KOMBIGLYZE XR Drug Patent Profile
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Which patents cover Kombiglyze Xr, and what generic alternatives are available?
Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-seven patent family members in thirty-two countries.
The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kombiglyze Xr
A generic version of KOMBIGLYZE XR was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9th, 2023.
Summary for KOMBIGLYZE XR
International Patents: | 57 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 2 |
Patent Applications: | 73 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KOMBIGLYZE XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KOMBIGLYZE XR |
DailyMed Link: | KOMBIGLYZE XR at DailyMed |
Recent Clinical Trials for KOMBIGLYZE XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The First Affiliated Hospital of Guangzhou Medical University | Phase 3 |
The University of Hong Kong | Phase 3 |
Karolinska Institutet | Phase 3 |
Pharmacology for KOMBIGLYZE XR
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for KOMBIGLYZE XR
Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KOMBIGLYZE XR | Extended-release Tablets | metformin hydrochloride; saxagliptin hydrochloride | 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg | 200678 | 3 | 2013-07-31 |
US Patents and Regulatory Information for KOMBIGLYZE XR
KOMBIGLYZE XR is protected by two US patents.
Patents protecting KOMBIGLYZE XR
Coated tablet formulation and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Coated tablet formulation and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 KOMBIGLYZE XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KOMBIGLYZE XR
When does loss-of-exclusivity occur for KOMBIGLYZE XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9062
Estimated Expiration: ⤷ Try a Trial
Patent: 9567
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 05249467
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0510419
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 68391
Estimated Expiration: ⤷ Try a Trial
China
Patent: 88891
Estimated Expiration: ⤷ Try a Trial
Patent: 2895208
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0160880
Estimated Expiration: ⤷ Try a Trial
Patent: 0161210
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17813
Estimated Expiration: ⤷ Try a Trial
Patent: 18162
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 53406
Estimated Expiration: ⤷ Try a Trial
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 53406
Estimated Expiration: ⤷ Try a Trial
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
Patent: 78369
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0094639
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 94951
Estimated Expiration: ⤷ Try a Trial
Patent: 55399
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 29039
Estimated Expiration: ⤷ Try a Trial
Patent: 29446
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9454
Estimated Expiration: ⤷ Try a Trial
Patent: 8117
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 01727
Estimated Expiration: ⤷ Try a Trial
Patent: 08501025
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 7639
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06013711
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 516
Estimated Expiration: ⤷ Try a Trial
Patent: 643
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1591
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 3907
Estimated Expiration: ⤷ Try a Trial
Patent: 065870
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060425
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 53406
Estimated Expiration: ⤷ Try a Trial
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 53406
Estimated Expiration: ⤷ Try a Trial
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 72894
Estimated Expiration: ⤷ Try a Trial
Patent: 06146971
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 929
Estimated Expiration: ⤷ Try a Trial
Patent: 174
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 53406
Estimated Expiration: ⤷ Try a Trial
Patent: 98288
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0609541
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1290925
Estimated Expiration: ⤷ Try a Trial
Patent: 070027560
Estimated Expiration: ⤷ Try a Trial
Patent: 120064141
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 82646
Estimated Expiration: ⤷ Try a Trial
Patent: 93582
Estimated Expiration: ⤷ Try a Trial
Patent: 54573
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 54569
Estimated Expiration: ⤷ Try a Trial
Patent: 15635
Estimated Expiration: ⤷ Try a Trial
Patent: 0609002
Estimated Expiration: ⤷ Try a Trial
Patent: 1204414
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 168
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KOMBIGLYZE XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2995615 | INHIBITEURS DE LA DIPEPTIDYL-PEPTIDASE IV COMPRENANT UNE PYRROLIDINE ET UN CYCLOPROPYLE FUSIONNÉS ET LEUR UTILISATION PHARMACEUTIQUE (CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV AND THEIR PHARMACEUTICAL USE) | ⤷ Try a Trial |
Taiwan | 200624420 | ⤷ Try a Trial | |
Portugal | 1261586 | ⤷ Try a Trial | |
Japan | 2014040486 | INHIBITORS OF DIPEPTIDYL PEPTIDASE IV HAVING CYCLOPROPYL-FUSED PYRROLIDINE BACKBONE AND METHOD | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KOMBIGLYZE XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1261586 | 12C0028 | France | ⤷ Try a Trial | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
1261586 | C01261586/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US |
1532149 | 132013902118390 | Italy | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720 |
1261586 | CA 2012 00014 | Denmark | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |