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acalabrutinib · Astrazeneca · NDA 210259, 216387

Calquence

Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Jul 2036

Blocked by patent: US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 10167291, US 11059829, US 11059829, US 11059829, US 11059829, US 11059829, US 11059829, US 11059829, US 11059829, US 9796721, US 9796721, US 9796721, US 9796721, US 9796721, US 9796721, US 9796721, US 9796721.

Listed patents · 52 unexpired

PatentClaimsExpires
US 10167291product, use U-26831 Jul 2036
US 10167291product, use U-26821 Jul 2036
US 10167291product, use U-26851 Jul 2036
US 10167291product, use U-26841 Jul 2036
US 10167291product, use U-21451 Jul 2036
US 10167291product, use U-26671 Jul 2036
US 10167291product, use U-26701 Jul 2036
US 10167291product, use U-26661 Jul 2036
US 10167291product, use U-26681 Jul 2036
US 10167291product, use U-26691 Jul 2036
US 10167291product, use U-26861 Jul 2036
US 10167291product, use U-26871 Jul 2036
US 10167291product, use U-25191 Jul 2036
US 10167291product, use U-41091 Jul 2036
US 10167291product, use U-26711 Jul 2036
US 11059829substance, product, use U-41081 Jul 2036
US 11059829substance, product, use U-26701 Jul 2036
US 11059829substance, product, use U-26711 Jul 2036
US 11059829substance, product, use U-21451 Jul 2036
US 11059829substance, product, use U-26661 Jul 2036
US 11059829substance, product, use U-26671 Jul 2036
US 11059829substance, product, use U-26681 Jul 2036
US 11059829substance, product, use U-26691 Jul 2036
US 9796721substance, product, use U-21451 Jul 2036
US 9796721substance, product, use U-26691 Jul 2036
US 9796721substance, product, use U-26711 Jul 2036
US 9796721substance, product, use U-26701 Jul 2036
US 9796721substance, product, use U-26681 Jul 2036
US 9796721substance, product, use U-26661 Jul 2036
US 9796721substance, product, use U-26671 Jul 2036
US 9796721substance, product, use U-41081 Jul 2036
US 11166951use U-442711 Aug 2035
US 11166951use U-442611 Aug 2035
US 11166951use U-443011 Aug 2035
US 11166951use U-442911 Aug 2035
US 11166951use U-443111 Aug 2035
US 11166951use U-442811 Aug 2035
US 10272083use U-268321 Jan 2035
US 10272083use U-410921 Jan 2035
US 10272083use U-268521 Jan 2035
US 10272083use U-268221 Jan 2035
US 10272083use U-268721 Jan 2035
US 10272083use U-268421 Jan 2035
US 10272083use U-268621 Jan 2035
US 10272083use U-251921 Jan 2035
US 11771696use U-371021 Jan 2035
US 10239883use U-266611 Jul 2032
US 10239883use U-266811 Jul 2032
US 9290504substance, product11 Jul 2032
US 9758524use U-214511 Jul 2032
US 9758524use U-410811 Jul 2032
US 7459554substance24 Nov 2026

Exclusivities · 3 unexpired

D-200new dosing schedule19 Feb 2029
I-960new indication (3 years)16 Jan 2028
ODE-274orphan drug (7 years)21 Nov 2026

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 24 Oct 2026Exclusivity expires within 90 days ODE-274 · 210259-001

Products covered · 2

NDA · productFormStrengthListed expiry
210259 · 001 · RLDcapsule, oral100MG1 Jul 2036
216387 · 001 · RLDtablet, oralEQ 100MG BASE1 Jul 2036