FDA Approves Generic Symbicort for Asthma, COPD

Full approval by the FDA follows tentative approval for the complex drug delivery advice for asthma and chronic obstructive pulmonary disease (COPD) granted by the FDA last week amid a patent dispute.

The FDA Tuesday approved the first generic metered dose inhaler (MDI) of budesonide and formoterol fumarate dihydrate (Symbicort) for asthma in patients aged 6 and older and for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” Sally Choe, PhD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, in a statement. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective, and affordable medicines for patients and consumers.”

Budesonide is a corticosteroid that reduces inflammation, and formoterol is a long-acting bronchodilator that relaxes airway muscles; the MDI is used twice a day, 2 inhalations each time. The inhaler is approved for 2 strengths: 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.

There is ongoing patent litigation between AstraZeneca, the maker of Symbicort, and Viatris, formerly known as Mylan Pharmaceuticals, and its drug delivery device partner Kindeva Drug Delivery LP.

The FDA gave tentative approval to the product last week amid the patent dispute; on March 2, the US District Court for the Northern District of West Virginia ruled in favor of AstraZeneca, finding that the challenge over some of the company’s Symbicort patents “are not invalid for obviousness.” Viatris and Kindeva said last week they plan to appeal the decision.

Symbicort generated $3.5 billion in sales for AstraZeneca for the 12 months ending in January 2021, Viatris said.

The most common adverse effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

For those with COPD, the most common adverse effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.