Xigduo XR

Xigduo XR · pharmadog

Patent cliff

source: FDA Orange Book

first barrier falls

Jun 12, 2027

324 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*PED3.9y
Jun 16, 2030patentUS 7919598*PED3.9y
Jun 16, 2030patentUS 7919598*PED3.9y
Jun 16, 2030patentUS 7919598*PED3.9y
Jun 16, 2030patentUS 7919598*PED3.9y
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 8501698332d
Jun 20, 2027formulationUS 8501698332d
Jun 20, 2027formulationUS 8501698332d
Jun 20, 2027formulationUS 8501698332d
Jun 20, 2027formulationUS 8501698332d
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)1.4y
Dec 12, 2027PEDPediatric (6mo bonus)1.4y
Dec 12, 2027PEDPediatric (6mo bonus)1.4y
Dec 12, 2027PEDPediatric (6mo bonus)1.4y
Dec 12, 2027PEDPediatric (6mo bonus)1.4y
Jun 12, 2027NPPNew Product (3y)324d

(dapagliflozin + metformin hydrochloride) ER

indications

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Patent cliff

patents (50)

FDA exclusivities (10)

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Trials studying (dapagliflozin + metformin hydrochloride) ER