GLUCOPHAGE XR Drug Patent Profile
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Which patents cover Glucophage Xr, and when can generic versions of Glucophage Xr launch?
Glucophage Xr is a drug marketed by Emd Serono Inc and is included in one NDA.
The generic ingredient in GLUCOPHAGE XR is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Glucophage Xr
A generic version of GLUCOPHAGE XR was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for GLUCOPHAGE XR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 347 |
Patent Applications: | 680 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for GLUCOPHAGE XR |
DailyMed Link: | GLUCOPHAGE XR at DailyMed |
Recent Clinical Trials for GLUCOPHAGE XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pakistan Science Foundation | Phase 1 |
Aga Khan University | Phase 1 |
Arab Contractors Medical Centre | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for GLUCOPHAGE XR
US Patents and Regulatory Information for GLUCOPHAGE XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-001 | Oct 13, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | 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 GLUCOPHAGE XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-001 | Oct 13, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLUCOPHAGE XR
See the table below for patents covering GLUCOPHAGE XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 200000968 | ⤷ Sign Up | |
European Patent Office | 1063973 | SYSTEME D'APPORT A LIBERATION LENTE BIPHASIQUE DESTINE A DES MEDICAMENTS A SOLUBILITE ELEVEE ET PROCEDE ASSOCIE (BIPHASIC CONTROLLED RELEASE DELIVERY SYSTEM FOR HIGH SOLUBILITY PHARMACEUTICALS AND METHOD) | ⤷ Sign Up |
New Zealand | 506202 | Biphasic controlled release delivery system for high solubility pharmaceuticals and method | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLUCOPHAGE XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | C01730131/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
1412357 | C 2008 016 | Romania | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
2498758 | LUC00152 | Luxembourg | ⤷ Sign Up | 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 |