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.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for FARXIGA
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 75 |
| Clinical Trials: | 21 |
| 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
*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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 FARXIGA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ➤ Sign Up | ➤ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ➤ Sign Up | ➤ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ➤ Sign Up | ➤ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ➤ Sign Up | ➤ Sign Up |
| 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 | ➤ Sign Up |
International Patents for FARXIGA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201546054 | ➤ Sign Up |
| Japan | 2012207037 | ➤ Sign Up |
| Mexico | PA02003625 | ➤ Sign Up |
| Colombia | 6160299 | ➤ Sign Up |
| Russian Federation | 2004137489 | ➤ Sign Up |
| South Korea | 20050004161 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for FARXIGA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2012000028 | Germany | ➤ Sign Up | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 00526 | Netherlands | ➤ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 6 5005-2013 | Slovakia | ➤ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112 |
| 0130006 00074 | Estonia | ➤ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012 |
| 2014 00037 | Denmark | ➤ Sign Up | PRODUCT 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 |
| 2012 00015 | Denmark | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
