| Applicant | Tradename | Generic Name | NDA | Approval Date | Exclusivity Expiration | Patented / Exclusive Use | | Astellas | LEXISCAN | regadenoson | 022161 | Apr 10, 2008 | Apr 10, 2013 | NEW CHEMICAL ENTITY | | Ovation Pharms | NEOPROFEN | ibuprofen lysine | 021903 | Apr 13, 2006 | Apr 13, 2013 | ORPHAN DRUG EXCLUSIVITY | | Progenics | RELISTOR | methylnaltrexone bromide | 021964 | Apr 24, 2008 | Apr 24, 2013 | NEW CHEMICAL ENTITY | | Prestwick | XENAZINE | tetrabenazine | 021894 | Aug 15, 2008 | Aug 15, 2013 | NEW CHEMICAL ENTITY | | Merck Sante Sas | CYANOKIT | hydroxocobalamin | 022041 | Dec 15, 2006 | Dec 15, 2013 | ORPHAN DRUG EXCLUSIVITY |
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