Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Medtronic
Fuji
Colorcon
UBS
QuintilesIMS
Fish and Richardson
Julphar

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204410

« Back to Dashboard

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 and one Paragraph IV challenge. Additional details are available on the OPSUMIT profile page.

The generic ingredient in OPSUMIT is macitentan. There are ten 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 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 N 66215-501-15
OPSUMIT macitentan TABLET;ORAL 204410 NDA Actelion Pharmaceuticals US, Inc. 66215-501 N 66215-501-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 18, 2020
Regulatory Exclusivity Use:TX OF PAH TO DELAY DISEASE PROGRESSION.DISEASE PROGRESSION INCLUDED:DEATH, INITIATION OF IV OR SC PROSTANOIDS, OR CLINICAL WORSENING OF PAH (DECREASED 6-MINUTE WALK DISTANCE, WORSENED PAH SYMPTOMS AND NEED FOR ADDITIONAL PAH TREATMENT).
Patent:➤ Try a Free TrialPatent Expiration:Oct 12, 2022Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cerilliant
Chinese Patent Office
Mallinckrodt
Johnson and Johnson
Fuji
Dow
Merck
AstraZeneca

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.