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 |
|---|---|---|---|
| Germany | 3347565 | ⤷ Try a Trial | |
| Germany | 3523466 | ⤷ Try a Trial | |
| Finland | 862650 | ⤷ Try a Trial | |
| Canada | 1225398 | DERIVES DE L'ACIDE PHENYLACETIQUE, COMPOSES PHARMACEUTIQUES LES CONTENANT ET PROCEDE DE PREPARATION (PHENYLACETIC ACID DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THESE COMPOUNDS AND PROCESSES FOR PREPARING THEM) | ⤷ Try a Trial |
| Greece | 861558 | METHOD FOR PREPARING NEW SOLID FORMS OF 2-ATHOXY-4-(N-(1,2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZO ACID | ⤷ Try a Trial |
| Spain | 545879 | ⤷ 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 |
|---|---|---|---|---|
| 1506211 | 42/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
| 2498758 | CR 2020 00017 | Denmark | ⤷ Try a Trial | 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 |
| 1261586 | 132012902044560 | Italy | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124 |
| 1506211 | CR 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 |
| 2498758 | 301040 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113 |
| 2498758 | LUC00152 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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