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See the DrugPatentWatch profile for Rexulti
Rexulti Patent Exclusivity Timeline Rexulti (brexiprazine) is an antipsychotic medication used to treat schizophrenia and major depressive disorder. Developed by Otsuka Pharmaceutical and H. Lundbeck A/S, Rexulti was first approved by the FDA in 2015. According to DrugPatentWatch.com [1], the Rexulti patent, US7868215, held by Otsuka Pharmaceutical, is set to expire on April 28, 2027. When Does Exclusivity Expire? As mentioned earlier, Rexulti's US patent expires in 2027, but this does not necessarily mean generic versions will be available immediately. According to FDA regulations, an exclusivity period of 180 days (approximately six months) may apply after the patent expires, during which the first generic applicant will have market exclusivity. This means that generic versions may enter the market in October 2027, at the earliest. Why Is Otsuka Pharmaceutical Challenging the Patent? Otsuka Pharmaceutical, the manufacturer of Rexulti, is likely seeking to extend the patent exclusivity period or negotiate a market approval period for their generic counterpart, in accordance with the patent and exclusivity laws [2]. Who Makes Generic Versions of Rexulti? Several companies, including Mylan, Lupin, and Torrent Pharmaceuticals, have filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Rexulti, citing US patents [1] held by Otsuka Pharmaceutical. These companies will likely be the first to market generic versions after the exclusivity period expires or is lifted. What Side Effects Are Patients Asking About? As the patent expiry approaches, the availability of generic versions may be of significant interest to patients. While patients may be concerned about the cost reduction and potential accessibility of Rexulti, it is essential to consult a healthcare professional to discuss treatment options, as generic versions may require different dosing regimens or have varying side effects [3]. Sources: [1] DrugPatentWatch.com - Patent US7868215 [2] Otsuka Pharmaceutical: Rexulti (brexiprazine) - FDA Approval [3] Rexulti (brexiprazine) - FDA Label Information.
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