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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	eculizumab
Trade Name:	Soliris
Date Designated:	06/12/2014
Orphan Designation:	Treatment of Myasthenia Gravis
Orphan Designation Status:	Designated/Approved
Sponsor:	Alexion Pharmaceuticals, Inc. 121 Seaport Boulevard Boston, Massachusetts 02210 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	eculizumab
	Trade Name:	Soliris
	Marketing Approval Date:	10/23/2017
	Approved Labeled Indication:	for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
	Exclusivity End Date:	10/23/2024
	Exclusivity Protected Indication* :	for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

2	Generic Name:	ravulizumab-cwvz
	Trade Name:	Ultomiris
	Marketing Approval Date:	04/27/2022
	Approved Labeled Indication:	Treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive
	Exclusivity End Date:	TBD

3	Generic Name:	eculizumab
	Trade Name:	Soliris
	Marketing Approval Date:	02/28/2025
	Approved Labeled Indication:	treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive
	Exclusivity End Date:	02/28/2032
	Exclusivity Protected Indication* :	treatment of generalized myasthenia gravis (gMG) in pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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