GLUMETZA Drug Patent Profile
✉ Email this page to a colleague
When do Glumetza patents expire, and when can generic versions of Glumetza launch?
Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in fourteen countries.
The generic ingredient in GLUMETZA 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 Glumetza
A generic version of GLUMETZA was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for GLUMETZA
International Patents: | 26 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 49 |
Patent Applications: | 579 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for GLUMETZA |
Drug Sales Revenues: | Drug sales revenues for GLUMETZA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLUMETZA |
What excipients (inactive ingredients) are in GLUMETZA? | GLUMETZA excipients list |
DailyMed Link: | GLUMETZA at DailyMed |
Recent Clinical Trials for GLUMETZA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
University of Colorado, Denver | Phase 1 |
St. Jude Children's Research Hospital | Phase 2 |
Pharmacology for GLUMETZA
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for GLUMETZA
Paragraph IV (Patent) Challenges for GLUMETZA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GLUMETZA | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021748 | 1 | 2009-07-27 |
US Patents and Regulatory Information for GLUMETZA
GLUMETZA is protected by one US patents.
Patents protecting GLUMETZA
Controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | 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 GLUMETZA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLUMETZA
See the table below for patents covering GLUMETZA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009040787 | TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM | ⤷ Sign Up |
New Zealand | 523214 | A dosage form of a solid monolithic matrix non-circular in shape having first and second orthoganal axes of unequal length and that swells upon contact with water | ⤷ Sign Up |
European Patent Office | 0998271 | FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE A RETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLUMETZA
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 |