Requirements, Benefits, and Possible Consequences of …
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IntroductionPatent Information For Listing Benefits of Listing Having a patent listed in the Orange Book provides significant benefits to the NDA holder. Companies seeking to market a generic version of a drug must certify as to each patent claiming the drug or a use of the drug for which the applicant seeks approval that (1) the NDA holder has not submitted patent information to the FDA fo...
Benefits of Listing Having a patent listed in the Orange Book provides significant benefits to the NDA holder. Companies seeking to market a generic version of a drug must certify as to each patent claiming the drug or a use of the drug for which the applicant seeks approval that (1) the NDA holder has not submitted patent information to the FDA fo...
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