Table 2. Orange Book and USPTO Non-Inclusion Criteria Summary and Examples.

Orange Book Non-Inclusion Criteria and Examples
Exclusion Criteria	NCD Medicine	Reason
No patent/exclusivity info	Carboplatin	23 drug applications, none with unexpired patent/exclusivity
Different administration/dosage from MLEM	Fluorouracil	Carac (PN) identified but with route of administration as topical cream not covered in MLEM
Classified as Therapeutic Equivalence	Gilbernclamide (USAN: Glyburide)	Glucovance (PN) had patent/exclusivity data, but further examination determined TE classification and patent associated with combination uses
Did not make active drug substance claim	Isosorbide Dinitrate	Bidil (PN) listed as RLD, but remaining patents not associated with active drug substance
USPTO Exclusion Criteria and Examples
Combination product of 1 active substance	Amlodipine	Cadut (PN) identified but combination therapy of amlodipine and atorvastatin
Method patent to manufacture/process drug	Cytarabine	Depocyt (PN) had patent/exclusivity data, but further examination determined method patent for treatment
Patents for other delivery devices	Nicotine Replacement Therapy	Nicorette and Committ (PN) identified with patent/exclusivity data, but further examination showed different delivery device then MLEM-indicated (e.g. trilaminate film and troche/lozenge)