Pronova BioPharma is a Norwegian company. In Denmark it is a bulk manufacturer of omega-3 products with a manufacturing plant in

Kalundborg Kalundborg () is a Danish city with a population of 16,659 (1 January 2025),BASF BASF SE (), an initialism of its original name , is a European Multinational corporation, multinational company and the List of largest chemical producers, largest chemical producer in the world. Its headquarters are located in Ludwigshafen, Ge ...

in 2014. Pronova BioPharma ASA had its roots in Norway's codfish liver oil 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

omega-3-acid ethyl esters Omega-3-acid ethyl esters are a mixture of ethyl eicosapentaenoate and ethyl docosahexaenoate, which are ethyl esters of the omega−3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) found in fish oil. Together with d ...

formulation that is the

active pharmaceutical ingredient An active ingredient is any ingredient that provides biological activity, biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of ...

of Lovaza.Adis Insigh
Omega-3 ethylester concentrate
Page accessed March 31, 2016

Lovaza

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 Pierre Fabre 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,VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. October 200
National PBM Drug Monograph Omega-3-acid ethyl esters (Lovaza, formerly Omacor)
/ref> and it was launched in the US and Europe in 2005. Global sales in 2005 were $144M, and by 2008, they were $778M. By 17 November 2010, the constituent companies of the OSEAX included Pronova BioPharma. In 2009, generic companies

Teva Pharmaceuticals Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational Pharmaceutical industry, pharmaceutical company. Teva specializes primarily in generic drugs, but other business interests include branded-drug ...

and Par Pharmaceutical made clear their intentions to file

Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, ...

s (“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. Generic versions of Lovaza were introduced in America in April 2014. Pronovo has continued to manufacture the ingredients in Lovaza, and in 2012,

BASF BASF SE (), an initialism of its original name , is a European Multinational corporation, multinational company and the List of largest chemical producers, largest chemical producer in the world. Its headquarters are located in Ludwigshafen, Ge ...

announced it would acquire Pronova for $844 million. The deal closed in 2013.

Research

Pronova BioPharma is a commercial partner in MabCent-SFI.

Brand names

* Lovaz (US)/Omacor (Europe), sold by Woodward Pharma Services, LLC in the US; created and manufactured by Pronova.University of Utah Pharmacy Services (August 15, 2007) "Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza"
It was approved in the United States in 2004.

References

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External links

https://www.epax.com/why-epax/about-us/ Chemical companies Chemical companies established in 1991