1Director, SRS Pharmaceuticals Pvt. Ltd, Mumbai.
2Manager, R&D (Projects), SRS Pharmaceuticals Pvt. Ltd, Mumbai.
3Manager, Intellectual Property Management, SRS Pharmaceuticals Pvt. Ltd, Mumbai
Dapagliflozin is oral sodium-glucose cotransporter 2 (SGLT2) inhibitor class of antidiabetic agent. It is commercially available as tablet with 5 mg & 10mg under the brand name Farxiga by Astrazeneca. Dapagliflozin is protected by several patents and the same has been listed in US Food and Drug Administration orange book database. The molecule patent expired on April 6, 2026 in United States opens the door for generic players. There are 15 first to filer generic players who launched their generic Dapagliflozin tablet product followed by molecule patent expiration. Therefore, the molecule patent is the main primary barrier for generic players to enter the market before expiration of secondary patents such as polymorph, method of treatment, formulation.
Dapagliflozin is antidiabetic agent belonging to class of sodium-glucose cotransporter 2 (SGLT2) inhibitors, helping the kidneys remove excess glucose and sodium from the body. Dapagliflozin is approved in US & Europe as tablet in two strengths 5mg & 10mg. Type 2 diabetes affects over 40 million Americans, with the vast majority (90–95%) diagnosed with this form of the disease. Expanding access to proven therapies can have a meaningful impact on long-term outcomes [1]. The US Food & Drug administration Dapagliflozin (Farxiga) tablet approval details mentioned in table 01 as below.
Table 01: Dapagliflozin (Farxiga) tablet US approval details [2-5]
|
Active ingredient |
Dapagliflozin |
||
|
Brand name & New Drug Application number |
Farxiga [N202293] |
||
|
Dosage form & strength |
Tablet (5mg & 10mg) |
||
|
Approval date |
Jan 08, 2014 |
||
|
Innovator |
Astrazeneca AB |
||
|
Indications & Usage |
(i) Chronic kidney disease at risk of progression, (ii) To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure, (iii) To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and (iv) type 2 diabetes mellitus. |
||
|
Total Sales |
US $ 10.53 billion [MAT Dec 2025] |
||
|
Authorized Generic Sale |
US $ 738.4 million [MAT Dec 2025] |
||
|
Approved generics (First to filers) |
15 FTF ANDA filers received final approved: Aizant, Ajanta, Alembic, Alkem, Apotex, Aurobindo, Biocon, Bionpharma, Cipla, Glenmark, Hetero, Inventia, Lupin, Macleods, Micro, MSN, Sandoz, Sun Pharma, Teva and Zydus 05 FTF ANDA filers tentatively approved: Apotex, Bionpharma, Glenmark Generics, Hetero and Sun Pharma |
||
|
Other ANDA filers |
Jiangsu, ScieGen and Others |
||
|
Authorized Generic |
Prasco Labs |
||
|
Active US Drug Master File holders (USDMF) [4] |
More than 60 Active USDMF holders: MSN, Dr. Reddys, Lupin, Zydus, Alembic Pharma, Sun Pharma, Biocon, USV and others |
||
|
Patent protection – orange book listed patents [5] |
There are 11 patents listed in orange book against Farxiga tablet (5mg & 10mg) as on May 12, 2026. |
||
|
Patent No. |
Expiry date |
Type of patent |
|
|
US6515117 |
Apr 04, 2026 |
Compound/ molecule |
|
|
US7851502 |
Feb 19, 2029 |
Formulation - Tablet |
|
|
US7919598 |
Jun 16, 2030 |
Polymorph |
|
|
US8501698 |
Dec 20, 2027 |
Polymorph & their composition |
|
|
US8221786/ US8361972/ US8716251 |
Sep 21, 2028 |
Formulation - Tablet |
|
|
US8329648/ US8906851 |
Feb 18, 2027 |
Treatment |
|
|
US8685934 |
Nov 26, 2030 |
Treatment |
|
|
US8721615 |
Jul 18, 2030 |
Device – irrelevant (Delist requested) |
|
Patent Expiry and Generic Entry in United States Market:
The US Food and Drug Administration (FDA) approved over 15 generic versions of Farxiga (dapagliflozin) tablets on April 6, 2026, instantly following the expiration of the compound or molecule patent on April 4, 2026 with pediatric exclusivity (US6515117). Most of the generics enter in the market by following paragraph-III certification against molecule patent and paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the FD&C Act stating that the patents are invalid, unenforceable, or will not be infringed by generic companies against formulation patent which are expiring in 2029/ 2030.
Table 02: Dapagliflozin (Farxiga) tablet generic approval details [3]
|
S/N |
Generic company name |
ANDA Number |
Approval date |
Type of approval |
|
|
Inevntia |
A211156 |
Apr 06, 2026 |
Final approval |
|
|
Sandoz |
A211312 |
Apr 06, 2026 |
Final approval |
|
|
Micro Labs |
A211467 |
Apr 06, 2026 |
Final approval |
|
|
Aurobindo Pharma |
A211468 |
Apr 06, 2026 |
Final approval |
|
|
Biocon Pharma |
A211470 |
Apr 06, 2026 |
Final approval |
|
|
MSN |
A211478 |
Apr 06, 2026 |
Final approval |
|
|
Ajanta Pharma |
A211482 |
Apr 06, 2026 |
Final approval |
|
|
Macleods Pharma |
A211506 |
Apr 06, 2026 |
Final approval |
|
|
Aizant |
A211523 |
Apr 06, 2026 |
Final approval |
|
|
Lupin |
A211531 |
Apr 06, 2026 |
Final approval |
|
|
Cipla |
A211535 |
Apr 06, 2026 |
Final approval |
|
|
Teva Pharma |
A211541 |
Apr 06, 2026 |
Final approval |
|
|
Alkem Lab |
A211545 |
Apr 06, 2026 |
Final approval |
|
|
Alembic |
A211560 |
Apr 06, 2026 |
Final approval |
|
|
Zydus Pharma |
A211582 |
Apr 06, 2026 |
Final approval |
|
|
Apotex |
A211442 |
Jan 04, 2019 |
Tentative approval |
|
|
Hetero Labs |
A211439 |
Jan 18, 2019 |
Tentative approval |
|
|
Sun Pharma |
A211416 |
Aug 21, 2019 |
Tentative approval |
|
|
Glenmark Generics |
A211564 |
Mar 20, 2030 |
Tentative approval |
|
|
Bionpharma |
A211414 |
Dec 17, 2020 |
Tentative approval |
|
|
Jiangsu Hansoh Pharm |
A216119 |
Apr 02, 2026 |
Tentative approval |
|
|
Sciegen Pharma |
A219408 |
Apr 30, 2026 |
Tentative approval |
CONCLUSION:
The primary molecule patent is the main barrier for generic launch. Once the molecule patent expires several generic players are ready with their product to launch on day one followed by patent expiry. Dapagliflozin continues to be a high-value molecule given its strong positioning in diabetes, heart failure, and chronic kidney disease segments. The upcoming phase could significantly reshape market competition and accessibility. Similar to the 2025 Indian market entry of generic competitors, the US market is expected to see significant price competition, with more than 60 active Drug Master Files (DMFs) for dapagliflozin in the US.
REFERENCES
Pooja Deshpande, Dinesh Dantkale, Sharad Rode*, Dapagliflozin Tablet Patents and Generic Launch: Recent Developments, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 4818-4821. https://doi.org/10.5281/zenodo.20284031
10.5281/zenodo.20284031
