Orexo AB Receives Paragraph IV Notice Letter Concerning Abstral® In The U.S.

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo AB (STO:ORX), today announced that it has, together with its partner Galena Biopharma, Inc. (“Galena”), received a “Paragraph IV” patent certification notice from Actavis Laboratories FL, Inc. (“Actavis”). The Notice Letter advice Orexo of Actavis’s filing of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration seeking approval of generic versions of Abstral® (fentanyl) sublingual tablets prior to the expiration of Orexo’s patents listed in the Orange Book. Galena currently markets Abstral® (fentanyl) sublingual tablets and is the owner of the New Drug Application in the United States.

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