Regulatory Exclusivity: MISCELLANEOUS

Drugs with Miscellaneous Regulatory Exclusivity

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Applicant	Tradename	Generic Name	NDA	Approval Date	Type	Patent No.	Patent Expiration	Exclusivity Expiration	Patented / Exclusive Use
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	11,173,259*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	11,344,685*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	9,415,008*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	9,616,024*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	9,987,229*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	9,066,957*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	208799	Jul 12, 2019	DISCN	10,195,375*PED			REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST