Is Collegium Pharmaceutical, Inc. FDA approved?

Collegium Pharmaceutical, 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 Collegium Pharmaceutical, Inc. make?

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

Collegium Pharmaceutical, 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: 60
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
capsule, extended release	5
tablet, film coated, extended release	5
tablet, film coated	3

Route	NDCs
oral	13

Labeller name on the listing	NDCs
collegium pharmaceutical, inc.	13

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11344512	NUCYNTA ERtapentadol hydrochloride	use	Apr 2028
8536130	NUCYNTA ERtapentadol hydrochloride	use	Sept 2028
7771707	XTAMPZA ERoxycodone	product	Oct 2028
11344512*PED	NUCYNTA ERtapentadol hydrochloride	use	Oct 2028
8536130*PED	NUCYNTA ERtapentadol hydrochloride	use	Mar 2029
10004729	XTAMPZA ERoxycodone	product	Dec 2030
10668060	XTAMPZA ERoxycodone	product	Dec 2030
9682075	XTAMPZA ERoxycodone	product	Dec 2030
10188644	XTAMPZA ERoxycodone	product	Sept 2036
10646485	XTAMPZA ERoxycodone	product	Sept 2036
9737530	XTAMPZA ERoxycodone	product	Sept 2036
9968598	XTAMPZA ERoxycodone	product	Sept 2036

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Nucynta	tapentadol hydrochloride	tablet, film coated, oral	24510-050NDA
Nucynta	tapentadol hydrochloride	tablet, film coated, oral	24510-075NDA
Nucynta	tapentadol hydrochloride	tablet, film coated, oral	24510-100NDA
Nucynta ER	tapentadol hydrochloride	tablet, film coated, extended release, oral	24510-058NDA
Nucynta ER	tapentadol hydrochloride	tablet, film coated, extended release, oral	24510-116NDA
Nucynta ER	tapentadol hydrochloride	tablet, film coated, extended release, oral	24510-174NDA
Nucynta ER	tapentadol hydrochloride	tablet, film coated, extended release, oral	24510-232NDA
Nucynta ER	tapentadol hydrochloride	tablet, film coated, extended release, oral	24510-291NDA
XTAMPZA ER	OXYCODONE	capsule, extended release, oral	24510-110NDA
XTAMPZA ER	OXYCODONE	capsule, extended release, oral	24510-115NDA
XTAMPZA ER	OXYCODONE	capsule, extended release, oral	24510-120NDA
XTAMPZA ER	OXYCODONE	capsule, extended release, oral	24510-130NDA
XTAMPZA ER	OXYCODONE	capsule, extended release, oral	24510-140NDA

Enquiry

Common questions

Is Collegium Pharmaceutical, Inc. FDA approved?: Collegium Pharmaceutical, 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 Collegium Pharmaceutical, Inc. make?: 13 products are listed under Collegium Pharmaceutical, Inc. in the openFDA NDC Directory, most often as capsule, extended release; tablet, film coated, extended release; tablet, film coated. 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.