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Details for New Drug Application (NDA): 021272

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NDA 021272 describes REMODULIN, which is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the REMODULIN profile page.

The generic ingredient in REMODULIN is treprostinil. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the treprostinil profile page.

Summary for NDA: 021272

Tradename:
REMODULIN
Applicant:
United Therap
Ingredient:
treprostinil
Patents:6

Pharmacology for NDA: 021272

Ingredient-typeProstaglandins I
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 021272

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272 NDA United Therapeutics Corporation 66302-101 66302-101-01 1 VIAL in 1 BOX (66302-101-01) > 20 mL in 1 VIAL
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272 NDA United Therapeutics Corporation 66302-102 66302-102-01 1 VIAL in 1 BOX (66302-102-01) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION), SUBCUTANEOUSStrength1MG/ML
Approval Date:May 21, 2002TE:RLD:No
Patent:6,765,117Patent Expiration:Oct 24, 2017Product Flag?Substance Flag?YDelist Request?
Patent:8,497,393Patent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?
Patent:7,999,007Patent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

Expired Orange Book Patents for NDA: 021272

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 20025,153,222► subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 20025,153,222► subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 20025,153,222► subscribe
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