Abbvie ireland nl b.v. (ирландия)

AbbVie History

AbbVie officially separated from Abbott Laboratories in January 2013. Abbott wanted to concentrate on medical devices such as heart stents. This allowed AbbVie to focus on research-based pharmaceuticals.

AbbVie’s Notable Pharmaceutical Accomplishments

  • April 2013
    AbbVie releases its first branded product (Humira)
  • November 2014
    Brands serve more than 30 million people worldwide
  • December 2014
    First AbbVie-created medicine Viekira Pak gains U.S. approval
  • January 2105
    FDA approves Parkinson’s disease medicine Duopa
  • September 2015
    Humira becomes the first and only approved treatment of hidradenitis suppurativa, a chronic inflammatory skin disease
  • March 2016
    AbbVie gains new approvals for Imbruvica and Venclexta/Venclyxto
  • April 2016
    AbbVie acquires Stemcentrx to expand oncology presence
  • June 2016
    FDA approves Humira to treat an immune-mediated disease that can impair vision
  • June 2017
    Reputation Institute names AbbVie 2017’s most reputable pharmaceutical company
  • July 2017
    Maviret/Mavyret receives approval
  • October 2017
    FDA grants AbbVie priority review of investigational treatment for endometriosis management
  • July 2018
    FDA approves AbbVie’s oral treatment of endometriosis, Orilissa
  • November 2018
    FDA grants accelerated approval for a treatment of newly diagnosed acute myeloid leukemia patients
  • June 2019
    AbbVie and Allergan announce that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan

AbbVie Products

AbbVie makes more than 30 products and has more than 50 drugs in development. Several of the company’s pharmaceuticals rake in billions annually. These include Humira, Imbruvica and Viekira.

By far, AbbVie’s biggest sales generator is Humira. Doctors prescribe the drug to treat arthritis, psoriasis and Crohn’s disease. It accounts for more than half of AbbVie’s total annual sales.

AbbVie Pharmaceutical Products

Testosterone (male hormone) gel
Anti-seizure medication
Drug for arthritis, Crohn’s disease and other immune-mediated inflammatory diseases
Synthetic cannabinoid (man-made delta-9-tetrahydrocannabinol or THC)
Treats high cholesterol and triglycerides (fat)
Macrolide antibiotic
Muscle relaxer
Antiretroviral (HIV) medication
Thyroid hormone
Man-made form of vitamin D that prevents and treats increased parathyroid hormone levels in patients with chronic kidney failure
Inhaled anesthetic

AbbVie’s Humira Patent Fight

Humira was the world’s top-selling prescription drug in 2015, according to The New York Times.

The drug brought in $16 billion for AbbVie in 2016. Estimates for 2017 show increases of more than 15 percent in the U.S. and 6.5 percent abroad.

AbbVie is trying to block biosimilar competition by filing new patents. AbbVie has filed more than 70 new patents on Humira.

In May 2017, AbbVie lost one round to the company Coherus. But according to Fortune, other patents should protect AbbVie’s sales through 2022.

Medical Marijuana and AbbVie

Some analysts classify AbbVie as a maker of medical marijuana.

AbbVie’s Marinol was the first FDA-approved cannabis drug. Solvay Pharmaceuticals developed the drug. Abbott acquired Solvay’s pharmaceutical division in 2010 and took on Marinol as well.

Marinol was the first FDA-approved cannabis drug.

Doctors prescribe Marinol to patients with nausea and vomiting from cancer medications. People with AIDs use it to combat lack of appetite.

Its active ingredient is a synthetic cannabinoid – man-made delta-9-tetrahydrocannabinol or THC. This main ingredient gives the drug its effects.

Abbvie doesn’t release Marinol’s sales numbers. This leads analysts to believe it’s not very profitable. But future developments on legalization may change the long-term outlook of the drug.

AbbVie Recalls

AbbVie has had to recall some of its products. Reasons include labeling errors, possible contamination and harmful drug effects.

Its multiple sclerosis drug Zinbryta was pulled from the shelves altogether in March 2018. It led to the deaths of three patients. The drug was a joint venture with Biogen.

Notable AbbVie Recalls

  • 2013

    Product recalled

    Reason for recall

    Labeling error; a bottle contained a lower dose

  • 2015

    Product recalled

    Zemplar injection
    Reason for recall

    Single vial contained a free-flowing glass particle

  • 2018

    Product recalled

    Zinbryta (MS drug)
    Reason for recall

    Reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, and patient deaths; possible severe immune reactions affecting other body organs

AbbVie Lawsuits and Settlements

AbbVie faces thousands of personal injury lawsuits. People blame the company’s products for serious injuries and deaths. The lawsuits accuse the company of failing to warn about its drugs’ risks.

The company’s biggest seller, Humira, is the subject of some of these lawsuits. AbbVie’s testosterone replacement treatment AndroGel and its anti-seizure medication Depakote have also led to lawsuits.

Humira Lawsuits

Humira lawsuits blame the drug for fungal infections, nerve damage, and an increased risk of cancer in children and adolescents. In 2013, a jury ordered AbbVie to pay $2.24 million to a patient who suffered from a fungal infection. Some patients have died from these infections, according to the FDA.

AndroGel Lawsuits

More than 7,750 men have filed testosterone lawsuits against AbbVie and other manufacturers of testosterone replacement therapy products. Nearly 6,000 remained pending in federal court in Illinois in June 2018. AndroGel lawsuits blame the product for blood clots, heart attack, stroke and sudden death.

AndroGel lawsuits say AbbVie marketed the therapy for the natural signs of aging, while downplaying the risks.

Depakote Lawsuits

Depakote lawsuits say children suffered birth defects after their mothers took Depakote during pregnancy. AbbVie assumed all rights and responsibilities for Depakote when it separated from Abbott. In June 2018, a judge halted more than 600 lawsuits so lawyers on both sides could discuss settlements.