United Therapeutics Corporation

Registered sites: 4
Drug products: 40
Live patents: 105
Countries: 1
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging

Sites

Facilities

Site	Location	Operations	FEI
United Therapeutics Corporation	Beltsville, MDUnited States	Analytical testing, Finished drug manufacture	3013584633
United Therapeutics Corporation	Durham, NCUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003825766
United Therapeutics Corporation	Morrisville, NCUnited States	Analytical testing	3038472185
United Therapeutics Corporation	Silver Spring, MDUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture	3003368324

Exclusivity

Patents

105

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
ORENITRAM	TREPROSTINIL DIOLAMINE	Dec 2028
ORENITRAM	TREPROSTINIL DIOLAMINE	Feb 2030
ORENITRAM	TREPROSTINIL DIOLAMINE	Jan 2031
ORENITRAM	TREPROSTINIL DIOLAMINE	Aug 2031
REMODULIN	TREPROSTINIL	Sept 2028
REMODULIN	TREPROSTINIL	Dec 2028
REMODULIN	TREPROSTINIL	Mar 2029
TYVASO	TREPROSTINIL	May 2027
TYVASO	TREPROSTINIL	Mar 2028
TYVASO	TREPROSTINIL	May 2028
TYVASO	TREPROSTINIL	Dec 2028
TYVASO	TREPROSTINIL	Feb 2042
TYVASO DPI	TREPROSTINIL	May 2027
TYVASO DPI	TREPROSTINIL	Dec 2028
TYVASO DPI	TREPROSTINIL	Jun 2030
TYVASO DPI	TREPROSTINIL	Apr 2035
TYVASO DPI	TREPROSTINIL	Feb 2042

Catalogue

Marketed products

Showing 40 of 40.

Brand	Generic name	Form	Category
ADCIRCA	Tadalafil	TABLET	NDA
Alcohol-Free Hand Sanitizing Foam	BENZALKONIUM CHLORIDE	SOLUTION	OTC MONOGRAPH DRUG
BiteMD External Analgesic First Aid Antiseptic	Benzocaine, Camphor (Synthetic), and Phenol	LIQUID	OTC MONOGRAPH DRUG
Contact Instant Antiseptic Hand Sanitizer	Contact Instant Antiseptic Hand Sanitizer	LIQUID	OTC MONOGRAPH DRUG
Instant Antiseptic Hand Sanitizer	Alcohol	SOLUTION	OTC MONOGRAPH DRUG
Meringue Foaming Dye Free Antibacterial	Choroxylenol	LIQUID	OTC MONOGRAPH DRUG
Orenitram	treprostinil	TABLET, EXTENDED RELEASE	NDA
Orenitram	treprostinil	TABLET, EXTENDED RELEASE	NDA
Orenitram	treprostinil	TABLET, EXTENDED RELEASE	NDA
Orenitram	treprostinil	TABLET, EXTENDED RELEASE	NDA
Orenitram	treprostinil	TABLET, EXTENDED RELEASE	NDA
Orenitram	treprostinil	KIT	NDA
Orenitram	treprostinil	KIT	NDA
Orenitram	treprostinil	KIT	NDA
Remodulin	treprostinil	INJECTION, SOLUTION	NDA
Remodulin	treprostinil	INJECTION, SOLUTION	NDA
Remodulin	treprostinil	INJECTION, SOLUTION	NDA
Remodulin	treprostinil	INJECTION, SOLUTION	NDA
Remodulin	treprostinil	INJECTION, SOLUTION	NDA
Sterile Diluent for Remodulin	water	INJECTION, SOLUTION	NDA
TYVASO	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	KIT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Tyvaso DPI	treprostinil	INHALANT	NDA
Unituxin	DINUTUXIMAB	INJECTION	BLA

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.