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 |
| DailyMed Link: | PRANDIMET at DailyMed |
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 | 022386-002 | 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 |
| 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 |
|---|---|---|---|
| Finland | 845145 | ⤷ Sign Up | |
| Spain | 8802145 | ⤷ Sign Up | |
| Australia | 587263 | ⤷ Sign Up | |
| Australia | 3721084 | ⤷ Sign Up | |
| Australia | 7906898 | ⤷ Sign Up | |
| Spain | 539078 | ⤷ Sign Up | |
| Germany | 69800806 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRANDIMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | 15/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 |
| 1261586 | C300524 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
| 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/ |
| 0147850 | 99C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817 |
| 1532149 | CA 2013 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
| 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 |
| 1412357 | PA2008013,C1412357 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
| >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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