Orange Book product · Brand (NDA)

RELEXXII

METHYLPHENIDATE HYDROCHLORIDE

Brand (NDA)NDA 216117RX OSMOTICA PHARM US

Jun 23, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 23, 2022
4 yr 1 mo ago
Today
Patent 10265308 expires
Listed drug product patent expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 10695336 expires
Listed method-of-use patent (U-4032) expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 9707217 expires
Listed drug product patent expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 9827234 expires
Listed method-of-use patent (U-4032) expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 9855258 expires
Listed drug product patent expiration.
Feb 03, 2037
in 10 yr 9 mo

Active ingredient

METHYLPHENIDATE HYDROCHLORIDE

Strength

18MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 216117

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10265308	Feb 03, 2037	in 10 yr 9 mo	ProductU-4032
10695336	Feb 03, 2037	in 10 yr 9 mo	U-4032
9707217	Feb 03, 2037	in 10 yr 9 mo	Product
9827234	Feb 03, 2037	in 10 yr 9 mo	U-4032
9855258	Feb 03, 2037	in 10 yr 9 mo	ProductU-4032