Editing Celecoxib (section)

==History==
{{See also|Discovery and development of cyclooxygenase 2 inhibitors}}

It was initially marketed by [[Pfizer]] for arthritis. Celecoxib and other COX-2 selective inhibitors, [[valdecoxib]], [[parecoxib]], and [[mavacoxib]], were discovered by a team at the [[G.D. Searle, LLC|Searle]] division of [[Monsanto]] led by [[John Talley (chemist)|John Talley]].<ref name=Forbes2003>{{cite news| vauthors = Langreth R |title=The Chemical Cobbler|url=https://www.forbes.com/global/2003/0623/050.html|work=Forbes|date=23 June 2003|access-date=15 April 2018|archive-date=16 April 2018|archive-url=https://web.archive.org/web/20180416013759/https://www.forbes.com/global/2003/0623/050.html|url-status=live}}</ref><ref name=SLACS>{{cite journal|title=Dr. John Talley: 2001 St. Louis Awardee|journal=Chemical Bond|date=May 2001|volume=52|issue=5|page=2|url=http://www.stlacs.org/Bonds/2001May.pdf|archive-url=https://web.archive.org/web/20180415180802/http://www.stlacs.org/Bonds/2001May.pdf|archive-date=15 April 2018}}</ref>

Two lawsuits arose over the discovery of celecoxib. Daniel L. Simmons of [[Brigham Young University]] (BYU) discovered the COX-2 enzyme in 1988,<ref name="ScientistBYULitig">{{cite web | url = http://www.the-scientist.com/news/display/25408/ | title = University sues Pfizer over COX-2 research | author = Yajnik J | date = 27 October 2006 | work = [[The Scientist (magazine)|The Scientist]] | access-date = 11 November 2010 | archive-date = 3 February 2009 | archive-url = https://web.archive.org/web/20090203140727/http://www.the-scientist.com/news/display/25408/ | url-status = dead }}</ref> and in 1991, BYU entered into a collaboration with [[Monsanto]] to develop drugs to inhibit it. Monsanto's pharmaceutical division was later purchased by [[Pfizer]], and in 2006, BYU sued Pfizer for breach of contract, claiming Pfizer did not properly pay contractual royalties back to BYU.<ref name="Deseret News">{{cite web |work=Deseret News |date=28 October 2009 |url=http://www.deseretnews.com/article/705340277/Judge-orders-Pfizer-to-pay-BYU-852K-for-suit-delays.html |title=Judge orders Pfizer to pay BYU $852K for suit delays |author=Linda Thomson |access-date=23 November 2009 |archive-date=31 October 2009 |archive-url=https://web.archive.org/web/20091031124503/http://www.deseretnews.com/article/705340277/Judge-orders-Pfizer-to-pay-BYU-852K-for-suit-delays.html |url-status=dead }}</ref> A settlement was reached in April 2012, in which Pfizer agreed to pay $450 million.<ref name="Settlement">{{cite news | vauthors = Harvey T |title=Pfizer, BYU settle Celebrex lawsuit for $450M |work=[[The Salt Lake Tribune]] |date=1 May 2012 |url=http://www.sltrib.com/sltrib/entertainment/54024947-79/byu-pfizer-settlement-simmons.html.csp |access-date=22 July 2012 |archive-date=3 March 2016 |archive-url= https://web.archive.org/web/20160303220047/http://www.sltrib.com/sltrib/entertainment/54024947-79/byu-pfizer-settlement-simmons.html.csp |url-status=live }}</ref><ref>{{cite news | title=Pfizer Settles B.Y.U. Lawsuit Over Development of Celebrex | website=[[The New York Times]] | date=1 May 2012 | url=https://www.nytimes.com/2012/05/02/health/pfizer-settles-byu-lawsuit-over-development-of-celebrex.html | agency=[[Associated Press]] | access-date=5 May 2020 | archive-date=27 December 2017 | archive-url=https://web.archive.org/web/20171227132546/http://www.nytimes.com/2012/05/02/health/pfizer-settles-byu-lawsuit-over-development-of-celebrex.html | url-status=live }}</ref> Other important discoveries in COX-2 were made at [[University of Rochester]], which patented the discoveries.<ref>{{US patent | 6048850}}</ref> When the patent was issued, the university sued Searle (later Pfizer) in a case called, ''University of Rochester v. G.D. Searle & Co.'', 358 F.3d 916 (Fed. Cir. 2004). The court ruled in favor of Searle in 2004, holding in essence that the university had claimed a method requiring, yet provided no written description of, a compound that could inhibit COX-2, and therefore the patent was invalid.<ref name="hodgsonruss">{{cite web |url=http://www.hodgsonruss.com/Home/Practice_Areas/Alphabetical_Listing/Intellectual_Property_Technology/Articles/20012004Articles/Reach-ThroughClaimsDeclaredInvalid |title=Reach-Through Claims Declared Invalid |access-date=31 December 2012 |archive-date=22 February 2014 |archive-url=https://web.archive.org/web/20140222060537/http://www.hodgsonruss.com/Home/Practice_Areas/Alphabetical_Listing/Intellectual_Property_Technology/Articles/20012004Articles/Reach-ThroughClaimsDeclaredInvalid |url-status=live }}</ref><ref name="kayescholer">Ranjana Kadle (2004) [https://web.archive.org/web/20130721100341/http://www.kayescholer.com/professionals/sobel_gerald_extras/misc/01_Rochester2_FedCir_Affirm.pdf CAFC Court Decision Reach-Through Claims Declared Invalid]</ref>

According to the [[National Academy of Sciences]], [[Philip Needleman]], who was vice president of [[Monsanto]] in 1989 and president of [[G. D. Searle & Company|Searle]] in 1993<ref name="NASO" /> oversaw research into [[COX-2]] that led to the development of the anti-inflammatory drug celecoxib (Celebrex).<ref name="NASO" /> He became senior executive vice president and chief scientist of [[Pharmacia]] from 2000 to 2003.<ref name="NASO">{{cite web | url=http://www.nasonline.org/news-and-multimedia/podcasts/interviews/philip-needleman.html?referrer=https://www.google.ca/ | title=Philip Needleman | publisher=National Academy of Sciences | date=15 June 2015 | access-date=28 December 2015 | archive-date=7 January 2016 | archive-url=https://web.archive.org/web/20160107133428/http://www.nasonline.org/news-and-multimedia/podcasts/interviews/philip-needleman.html?referrer=https%3A%2F%2Fwww.google.ca%2F | url-status=live }}</ref> Celecoxib was discovered and<ref>{{US patent | 5466823}}</ref> developed by G. D. Searle & Company and was approved by the FDA on 31 December 1998.<ref>{{cite web | title=Drug Approval Package: Celebrex (Celecoxib) NDA# 20-998 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20998.cfm | access-date=5 May 2020 | archive-date=27 March 2019 | archive-url=https://web.archive.org/web/20190327103438/https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20998.cfm | url-status=live }}</ref> It was co-promoted by Monsanto Company (parent company of Searle) and Pfizer under the brand name Celebrex. Monsanto merged with [[Pharmacia]], from which the Medical Research Division was acquired by Pfizer, giving Pfizer ownership of Celebrex. The drug was at the core of a major patent dispute that was resolved in Searle's favor (later Pfizer) in 2004.<ref name="hodgsonruss" /><ref name="kayescholer" /> In ''University of Rochester v. G.D. Searle & Co.'', 358 F.3d 916 (Fed. Cir. 2004), the [[University of Rochester]] claimed that United States Pat. No. 6,048,850 (which claimed a method of inhibiting COX-2 in humans using a compound, without actually disclosing what that compound might be) covered drugs such as celecoxib. The court ruled in favor of Searle, holding in essence that the university had claimed a method requiring, yet provided no written description of, a compound that could inhibit COX-2, and therefore the patent was invalid.

After the withdrawal of rofecoxib from the market in September 2004, celecoxib enjoyed a robust increase in sales. However, the results of the APC trial in December of that year raised concerns that Celebrex might carry risks similar to those of rofecoxib, and Pfizer announced a moratorium on [[direct-to-consumer advertising]] of Celebrex soon afterward. Sales reached $2 billion in 2006.<ref name="AHA2007"/> Before its availability in generic form, it was one of Pfizer's "best-selling drugs, amounting to more than $2.5 billion in sales [by 2012], and was prescribed to 2.4 million" people in 2011.<ref name=NYT2012 /> By 2012, 33 million Americans had taken celecoxib.<ref name=NYT2012>{{cite news | url=https://www.nytimes.com/2012/06/25/health/in-documents-on-pain-drug-celebrex-signs-of-doubt-and-deception.html | title=In Documents on Pain Drug, Signs of Doubt and Deception | work=[[The New York Times]] | date=24 June 2012 | access-date=27 December 2015 | vauthors = Thomas K | archive-date=3 January 2016 | archive-url=https://web.archive.org/web/20160103151323/http://www.nytimes.com/2012/06/25/health/in-documents-on-pain-drug-celebrex-signs-of-doubt-and-deception.html | url-status=live }}</ref>

Pfizer resumed advertising Celebrex in magazines in 2006,<ref name="Berenson">{{cite news |author=Berenson A |title=Celebrex Ads Are Back, Dire Warnings and All |work=The New York Times |date=29 April 2006 |url=https://www.nytimes.com/2006/04/29/business/media/29celebrex.html |access-date=21 February 2017 |archive-date=7 January 2016 |archive-url=https://web.archive.org/web/20160107133428/http://www.nytimes.com/2006/04/29/business/media/29celebrex.html |url-status=live }}</ref> and resumed television advertising in April 2007 with an unorthodox, {{frac|2|1|2}}-minute advertisement which extensively discussed the adverse effects of Celebrex in comparison with other anti-inflammatory drugs. The ad drew criticism from the consumer advocacy group [[Public Citizen]], which called the ad's comparisons misleading.<ref name="Saul">{{cite news |author=Saul S |title=Celebrex Commercial, Long and Unconventional, Draws Criticism |work=The New York Times |date=10 April 2007 |url=https://www.nytimes.com/2007/04/10/business/media/10celebrex.html |access-date=21 February 2017 |archive-date=17 January 2018 |archive-url=https://web.archive.org/web/20180117060825/http://www.nytimes.com/2007/04/10/business/media/10celebrex.html |url-status=live }}</ref> Pfizer responded to Public Citizen's concerns with assurances that they are truthfully advertising the risk and benefits of Celebrex as set forth by the FDA.<ref name="Saul"/>

In 2025, Australian [[Therapeutic Goods Administration]] decided  to include celecoxib 200mg as the first Schedule 3 (Pharmacist Only Medicine) selective COX-2 inhibitor in a primary pack containing not more than 10 dosage units for the short-term treatment of acute pain due to primary dysmenorrhoea or musculoskeletal or soft tissue injury in adults.<ref name=psa/>