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Your search for “patent exclusivity” returned the following results.
…destined for passage. However, it stalled over differences in the House and Senate bills on the proposed length of time for marketing exclusivity afforded for certain innovations. That issue was…
…order FDA to decide whether to pull generic drug marketing exclusivity from Ranbaxy for its serious data integrity and other manufacturing violations, a request that was denied. Mylan Pharms. v….
…[FDA] will need to determine if the designation and/or marketing exclusivity should remain in place or whether the designation and/or exclusivity should be revoked as permitted under 21 CFR 316.29.” …
…FDA did not grant Sanofi a period of 3-year new clinical investigation marketing exclusivity for the prescription-to-OTC switch of NASACORT. So some might say that the company’s efforts to prevent…
…(e.g, exclusivity) and help ensure that the regulatory framework is both sufficiently flexible and adequately protects public safety. FDA plans to schedule a meeting with industry this spring. Creation of…
…intent of sharing the combined trial data to support separate BLAs from each of the individual centers/institutions could be considered the “same drug” for purposes of orphan-drug designation and exclusivity….
…will dive straight into patent or exclusivity challenges, so any additional market entrants are more likely to be superfluous follow-on generics, which may not have much of an effect on…
…for the introduction of new OTC products that are marketed without an approved New Drug Application. Under certain circumstances, such drugs would be subject to two-year exclusivity period. The bill…
…qualify for 5-year new chemical entity exclusivity under the FDC Act or 12-year reference product exclusivity under the PHS Act.) As mentioned above, the term “innovative treatment” is a defined…
…potential scope of 3-year new clinical studies exclusivity if holders of approved midodrine applications were to collaboratively or individually complete the required post-marketing studies to verify clinical benefit for midodrine…
…exclusivity. To be eligible for this exclusivity, the approved drug must have been designated as an orphan drug by FDA. The ODA provides two routes for obtaining designation of a…
…Excluded from the new law are petitions that relate “solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv)” (i.e., 180-day exclusivity), and petitions that are…
…reference product is licensed” (emphasis in original), and notwithstanding that a biosimilar/interchangeable biological product may not be licensed for all reference product uses (i.e., is “skinny labeled”) because of patent…
…in the price of an “essential off-patent or generic drug.” HB 631 defines an “unconscionable increase” as “an increase in the price of a prescription drug that: (1) is excessive…
…(“BPCIA”) patent dance has been resolved. But that would be too easy. Even though U.S. Supreme Court was needed to determine that the BPCIA requires aBLA sponsors to provide notice…