CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for canagliflozin; metformin hydrochloride and what is the scope of patent protection?
Canagliflozin; metformin hydrochloride
is the generic ingredient in two branded drugs marketed by Janssen Pharms and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Canagliflozin; metformin hydrochloride has two hundred and sixty-nine patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
International Patents: | 269 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 50 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
DailyMed Link: | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Generic Entry Dates for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
Generic Entry Dates for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE*:
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 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ain Shams University | Phase 1/Phase 2 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
Johnson & Johnson Private Limited | Phase 4 |
See all CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials
Pharmacology for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INVOKAMET XR | Extended-release Tablets | canagliflozin; metformin hydrochloride | 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg | 205879 | 1 | 2018-11-21 |
INVOKAMET | Tablets | canagliflozin; metformin hydrochloride | 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg | 204353 | 6 | 2017-03-29 |
US Patents and Regulatory Information for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Expired US Patents for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-001 | Sep 20, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-001 | Sep 20, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-002 | Sep 20, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVOKAMET | canagliflozin; metformin hydrochloride | TABLET;ORAL | 204353-003 | Aug 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-004 | Sep 20, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200524950 | Substituted indazole-O-glucosides | ⤷ Sign Up |
Ukraine | 83377 | N-ГЛИКОЗИД, СПОСОБ ЕГО ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ;N-ГЛІКОЗИД, СПОСІБ ЙОГО ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ТА СПОСІБ ЛІКУВАННЯ (N- GLYCOSIDE, PROCESS FOR THE PREPARATION THEREOF, PHARMACEUTICAL COMPOSITION AND TREATMENT METHOD) | ⤷ Sign Up |
Japan | 5317951 | ⤷ Sign Up | |
Malaysia | 143203 | NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDENT TRANSPORTER | ⤷ Sign Up |
Eurasian Patent Organization | 017103 | КРИСТАЛЛИЧЕСКАЯ ФОРМА ГЕМИГИДРАТА 1-(β-D-ГЛЮКОПИРАНОЗИЛ)-4-МЕТИЛ-3-[5-(4-ФТОРФЕНИЛ)-2-ТИЕНИЛМЕТИЛ]БЕНЗОЛА (CRYSTALLINE FORM OF 1-(&bgr;-D-GLUCOPYRANOSYL)-4-METHYL-3-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL]BENZENE HEMIHYDRATE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1651658 | 300670 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119 |
1651658 | CR 2014 00024 | Denmark | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119 |
1651658 | 637 | Finland | ⤷ Sign Up | |
1651658 | C300670 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118 |
1651658 | SPC/GB14/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CANAGLIFLOZIN; REGISTERED: UK EU/1/13/884/001 20131119; UK EU/1/13/884/002 20131119; UK EU/1/13/884/003 20131119; UK EU/1/13/884/004 20131119; UK EU/1/13/884/005 20131119; UK EU/1/13/884/006 20131119; UK EU/1/13/884/007 20131119; UK EU/1/13/884/008 20131119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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