Empagliflozin; metformin hydrochloride - Generic Drug Details
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What are the generic sources for empagliflozin; metformin hydrochloride and what is the scope of patent protection?
Empagliflozin; metformin hydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Empagliflozin; metformin hydrochloride has two hundred and forty-nine patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for empagliflozin; metformin hydrochloride
International Patents: | 249 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 62 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for empagliflozin; metformin hydrochloride |
DailyMed Link: | empagliflozin; metformin hydrochloride at DailyMed |
Recent Clinical Trials for empagliflozin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tanta University | Phase 3 |
Handok Inc. | Phase 3 |
Karolinska Institutet | N/A |
See all empagliflozin; metformin hydrochloride clinical trials
Pharmacology for empagliflozin; metformin hydrochloride
Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for empagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SYNJARDY | Tablets | empagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg | 206111 | 4 | 2018-08-01 |
SYNJARDY XR | Extended-release Tablets | empagliflozin; metformin hydrochloride | 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | 208658 | 3 | 2018-08-01 |
US Patents and Regulatory Information for empagliflozin; metformin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-004 | Aug 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-004 | Aug 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | 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 empagliflozin; metformin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for empagliflozin; metformin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 563563 | Crystalline form of 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments | ⤷ Try a Trial |
Serbia | 55588 | FARMACEUTSKA KOMPOZICIJA, FARMACEUTSKI DOZNI OBLIK, POSTUPAK ZA NJIHOVO DOBIJANJE, POSTUPCI LEČENJA I NJIHOVA PRIMENA (PHARMACEUTICAL COMPOSITION, PHARMACEUTICAL DOSAGE FORM, PROCESS FOR THEIR PREPARATION, METHODS FOR TREATING AND USES THEREOF) | ⤷ Try a Trial |
Lithuania | 2981271 | ⤷ Try a Trial | |
India | 2805DEN2012 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for empagliflozin; metformin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | SPC/GB14/070 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 20140527 |
1730131 | 1490061-7 | Sweden | ⤷ Try a Trial | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
1730131 | C01730131/04 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021 |
1730131 | PA2014035 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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