| Applicant | Tradename | Generic Name | NDA | Approval Date | Exclusivity Expiration | Patented / Exclusive Use | | Beaufour Ipsen | SOMATULINE DEPOT | lanreotide acetate | 022074 | Aug 30, 2007 | Aug 30, 2014 | ORPHAN DRUG EXCLUSIVITY | | Biomarin Pharm | KUVAN | sapropterin dihydrochloride | 022181 | Dec 13, 2007 | Dec 13, 2014 | ORPHAN DRUG EXCLUSIVITY | | Genzyme | THYROGEN | thyrotropin alfa | 020898 | Nov 30, 1998 | Dec 14, 2014 | ORPHAN DRUG EXCLUSIVITY | | Gilead | LETAIRIS | ambrisentan | 022081 | Jun 15, 2007 | Jun 15, 2014 | ORPHAN DRUG EXCLUSIVITY | | Salix Pharms | COLAZAL | balsalazide disodium | 020610 | Jul 18, 2000 | Jun 20, 2014 | PEDIATRIC EXCLUSIVITY |
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