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Last Updated: June 3, 2023

Regulatory Exclusivity: PEDIATRIC EXCLUSIVITY

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Drugs with Pediatric Exclusivity Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012		RX	Yes	No	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	AB	RX	Yes	No	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	AB	RX	Yes	Yes	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No	⤷ Try a Trial	PEDIATRIC EXCLUSIVITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

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Harvard Business School

Moodys

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