Producer

Mallinckrodt / SpecGx

2

Inputs supplied

1

Goods downstream

0

Facilities

1

Stories

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2 inputs Mallinckrodt / SpecGx supplies

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Goods downstream

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Business segments

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  • Specialty Brands (Acthar / Therakos)

    40%
  • SpecGx Generics (Controlled Substances)

    33%
  • API and Chemical Manufacturing

    16%
  • Nuclear Imaging (divested / residual)

    5%

Intelligence

What's known

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  • Did you know2019

    Mallinckrodt / SpecGx — the generic opioid manufacturer that filed for bankruptcy twice over opioid litigation and paid hundreds of millions in settlements — is simultaneously the sole manufacturer in the world of Acthar Gel, a drug extracted from pig pituitary glands that is the primary treatment for infantile spasms (a catastrophic seizure disorder in infants) and is used for MS relapses and nephrotic syndrome. Acthar listed at ~$38,000 per 5mL vial at its price peak. When Mallinckrodt filed Chapter 11 in August 2023 for the second time, patients whose infants depended on Acthar for seizure control faced immediate supply uncertainty from the same company whose opioid practices had been prosecuted for contributing to the addiction crisis.

    Federal Trade Commission
  • Capacity2019

    Acthar Gel's price trajectory represents one of the most documented cases of pharmaceutical price exploitation: the drug listed at approximately $40 per vial in 2001 when Questcor acquired it; by 2014 when Mallinckrodt acquired Questcor for $5.6B, the price had already risen to ~$28,000/vial; by 2019 the list price reached ~$38,000/5mL vial. Since Acthar is a natural biological product with no biosynthetic equivalent and Mallinckrodt holds the sole manufacturing authorization, there is no market mechanism to discipline the price. The FTC alleged in 2019 that Mallinckrodt paid Novartis $135M to remove a competing synthetic ACTH product (Synacthen) from the market, further entrenching the monopoly. FTC antitrust complaint, January 2019.

    Federal Trade Commission
  • Origin2023

    Mallinckrodt traces to 1867, when German immigrant Thomas Mallinckrodt founded a chemical company in St. Louis making fine chemicals, including early ether and chloroform anesthetics. Over 150 years the company pivoted from industrial chemicals → pharmaceutical chemicals → controlled substances → specialty branded drugs → bankruptcy. The Acthar Gel acquisition (from Questcor, $5.6B, 2014) was the strategic bet that was supposed to fund the opioid litigation settlements — instead both businesses ended up in bankruptcy court simultaneously. Mallinckrodt went from being the first major US manufacturer of acetaminophen in the 1950s to being a defendant in both the opioid crisis and the Acthar price-gouging scandal by 2020.

    Mallinckrodt Pharmaceuticals
  • Concentration2019

    Mallinckrodt / SpecGx held 37.7% of all US opioid pills distributed between 2006–2012 and approximately 40% of the total US prescription opioid market. DEA investigators called Mallinckrodt "the kingpin within the drug cartel" of pharmaceutical opioid companies in 2010. The company distributed 28.9 billion oxycodone pills — more than 80 pills for every American — before filing for bankruptcy in October 2020 under the weight of opioid litigation. Its second bankruptcy in 2023 sought to escape a $1.7 billion settlement.

    Becker's Hospital Review