Is PTC Therapeutics, Inc. FDA approved?

PTC Therapeutics, Inc. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does PTC Therapeutics, Inc. make?

8 products are listed under PTC Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet; powder; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

PTC Therapeutics, Inc.

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

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Registered sites: 0
Active NDC listings: 8
Labeller names: 2
Live patents: 8
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: NDA 7, BLA 1.

Dosage form	NDCs
tablet	4
powder	2
suspension	2

Route	NDCs
oral	7
intracerebral	1

Labeller name on the listing	NDCs
ptc therapeutics, inc.	6
ptc therapeutics inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11072614	SEPHIENCEsepiapterin	substance	Apr 2038
11752154	SEPHIENCEsepiapterin	product	Sept 2038
12213982	SEPHIENCEsepiapterin	use	Sept 2038
12257252	SEPHIENCEsepiapterin	use	Mar 2042

Product	Exclusivity	Until
SEPHIENCESEPIAPTERIN	ODE-542 Orphan drug	Jul 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
EMFLAZA	deflazacort	tablet, oral	52856-501NDA
EMFLAZA	deflazacort	tablet, oral	52856-502NDA
EMFLAZA	deflazacort	tablet, oral	52856-503NDA
EMFLAZA	deflazacort	tablet, oral	52856-504NDA
EMFLAZA	deflazacort	suspension, oral	52856-505NDA
KEBILIDI	eladocagene exuparvovec-tneq	suspension, intracerebral	52856-601BLA
Sephience	sepiapterin	powder, oral	52856-201NDA
Sephience	sepiapterin	powder, oral	52856-301NDA

Compare

Other companies listing deflazacort

Aucta Pharmaceuticals, Inc.2 sites · 8 NDC
Amneal Pharmaceuticals NY LLC0 sites · 337 NDC

Enquiry

Common questions

Is PTC Therapeutics, Inc. FDA approved?: PTC Therapeutics, Inc. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does PTC Therapeutics, Inc. make?: 8 products are listed under PTC Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet; powder; suspension. 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.