Orange Book product · Brand (NDA)

MORPHINE SULFATE

Brand (NDA)NDA 204223RX FRESENIUS KABI USA

Oct 30, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 30, 2013
12 yr 10 mo ago
Today
Patent 9072781 expires
Listed drug product patent expiration.
Mar 12, 2034
in 7 yr 10 mo
Patent 9192608 expires
Listed method-of-use patent (U-43) expiration.
Mar 12, 2034
in 7 yr 10 mo
Patent 9192608 expires
Listed method-of-use patent (U-55) expiration.
Mar 12, 2034
in 7 yr 10 mo
Patent 9248229 expires
Listed drug product patent expiration.
Mar 12, 2034
in 7 yr 10 mo

Active ingredient

MORPHINE SULFATE

Strength

2MG/ML (2MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS

TE code

Not listed

Application

NDA 204223

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
9072781	Mar 12, 2034	in 7 yr 10 mo	Product
9192608	Mar 12, 2034	in 7 yr 10 mo	U-43
9192608	Mar 12, 2034	in 7 yr 10 mo	U-55
9248229	Mar 12, 2034	in 7 yr 10 mo	Product