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 |
| Beijing Tsinghua Changgeng Hospital | Phase 2 |
| Shenyang Tenth People's 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 | 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 | ⤷ 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 | ⤷ 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 |
|---|---|---|---|
| Japan | 4777887 | ⤷ Try a Trial | |
| New Zealand | 602997 | 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 |
| 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 |
| Uruguay | 33290 | PROCEDIMIENTO PARA PREPARAR 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}N-METILPIRIDIN-2-CARBOXAMIDA, SUS SALES Y MONOHIDRATO | ⤷ Try a Trial |
| European Patent Office | 2129376 | Traitement de cancers à résistance acquise aux inhibiteurs KIT (Treatment of cancers with acquired resistance to KIT inhibitors) | ⤷ 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 | 122013000086 | Germany | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
| 1663978 | 2013/050 | Ireland | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
| 1663978 | 2013C/067 | Belgium | ⤷ Try a Trial | PRODUCT NAME: STIVARGA-REGORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/13/858 20130829 |
| 1663978 | 92300 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA) |
| 2097381 | C02097381/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62808 15.03.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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