drug
(dapagliflozin + metformin hydrochloride) ER
Marketedupdated 3mo agoby AstraZeneca Pharmaceuticals LP
Approvedcommunity read0 votes
indications
investigational
Type 2 Diabetes
all catalysts(0)
nothing on the calendar yet
Trials studying (dapagliflozin + metformin hydrochloride) ER
- phase1A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
- phase1A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 12, 2027
305 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (50)
- May 12, 2031patentUS 9616028*PED4.8y
- May 12, 2031patentUS 9616028*PED4.8y
- May 12, 2031patentUS 9616028*PED4.8y
- May 12, 2031patentUS 9616028*PED4.8y
- May 12, 2031patentUS 9616028*PED4.8y
- Nov 26, 2030patentUS 8685934*PED4.3y
- Nov 26, 2030patentUS 8685934*PED4.3y
- Nov 26, 2030patentUS 8685934*PED4.3y
- Nov 26, 2030patentUS 8685934*PED4.3y
- Nov 26, 2030patentUS 8685934*PED4.3y
- Nov 12, 2030formulationUS 96160284.3y
- Nov 12, 2030formulationUS 96160284.3y
- Nov 12, 2030formulationUS 96160284.3y
- Nov 12, 2030formulationUS 96160284.3y
- Nov 12, 2030formulationUS 96160284.3y
- Jun 16, 2030patentUS 7919598*PED3.8y
- Jun 16, 2030patentUS 7919598*PED3.8y
- Jun 16, 2030patentUS 7919598*PED3.8y
- Jun 16, 2030patentUS 7919598*PED3.8y
- Jun 16, 2030patentUS 7919598*PED3.8y
- May 26, 2030method-of-use (U-1522)US 86859343.8y
- May 26, 2030method-of-use (U-1522)US 86859343.8y
- May 26, 2030method-of-use (U-1522)US 86859343.8y
- May 26, 2030method-of-use (U-1522)US 86859343.8y
- May 26, 2030method-of-use (U-1522)US 86859343.8y
- Dec 16, 2029compositionUS 79195983.4y
- Dec 16, 2029compositionUS 79195983.4y
- Dec 16, 2029compositionUS 79195983.4y
- Dec 16, 2029compositionUS 79195983.4y
- Dec 16, 2029compositionUS 79195983.4y
- Dec 20, 2027patentUS 8501698*PED1.4y
- Dec 20, 2027patentUS 8501698*PED1.4y
- Dec 20, 2027patentUS 8501698*PED1.4y
- Dec 20, 2027patentUS 8501698*PED1.4y
- Dec 20, 2027patentUS 8501698*PED1.4y
- Jun 20, 2027formulationUS 8501698313d
- Jun 20, 2027formulationUS 8501698313d
- Jun 20, 2027formulationUS 8501698313d
- Jun 20, 2027formulationUS 8501698313d
- Jun 20, 2027formulationUS 8501698313d
- Apr 4, 2026patentUS 6515117*PED
- Apr 4, 2026patentUS 6515117*PED
- Apr 4, 2026patentUS 6515117*PED
- Apr 4, 2026patentUS 6515117*PED
- Apr 4, 2026patentUS 6515117*PED
- Oct 4, 2025compositionUS 6515117
- Oct 4, 2025compositionUS 6515117
- Oct 4, 2025compositionUS 6515117
- Oct 4, 2025compositionUS 6515117
- Oct 4, 2025compositionUS 6515117
FDA exclusivities (10)
- Dec 12, 2027PEDPediatric (6mo bonus)1.3y
- Dec 12, 2027PEDPediatric (6mo bonus)1.3y
- Dec 12, 2027PEDPediatric (6mo bonus)1.3y
- Dec 12, 2027PEDPediatric (6mo bonus)1.3y
- Dec 12, 2027PEDPediatric (6mo bonus)1.3y
- Jun 12, 2027NPPNew Product (3y)305d
- Jun 12, 2027NPPNew Product (3y)305d
- Jun 12, 2027NPPNew Product (3y)305d
- Jun 12, 2027NPPNew Product (3y)305d
- Jun 12, 2027NPPNew Product (3y)305d
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