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Details for New Drug Application (NDA): 204410

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NDA 204410 describes OPSUMIT, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the OPSUMIT profile page.

The generic ingredient in OPSUMIT is macitentan. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.

Summary for NDA: 204410

Tradename:
OPSUMIT
Applicant:
Actelion Pharms Ltd
Ingredient:
macitentan
Patents:4

Pharmacology for NDA: 204410

Suppliers and Packaging for NDA: 204410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPSUMIT
macitentan
TABLET;ORAL 204410 NDA Actelion Pharmaceuticals US, Inc. 66215-501 66215-501-15 1 BLISTER PACK in 1 CARTON (66215-501-15) > 15 TABLET, FILM COATED in 1 BLISTER PACK
OPSUMIT
macitentan
TABLET;ORAL 204410 NDA Actelion Pharmaceuticals US, Inc. 66215-501 66215-501-30 1 BOTTLE in 1 CARTON (66215-501-30) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Patent:7,094,781Patent Expiration:Oct 12, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:9,265,762Patent Expiration:May 29, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 3% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
Patent:8,367,685Patent Expiration:Oct 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION


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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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