82:(“ANDAs”) to bring generics to market, and in April 2009, Pronova sued them from infringing the key US patents covering Lovaza, US 5,656,667 (due to expire in April 2017), US 5,502,077 (exp March 2013). Subsequently, in May 2012, a district court ruled in Pronova's favor, saying that the patents were valid. The generic companies appealed, and in September 2013, the Federal Circuit reversed, saying that because more than one year before Pronova's predecessor company applied for a patent, it had sent samples of the fish oil used in Lovaza to a researcher for testing. This event thus constituted "public use" that invalidated the patent in question.
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in France. In 2004, Pronova licensed the US and Puerto Rican rights to
Reliant Therapeutics, whose business model was in-licensing of cardiovascular drugs. In that same year, Reliant and Pronova won FDA approval for the drug, and it was launched in the US and Europe in 2005. Global sales in 2005 were
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Pronova won approvals to market the drug, called Omacor in Europe (and initially in the US), in several
European countries in 2001 after conducting a three-and-a-half-year trial in 11,000 subjects; The company partnered with other companies like
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United States Court of
Appeals for the Federal Circuit. Pronova Biopharma Norge AS vs Teva Pharmaceuticals, Inc and Par Pharmaceutical. 2012-1498, -1499. Decided September 12, 2013
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industry. The company was founded in 1991 as a spinout from the JC Martens company, which in turn was founded in 1838 in Bergen, Norway. Pronova developed the concentrated
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Lovaz (US)/Omacor (Europe), sold by
Woodward Pharma Services, LLC in the US; created and manufactured by Pronova. It was approved in the United States in 2004.
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University of Utah
Pharmacy Services (August 15, 2007) "Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza"
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VHA Pharmacy
Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. October 2005
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63:$ 144M, and by 2008, they were $ 778M. By 17 November 2010, the constituent companies of the
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Press
Release: US District Court rules in Pronova BioPharma's favour on Lovaza(TM) patents
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National PBM Drug
Monograph Omega-3-acid ethyl esters (Lovaza, formerly Omacor)
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announced it would acquire
Pronova for $ 844 million. The deal closed in 2013.
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Pronovo has continued to manufacture the ingredients in Lovaza, and in 2012,
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BASF to snap up fish oil drugmaker
Pronova BioPharma in $ 844M buyout
385:"A Comparative Overview of Prescription Omega-3 Fatty Acid Products"
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is a Norwegian company. In Denmark it is a bulk manufacturer of
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Teva puts GSK and Amarin on notice with generic Lovaza launch
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Pronova Biopharma Pharmaceutical Production Facility, Denmark
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versions of Lovaza were introduced in America in April 2014.
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Fed. Circ. Nixes Pronova's Patent Win Against Teva, Par
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Eric Palmer for FierceManufacturing. January 22, 2013
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Tracy Staton for FiercePharmaMarketing April 9, 2014
340:Ryan McBride for FierceBiotech. November 21, 2012
133:"Store nedskrivninger giver kæmpetab hos Pronova"
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354:BASF lands Pronova making it a top omega-3 maker
37:Pronova BioPharma ASA had its roots in Norway's
195:Staff, ICIS Chemical Business. 26 March 2001
101:Pronova BioPharma is a commercial partner in
209:German Court Invalidates Omega-3 Drug Patent
207:Amanda Ernst for Law360 November 27, 2007
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304:Ryan Davis for Law360 September 12, 2013
427:https://www.epax.com/why-epax/about-us/
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451:Chemical companies established in 1991
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78:made clear their intentions to file
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80:Abbreviated New Drug Applications
47:active pharmaceutical ingredient
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292:Pronova BioPharma May 29, 2012
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235:. Page accessed March 31, 2016
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183:Pharma Times. March 22, 2001.
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172:Omega-3 ethylester concentrate
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26:with a manufacturing plant in
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185:Pronova wins Omacor approval
174:Page accessed March 31, 2016
161:Page accessed March 31, 2016
67:included Pronova BioPharma.
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70:In 2009, generic companies
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43:omega-3-acid ethyl esters
318:Federal Circuit Decision
45:formulation that is the
370:March 3, 2016, at the
281:U.S. patent 5,502,077
268:U.S. patent 5,656,667
248:. Oslo Stock Exchange
30:. It was acquired by
246:"OSEAX Constituents"
72:Teva Pharmaceuticals
446:Chemical companies
76:Par Pharmaceutical
39:codfish liver oil
20:Pronova BioPharma
16:Norwegian company
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252:17 November
139:(in Danish)
109:Brand names
103:MabCent-SFI
49:of Lovaza.
435:Categories
119:References
34:in 2014.
28:Kalundborg
389:P & T
411:26681905
368:Archived
143:16 March
137:MedWatch
97:Research
402:4671468
159:History
84:Generic
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53:Lovaza
157:Epax
65:OSEAX
441:BASF
407:PMID
254:2010
145:2015
91:BASF
74:and
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