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KOMBIGLYZE XR Drug Profile

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Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in thirty-five countries.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Summary for Tradename: KOMBIGLYZE XR

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: KOMBIGLYZE XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXNoRE44186► subscribeYY ► subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYes► subscribe► subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXNo► subscribe► subscribe
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Paragraph IV activity for: KOMBIGLYZE XR

Drugname Dosage Strength RLD Submissiondate
saxagliptin hydrochloride and metformin hydrochlorideExtended-release Tablets5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mgKombiglyze XR7/31/2013

Non-Orange Book Patents for Tradename: KOMBIGLYZE XR

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
7,951,400Coated tablet formulation and method► subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► 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: KOMBIGLYZE XR

Country Document Number Estimated Expiration
Japan4901727► subscribe
Norway2012009► subscribe
Japan2014040486► 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: KOMBIGLYZE XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00007Denmark► subscribe
/2008Austria► subscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
90013-0Sweden► subscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
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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 verifification 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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