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These entry\nbarriers take the form of patents that protect intellectual property and marketing exclusivity\nprovisions that are provided by statute. This review focuses on the basic ins and outs of\nregulatory and patent exclusivities for which new chemical entities (NCEs), referring to\nnever-before approved drugs with an entirely new active ingredient, are eligible and uses\nRRx-001, a small molecule aerospace-derived NCE in development for the treatment of\ncancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3\n(NLRP3) inflammasome, as a \u201creal world\u201d example. This is intended as a \u2018101-type\u2019 of\nprimer; its aim is to help developers of original pharmaceuticals navigate the maze of\npatents, other IP regulations, and statutory exclusivities in major markets so that they can\nmake proper use of them.<\/jats:p>\n<\/jats:sec>","DOI":"10.2174\/1872208317666230111105223","type":"journal-article","created":{"date-parts":[[2023,1,13]],"date-time":"2023-01-13T06:16:45Z","timestamp":1673590605000},"page":"257-270","update-policy":"https:\/\/doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Patent and Marketing Exclusivities 101 for Drug Developers"],"prefix":"10.2174","volume":"17","author":[{"given":"Bryan","family":"Oronsky","sequence":"first","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Caroen","sequence":"additional","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Brinkhaus","sequence":"additional","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Reid","sequence":"additional","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meaghan","family":"Stirn","sequence":"additional","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raj","family":"Kumar","sequence":"additional","affiliation":[{"name":"EpicentRx, Torrey Pines, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"965","reference":[{"key":"ref=1","doi-asserted-by":"publisher","first-page":"219","DOI":"10.15430\/JCP.2021.26.4.219","volume":"26","author":"Surh Y.J.","year":"2021","unstructured":"Surh Y.J.; The 50-year war on cancer revisited: Should we continue to fight the enemy within? 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