PRANDIMET Drug Patent Profile
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Which patents cover Prandimet, and when can generic versions of Prandimet launch?
Prandimet is a drug marketed by Novo Nordisk Inc and is included in one NDA.
The generic ingredient in PRANDIMET is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
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Summary for PRANDIMET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Patent Applications: | 38 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PRANDIMET at DailyMed |
![PRANDIMET drug patent expirations Drug patent expirations by year for PRANDIMET](/p/graph/s/t/PRANDIMET-patent-expirations.png)
Paragraph IV (Patent) Challenges for PRANDIMET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PRANDIMET | Tablets | metformin hydrochloride; repaglinide | 1 mg/500 mg and 2 mg/500 mg | 022386 | 1 | 2009-04-09 |
US Patents and Regulatory Information for PRANDIMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 PRANDIMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRANDIMET
See the table below for patents covering PRANDIMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 7906898 | ⤷ Sign Up | |
German Democratic Republic | 231348 | VERFAHREN ZUR HERSTELLUNG VON NEUEN PHENYLESSIGSAEUREDERIVATEN | ⤷ Sign Up |
Portugal | 82832 | PROCESSO PARA PREPARACAO DE NOVAS FORMAS SOLIDAS DE ACIDO 2-ETOXI-4-{N-1-(2-PIPERIDINO-FENIL)-3-METIL-1-BUTIL)-AMINOCARBONILMETIL}-BENZOICO E DE COMPOSICOES FARMACEUTICAS QUE AS CONTEM | ⤷ Sign Up |
Czechoslovakia | 9104097 | ⤷ Sign Up | |
Luxembourg | 90301 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRANDIMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | CR 2020 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
0147850 | SPC/GB98/042 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/ |
1506211 | C01506211/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015 |
1730131 | C01730131/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
2498758 | 122020000018 | Germany | ⤷ Sign Up | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |