DrugPatentWatch Database Preview
FARXIGA Drug Profile
When do Farxiga patents expire, and when can generic versions of Farxiga launch?
Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and two patent family members in forty-four countries.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for FARXIGA
| International Patents: | 302 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 24 |
| Patent Applications: | 329 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FARXIGA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FARXIGA |
| DailyMed Link: | FARXIGA at DailyMed |
Generic Entry Opportunity Date for FARXIGA
Generic Entry Date for FARXIGA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for FARXIGA
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Synonyms for FARXIGA
| (1S)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-D-glucitol |
| (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol |
| (1S)-1,5-anhydro-1-C-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-D-glucitol |
| (2S, 3R, 4R, 5S, 6R)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2H-pyran-3,4,5-triol;BMS-512148 |
| (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL]-6-(HYDROXYMETHYL)-TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL |
| (2S,3R,4R,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol |
| (2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol |
| 1-[3-(beta-D-Glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene |
| 1ULL0QJ8UC |
| 2-(3-(4-Ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol |
| 432D268 |
| 461432-26-8 |
| A25150 |
| AB1008441 |
| AC-24699 |
| AJ-45726 |
| AK161692 |
| AKOS005145763 |
| AMX10145 |
| AN-431 |
| AOB87300 |
| API0007667 |
| AX8161909 |
| BCP9000583 |
| BCPP000265 |
| BDBM20880 |
| BDBM50448923 |
| BMS 512148 |
| BMS-512148 |
| BMS-512148, 461432-26-8 |
| BMS-512148, Dapagliflozin |
| BMS5121458 |
| BMS512148 |
| C-aryl glucoside, 6 |
| CA000442 |
| CA002484 |
| CCG-229917 |
| CD0219 |
| CHEBI:85078 |
| CHEMBL3125458 |
| CHEMBL429910 |
| CS-0781 |
| D-Glucitol, 1,5-anhydro-1-C-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1S)- |
| D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)- |
| D01TNW |
| D08897 |
| Dapagliflozin |
| Dapagliflozin (INN/USAN) |
| Dapagliflozin (USAN/INN) |
| Dapagliflozin [USAN:INN] |
| dapagliflozin propanediol monohydrate |
| Dapagliflozin propylene glycolate hydrate |
| dapaglifozin |
| DB06292 |
| EX-7214 |
| EX-A005 |
| Forxiga |
| Forxiga (TN) |
| FT-0665469 |
| GLU006 |
| GTPL4594 |
| HY-10450 |
| J-500392 |
| JVHXJTBJCFBINQ-ADAARDCZSA-N |
| KS-000006UW |
| MFCD13182359 |
| MolPort-009-682-875 |
| PB11055 |
| PubChem22435 |
| Q-3845 |
| RL03723 |
| s1548 |
| S1548_Selleck |
| SC-25116 |
| SCHEMBL157820 |
| ST24046416 |
| Tube101 |
| UNII-1ULL0QJ8UC |
| ZINC3819138 |
US Patents and Regulatory Information for FARXIGA
Expired US Patents for FARXIGA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for FARXIGA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 5 mg and 10 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for FARXIGA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201406743 | ➤ Try a Free Trial |
| Russian Federation | 2262507 | ➤ Try a Free Trial |
| European Patent Office | 2435033 | ➤ Try a Free Trial |
| European Patent Office | 2821063 | ➤ Try a Free Trial |
| South Korea | 20070011506 | ➤ Try a Free Trial |
| Hungary | 229446 | ➤ Try a Free Trial |
| Israel | 165119 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for FARXIGA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0526 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 2014026,C1506211 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 136; 5005-2013 | Slovakia | ➤ Try a Free Trial | PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL |
| 8 5006-2012 | Slovakia | ➤ Try a Free Trial | PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623 |
| 2012000028 | Germany | ➤ Try a Free Trial | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 9 5017-2014 | Slovakia | ➤ Try a Free Trial | PRODUCT 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 |
| /2012 | Austria | ➤ Try a Free Trial | PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
