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Regulatory Exclusivity Expiring in 2007

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Exclusivity Expiration Patented / Exclusive Use
Glaxo Wellcome
FLOLAN
epoprostenol sodium
Injectable; Injection020444-002SEP 20, 1995RXYes<disabled>ORPHAN DRUG EXCLUSIVITY
Glaxo Wellcome
FLOLAN
epoprostenol sodium
Injectable; Injection020444-001SEP 20, 1995RXYes<disabled>ORPHAN DRUG EXCLUSIVITY
Wyeth Ayerst
MYLOTARG
gemtuzumab ozogamicin
Injectable; Injection021174-001MAY 17, 2000RXYes<disabled>ORPHAN DRUG EXCLUSIVITY
Serono
GONAL-F
follitropin alfa/beta
Injectable; Injection020378-003MAY 25, 2000RXNo<disabled>ORPHAN DRUG EXCLUSIVITY
Serono
GONAL-F
follitropin alfa/beta
Injectable; Injection020378-002SEP 29, 1997RXNo<disabled>ORPHAN DRUG EXCLUSIVITY
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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