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.
Summary for PRANDIMET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Patent Applications: | 47 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PRANDIMET at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for PRANDIMET
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 PRANDIMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
European Patent Office | 0207331 | SOLID FORMS OF 2-ETHOXY-4-ÛN-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINO-CARBONYLMETHYL ̈-BENZOIC ACID, MEDICAMENTS CONTAINING THESE FORMS AND PROCESS FOR THEIR PREPARATION | ⤷ Try a Trial |
Luxembourg | 90301 | ⤷ Try a Trial | |
Germany | 69800806 | ⤷ Try a Trial | |
South Africa | 9805126 | ⤷ Try a Trial | |
Finland | 82689 | ⤷ Try a Trial | |
Hungary | 196193 | PROCESS FOR PRODUCING NEW PHENYL-ACETIC-ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRANDIMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | 16/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113 |
0147850 | 99C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817 |
2498758 | 122020000018 | Germany | ⤷ Try a Trial | 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 |
1412357 | CA 2008 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
1506211 | CA 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
1412357 | PA2008013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |