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GLUMETZA Drug Profile
» See Plans and Pricing
When do Glumetza patents expire, and what generic alternatives are available?
Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-six patent family members in eighteen countries.
The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
US ANDA 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: | 56 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 59 |
| Clinical Trials: | 42 |
| Patent Applications: | 4,455 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GLUMETZA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLUMETZA |
| DailyMed Link: | GLUMETZA at DailyMed |
Recent Clinical Trials for GLUMETZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alberta | Phase 2 |
| St. Justine's Hospital | Phase 2 |
| Bristol-Myers Squibb | Phase 2 |
Pharmacology for GLUMETZA
| Drug Class | Biguanide |
Paragraph IV (Patent) Challenges for GLUMETZA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GLUMETZA | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride | 021748 | 2009-07-27 |
US Patents and Regulatory Information for GLUMETZA
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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 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 | Start Trial | Start Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | Start Trial | Start Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-002 | Jun 3, 2005 | Start Trial | Start Trial |
| Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLUMETZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1294363 | Start Trial |
| Japan | 2013006863 | Start Trial |
| Cyprus | 1112517 | Start Trial |
| European Patent Office | 2260832 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GLUMETZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1412357 | 77 5006-2008 | Slovakia | Start Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408 |
| 1506211 | 300677 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
| 1506211 | C300677 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
| 1412357 | C300357 | Netherlands | Start Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
