Regorafenib - Generic Drug Details
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What are the generic drug sources for regorafenib and what is the scope of freedom to operate?
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: | 249 |
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*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
Xencor, Inc. | Phase 2 |
Shenyang Tenth People's Hospital | Phase 2 |
Beijing Tsinghua Changgeng Hospital | Phase 2 |
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 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for regorafenib
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Malaysia | 142799 | FLUORO SUBSTITUTED OMEGA-CARBOXYARYL DIPHENYL UREA FOR THE TREATMENT AND PREVENTION OF DISEASES AND CONDITIONS | ⤷ Try a Trial |
Canada | 2796238 | PROCEDE DE PREPARATION DE 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)-PHENYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE, SES SELS ET SON MONOHYDRATE (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) | ⤷ Try a Trial |
Japan | 2013523851 | ⤷ Try a Trial | |
Cuba | 20120147 | PROCEDIMIENTO PARA LA PREPARACIÓN DE 4-{ 4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENIXI}-N-METILPIRIDINA-2-CARBOXAMIDA Y SU MONOHIDRATO | ⤷ Try a Trial |
Guatemala | 200400140 | OMEGA-CARBOXIARIL DIFENIL UREA SUSTITUIDA CON FLUORO PARA EL TRATAMIENTO Y LA PREVENCION DE ENFERMEDADES Y CONDICIONES | ⤷ Try a Trial |
Spain | 2429107 | ⤷ Try a Trial | |
Costa Rica | 8212 | OMEGA-CARBOXIARIL-DIFENIL-UREA SUSTITUIDA CON FLUOR PARA EL TRATAMIENTO Y LA PREVENCION DE ENFERMEDADES Y AFECCIONES | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for regorafenib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663978 | C01663978/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: BAYER HEALTHCARE LLC, US |
1663978 | 1390050-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28 |
1663978 | CR 2013 00056 | Denmark | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826 |
1663978 | 56/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829 |
1663978 | 92300 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA) |
1663978 | C 2014 007 | Romania | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB SI SARURILE SALE4-[4-({[4-CLORO-3-(TRIFLUOROMETIL)-FENIL]CARBAMOIL}AMINO)-TIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/858; DATE OF FIRST AUTHORISATION IN EEA: 20130826 3-FLUOROFENOXI]-N-METILPIRIDIN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/13/858; DATE OF NA |
1663978 | 475 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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