Is NextWave Pharmaceuticals, Inc FDA approved?

NextWave Pharmaceuticals, Inc holds no registered establishment of its own; 13 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does NextWave Pharmaceuticals, Inc make?

13 products are listed under NextWave Pharmaceuticals, Inc in the openFDA NDC Directory, most often as suspension, extended release; tablet, extended release; tablet, chewable, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

NextWave Pharmaceuticals, Inc

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 13
Live patents: 37
Countries: 0

Catalogue

Drug listings by form and route

13 active NDC listings: 13 human prescription drug. By marketing category: NDA 13.

Dosage form	NDCs
suspension, extended release	6
tablet, extended release	4
tablet, chewable, extended release	3

Route	NDCs
oral	13

Labeller name on the listing	NDCs
nextwave pharmaceuticals, inc	13

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8202537	QUILLICHEW ERmethylphenidate hydrochloride	product	Mar 2027
8062667	QUILLIVANT XRmethylphenidate hydrochloride	product	Mar 2029
8287903	QUILLICHEW ER, QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
8465765	QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
8563033	QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
8778390	QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
8956649	QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
9040083	QUILLIVANT XRmethylphenidate hydrochloride	product	Feb 2031
10857143	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
11103494	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
11103495	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
11633389	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
8999386	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
9295642	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
9545399	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033
9844544	QUILLICHEW ERmethylphenidate hydrochloride	product	Aug 2033

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
DYANAVEL XR	amphetamine	tablet, extended release, oral	24478-106NDA
DYANAVEL XR	amphetamine	tablet, extended release, oral	24478-108NDA
DYANAVEL XR	amphetamine	tablet, extended release, oral	24478-109NDA
DYANAVEL XR	amphetamine	tablet, extended release, oral	24478-110NDA
Dyanavel XR	amphetamine	suspension, extended release, oral	24478-102NDA
ONYDA XR	Clonidine hydrochloride	suspension, extended release, oral	24478-148NDA
QuilliChew ER	methylphenidate hydrochloride	tablet, chewable, extended release, oral	24478-074NDA
QuilliChew ER	methylphenidate hydrochloride	tablet, chewable, extended release, oral	24478-075NDA
QuilliChew ER	methylphenidate hydrochloride	tablet, chewable, extended release, oral	24478-076NDA
Quillivant XR	methylphenidate hydrochloride	suspension, extended release, oral	24478-321NDA
Quillivant XR	methylphenidate hydrochloride	suspension, extended release, oral	24478-322NDA
Quillivant XR	methylphenidate hydrochloride	suspension, extended release, oral	24478-323NDA
Quillivant XR	methylphenidate hydrochloride	suspension, extended release, oral	24478-324NDA

Compare

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Vertical Pharmaceuticals, LLC0 sites · 15 NDC
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Enquiry

Common questions

Is NextWave Pharmaceuticals, Inc FDA approved?: NextWave Pharmaceuticals, Inc holds no registered establishment of its own; 13 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does NextWave Pharmaceuticals, Inc make?: 13 products are listed under NextWave Pharmaceuticals, Inc in the openFDA NDC Directory, most often as suspension, extended release; tablet, extended release; tablet, chewable, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.