	regorafenib excipients list
DailyMed Link:	regorafenib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for regorafenib

Generic Entry Date for regorafenib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 regorafenib

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

Sponsor	Phase
Peking University	N/A
Xencor, Inc.	Phase 2
Neonc Technologies, Inc.	Phase 1/Phase 2

See all regorafenib clinical trials

Pharmacology for regorafenib

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Kinase Inhibitors UGT1A1 Inhibitors UGT1A9 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for regorafenib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for REGORAFENIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIVARGA	Tablets	regorafenib	40 mg	203085	2	2016-09-27

US Patents and Regulatory Information for regorafenib

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Glossary

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

Expired US Patents for regorafenib

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for regorafenib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer Pharma AG	Stivarga	regorafenib	EMEA/H/C/002573 Stivarga is indicated as monotherapy for the treatment of adult patients with:metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.	Authorised	no	no	no	2013-08-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for regorafenib

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Country	Patent Number	Title	Estimated Expiration
Israel	222348	תהליך להכנת 4-{4-[({[4--כלורו-3-(טריפלואורומתיל)-פניל]אמינו}קרבוניל)אמינו]-3-פלואורופנוקסי}-n-מתילפירידין-2-קרבוקסאמיד, מלחיו ומונוהידראט שלו (Process for the preparation of 4- {4-[({[4 -chloro-3 -(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorophenoxy}-n-methylpyridine-2-carboxamide, its salts and monohydrate)	⤷ Sign Up
Japan	5505906		⤷ Sign Up
Argentina	079933	FORMULACIONES QUE COMPRENDEN OMEGA-CARBOXIARIL DIFENIL UREA SUSTITUIDA CON FLUORO EN COMBINACION CON UN AGENTE ANTICANCERIGENO ADICIONAL PARA EL TRATAMIENTO Y LA PREVENCION DE UNA ENFERMEDAD HIPERPROLIFERATIVA.	⤷ Sign Up
Uruguay	39590	PROCEDIMIENTO PARA PREPARAR 4-{4-[({[4-CLORO-3- (TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}N- METILPIRIDIN-2-CARBOXAMIDA, MONOHIDRATO Y COMPOSICIONES QUE LO COMPRENDEN	⤷ Sign Up
Malaysia	152595	4-[4-({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL}AMINO)-3-FLUOROPHENOXY]-N-METHYLPYRIDINE-2-CARBOXAMIDE MONOHYDRATE	⤷ Sign Up
Eurasian Patent Organization	010485	ПРОИЗВОДНОЕ N,N'-ДИФЕНИЛМОЧЕВИНЫ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ И ПРЕДУПРЕЖДЕНИЯ ЗАБОЛЕВАНИЙ И СОСТОЯНИЙ С ЕГО ИСПОЛЬЗОВАНИЕМ (ВАРИАНТЫ) (N,N-DIPHENYL UREA DERIVATIVE, PHARMACEUTICAL COMPOSITION (EMBODIMENTS) THEREOF, AND METHOD FOR THE TREATMENT AND PREVENTION OF DISEASES AND CONDITIONS USING IT (EMBODIMENTS))	⤷ Sign Up
South Korea	20130061670	PROCESS FOR THE PREPARATION OF 4- {4- [ ( { [4-CHLORO-3- (TRIFLUOROMETHYL) -PHENYL]AMINO} CARBONYL) AMINO]-3-FLUOROPHENOXY} -N-METHYLPYRIDINE-2-CARBOXAMIDE, ITS SALTS AND MONOHYDRATE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for regorafenib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	92300	Luxembourg	⤷ Sign Up	PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
1663978	56/2013	Austria	⤷ Sign Up	PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
1663978	2013/050	Ireland	⤷ Sign Up	PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978	C20130034 00099	Estonia	⤷ Sign Up	PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
1663978	149 13-2013	Slovakia	⤷ Sign Up	FIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
1663978	C300620	Netherlands	⤷ Sign Up	PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978	2013C/067	Belgium	⤷ Sign Up	PRODUCT NAME: STIVARGA-REGORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/13/858 20130829
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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