Orange Book product · Brand (NDA)

PHYRAGO

DASATINIB

Brand (NDA)NDA 216099RX HANDA THERAP

View DASATINIB family Open on FDA Orange Book

At a glance

Dec 05, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 05, 2023
2 yr 7 mo ago
Today
Exclusivity ends · M-307
New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
Patent 11202778 expires
Listed method-of-use patent (U-3770) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11202778 expires
Listed method-of-use patent (U-3771) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11202778 expires
Listed method-of-use patent (U-3772) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11298356 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11324745 expires
Listed method-of-use patent (U-3767) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11324745 expires
Listed method-of-use patent (U-3768) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11324745 expires
Listed method-of-use patent (U-3769) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3769) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3768) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3767) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3770) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3771) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12433891 expires
Listed method-of-use patent (U-3772) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12465606 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3767) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3768) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3769) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3770) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3771) expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12544376 expires
Listed method-of-use patent (U-3772) expiration.
Jan 22, 2041
in 14 yr 10 mo

Pharmaceutical detail

Active ingredient

DASATINIB

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 216099

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11202778	Jan 22, 2041	in 14 yr 10 mo	U-3770
11202778	Jan 22, 2041	in 14 yr 10 mo	U-3771
11202778	Jan 22, 2041	in 14 yr 10 mo	U-3772
11298356	Jan 22, 2041	in 14 yr 10 mo	Product
11324745	Jan 22, 2041	in 14 yr 10 mo	U-3767
11324745	Jan 22, 2041	in 14 yr 10 mo	U-3768
11324745	Jan 22, 2041	in 14 yr 10 mo	U-3769
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3769
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3768
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3767
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3770
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3771
12433891	Jan 22, 2041	in 14 yr 10 mo	U-3772
12465606	Jan 22, 2041	in 14 yr 10 mo	Product
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3767
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3768
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3769
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3770
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3771
12544376	Jan 22, 2041	in 14 yr 10 mo	U-3772

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