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GLUMETZA Drug Profile

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Which patents cover Glumetza, and what substitute generic drugs are available?

Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in nineteen countries.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-seven drug master file entries for this compound. Ninety-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for Tradename: GLUMETZA

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list45
Clinical Trials: see list32
Patent Applications: see list6,414
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:GLUMETZA at DailyMed

Pharmacology for Tradename: GLUMETZA

Ingredient-typeBiguanides
Drug ClassBiguanide
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005RXYesYes6,488,962► SubscribeYY ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005RXYesNo6,488,962► SubscribeYY ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005RXYesNo6,340,475► SubscribeYY ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005RXYesYes7,780,987► SubscribeYY ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005RXYesYes8,323,692► SubscribeY ► Subscribe
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Expired Patents for Tradename: GLUMETZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,635,280► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,635,280► Subscribe
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Paragraph IV activity for: GLUMETZA

Drugname Dosage Strength RLD Submissiondate
metformin hydrochlorideExtended-release Tablets500 mg and 1000 mgGlumetza7/27/2009

Non-Orange Book Patents for Tradename: GLUMETZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,005,182,056► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: GLUMETZA

Country Document Number Estimated Expiration
European Patent Office1476139► Subscribe
Austria536863► Subscribe
Japan4083818► Subscribe
Australia2003211145► Subscribe
Japan2013006863► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GLUMETZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2014 00037Denmark► SubscribePRODUCT 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
00524Netherlands► SubscribePRODUCT 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:
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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