Details for Patent: 12,016,861

Which drugs does patent 12,016,861 protect, and when does it expire?

Patent 12,016,861 protects CAVHANZA and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 12,016,861

Title:	Amorphous nilotinib microparticles and uses thereof
Abstract:	Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor nilotinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer. In some embodiments, the pharmaceutical compositions can be administered without regard to food consumption. In other embodiments, the pharmaceutical compositions can be administered at a significantly lower dose as compared to a commercially available immediate-release nilotinib formulation, while providing a comparable therapeutic effect.
Inventor(s):	Christian F. Wertz, Tzehaw Chen, Joseph McTarsney
Assignee:	Flex Pharma LLC
Application Number:	US18/089,338
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Dosage form;

Drugs Protected by US Patent 12,016,861

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379-001	May 29, 2026		RX	Yes	No	12,016,861					USE OF 120 MG NILOTINIB TWICE DAILY FOR TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PH+ CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379-001	May 29, 2026		RX	Yes	No	12,016,861					USE OF 160 MG NILOTINIB TWICE DAILY FOR TREATMENT OF ADULT PATIENTS WITH CHRONIC PHASE AND ACCELERATED PHASE PH+ CHRONIC MYELOID LEUKEMIA RESISTANT TO OR INTOLERANT TO PRIOR THERAPY THAT INCLUDED IMATINIB
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379-002	May 29, 2026		RX	Yes	Yes	12,016,861					USE OF 120 MG NILOTINIB TWICE DAILY FOR TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PH+ CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379-002	May 29, 2026		RX	Yes	Yes	12,016,861					USE OF 160 MG NILOTINIB TWICE DAILY FOR TREATMENT OF ADULT PATIENTS WITH CHRONIC PHASE AND ACCELERATED PHASE PH+ CHRONIC MYELOID LEUKEMIA RESISTANT TO OR INTOLERANT TO PRIOR THERAPY THAT INCLUDED IMATINIB

International Family Members for US Patent 12,016,861

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021212258
Australia	2026204369
Canada	3168680
Canada	3313023
European Patent Office	4096791
Israel	295007