Product profile · United States

CALQUENCE

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IngredientACALABRUTINIB MALEATE

Application typeNDA

Application216387

Product001

Dosage formTABLET

RouteORAL

StrengthEQ 100MG BASE

Approval date2022-08-03

Marketing statusPrescription

Status event—

ApplicantASTRAZENECA

Product source

Current GenericRadar decision

Year2035

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeDS_EQUIVALENT

Anchor date2035-01-21

Patent anchor2035-01-21

Exclusivity anchor—

Protection date2036-07-01

First Final ANDA—

Status event—

US10272083 claims 1 and 8 jointly cover CLL/SLL and MCL standard 100mg BID use; crystal-form tail remains through 2036-07-01.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7459554	2026-11-24	DS —	Y	N	TRUE_DS \| B1C03P8 issued-claim review2026-10-15: TRUE_DS	—	—	—
7459554	2026-11-24	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	—	—
10239883	2032-07-11	U U-2666	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10239883	2032-07-11	U U-2668	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10239883	2032-07-11	ORANGE_BOOK U-2666;U-2668	N	N	U English description not available.	—	—	—
9290504	2032-07-11	DS/DP —	Y	N	TRUE_DS \| B1C03P8 issued-claim review2026-10-15: TRUE_DS	—	—	—
9290504	2032-07-11	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	—	—
9758524	2032-07-11	U U-4108	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
9758524	2032-07-11	U U-2145	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
9758524	2032-07-11	ORANGE_BOOK U-2145;U-4108	N	N	U English description not available.	—	—	—
10272083	2035-01-21	U U-2683	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2684	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-4109	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2686	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2682	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2687	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2685	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	U U-2519	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10272083	2035-01-21	ORANGE_BOOK U-2519;U-2682;U-2683;U-2684;U-2685;U-2686;U-2687;U-4109	N	N	U English description not available.	—	—	—
11771696	2035-01-21	U U-3710	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11771696	2035-01-21	ORANGE_BOOK U-3710	N	N	U English description not available.	—	—	—
11166951	2035-08-11	U U-4428	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	U U-4430	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	U U-4429	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	U U-4426	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	U U-4427	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	U U-4431	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11166951	2035-08-11	ORANGE_BOOK U-4426;U-4427;U-4428;U-4429;U-4430;U-4431	N	N	U English description not available.	—	—	—
11059829	2036-07-01	DS/DP/U U-2145	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2666	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2670	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2669	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-4108	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2667	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2668	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	DS/DP/U U-2671	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11059829	2036-07-01	ORANGE_BOOK U-2145;U-2666;U-2667;U-2668;U-2669;U-2670;U-2671;U-4108	N	N	DP English description not available.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2017-10-31	2022-10-31	English description not available.	Y	Y	2022-10-31	OOPD_488915_ORIGINAL + OOPD_477415_ORIGINAL + I-960 Full coverage date: 2022-10-31	Source
OOPD_488915_ORIGINAL	2017-10-31	2024-10-31	English description not available.	N	N	—	OOPD_488915_ORIGINAL + OOPD_477415_ORIGINAL + I-960 Full coverage date: —	Source
OOPD_477415_ORIGINAL	2019-11-21	2026-11-21	English description not available.	N	N	—	OOPD_488915_ORIGINAL + OOPD_477415_ORIGINAL + I-960 Full coverage date: —	Source
I-960	2025-01-16	2028-01-16	English description not available.	N	N	—	—	Source
I-960	2025-01-16	2028-01-16	English description not available.	N	N	—	OOPD_488915_ORIGINAL + OOPD_477415_ORIGINAL + I-960 Full coverage date: —	Source
D-200	2026-02-19	2029-02-19	English description not available.	N	N	—	—	Source
D-200	2026-02-19	2029-02-19	English description not available.	N	N	—	OOPD_488915_ORIGINAL + OOPD_477415_ORIGINAL + I-960 Full coverage date: —	Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (1)

Type	Date	Role	Basis	Source
FINAL_REVIEW	—	ANCHOR_AND_TAIL	US10272083 claims 1 and 8 jointly cover CLL/SLL and MCL standard 100mg BID use; crystal-form tail remains through 2036-07-01.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2035	DEEP_REVIEW	FINAL	2035-01-21	2026-10-17 06:56:57
N	2032	DEEP_REVIEW	FINAL	2032-07-11	2026-10-15 03:06:32

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.