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Serving 500+ biopharmaceutical companies globally:

Merck
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Fuji
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Generated: September 24, 2017

DrugPatentWatch Database Preview

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 nine 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 fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for NDA: 021272

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:9

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:Yes
Patent:► SubscribePatent Expiration:Oct 24, 2017Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent 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
Patent:► SubscribePatent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?

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, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

UBS
Merck
Cipla
Baxter
US Department of Justice
Harvard Business School
Medtronic
Cerilliant
Federal Trade Commission
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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