Dulera discontinued: Is there an alternative available for Dulera?

Dulera treats and prevents asthma symptoms like wheezing and shortness of breath. It comprises mometasone and formoterol. In 2010, the US government approved the combo for medical use. Now, there isn’t a generic version available. It was the 288th most widely prescribed medication in the United States in 2020. This medication has over 2 million prescriptions.

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What is Dulera?

A famous prescription drug is called Dulera. It is used to treat adults with asthma and kids who are 5 years old and older.

Asthma is a disorder that causes your airways to expand and stiffen, making it difficult to breathe. Asthma symptoms that worsen suddenly are usually referred to as asthma attacks. These conditions cannot be treated with Dulera.

There are two drugs in Dulera. The first is mometasone, which belongs to the class of medications known as inhaled corticosteroids. (A class of drugs is a collection of drugs with similar means of action.) Inhaled corticosteroids help reduce swelling in the lungs.

Another drug found in Dulera is formoterol. It belongs to a class of medication called a long-acting beta-agonist (LABA). It relaxes the muscles in the airways.

Who manufactures Dulera?

Dulera is a dual-purpose respiratory medicine from Merck & Co. The medicine has received US Food and Drug Administration approval. On June 24, 2010, the American multinational pharmaceutical business Merck & Co., Inc. made this statement.

Patients 12 years of age and older can now be treated for asthma with this inhaled medication. It is not recommended for treating severe bronchospasm. Mometasone furoate and formoterol fumarate are a fixed-dose combination created by Schering-Plough. Merck passed it on when the latter company acquired its smaller rival in 2009.

This medicine combines the dual benefits of an inhaled corticosteroid and a long-acting beta-agonist (LABA). Thus, it helps to improve lung function in asthma patients. It competes with the market-leading Advair from GlaxoSmithKline Plc and Symbicort from AstraZeneca Plc. Both of them operate similarly.

In 2010, the FDA evaluated LABA medications seriously. They created revised warnings for the inhalation therapies earlier in May 2010.

Some analysts claimed the LABA safety concerns may have caused the FDA’s decision on Dulera. It was earlier anticipated, by April, to be postponed. Finally, the FDA revealed in an update on its website that clearance had been granted before Merck issued a press release. As a result, it was possible to approve the drug before the manufacturer.

By the end of July 2010, Merck projected that Dulera would be available in retail pharmacies all over the United States. A treatment for chronic obstructive pulmonary disease is also being studied and developed using this medicine.

Has Dulera’s generic version received approval?

No. Dulera is yet to be offered in a therapeutically similar form in the United States. A generic drug replicates the active ingredient found in a brand-name drug. The generic drug is considered equally secure and efficient as the brand-name medication. In general, generic medications are less expensive than name-brand ones.

Mometasone and formoterol are the two active medicinal ingredients found in Dulera. This indicates that the active components of Dulera are mometasone and formoterol.

As a result, Dulera is exclusively offered as a brand-name drug. There is yet to be a generic version available.

Unlawful generic Dulera may be offered for sale by dubious online pharmacies. These drugs could be risky counterfeits.

Drug dosages and strength

Dulera is available as a blue, single-use metered-dose inhaler. An actuator and a canister make up an inhaler. Mometasone and formoterol, the two active components of Dulera, are both present in the canister. The canister is held in place by the actuator. It also dispenses the medication in precisely timed puffs.

There are three strengths of Dulera:

  • 50 mcg mometasone/5 mcg formoterol
  • 100 mcg mometasone/5 mcg formoterol
  • 200 mcg mometasone/5 mcg formoterol

There are either 60 or 120 puffs in each canister. One dose is equal to two puffs. Therefore, a canister contains 30 or 60 dosages.

What does Dulera do to the patients?

Inflammation in your airways and lungs leads to swelling and increased mucus. It is a disorder known as asthma. In this case, breathing becomes more difficult.

The exact reason why some people have asthma and others don’t is unknown. According to the principle, inflammation is brought on by an overactive immune system in people with asthma. The immune system serves as the body’s line of defense against infections. Your airways become restricted due to the inflammation, making it more difficult for your body to get the oxygen it needs.

As we know, two medications are present in Dulera. One is the corticosteroid mometasone. The other is the long-acting beta2-agonist (LABA) formoterol. (mentioned above)

Corticosteroids help reduce lung inflammation. It will prevent more inflammation from affecting breathing. Long-acting beta2-agonists relax the muscles that surround the airways in the lungs. This opens up the airways, allowing more air to enter during inhalation.

Mometasone and formoterol act together to improve your breathing. They will get more oxygen into your lungs.

Effectiveness of Dulera

People with asthma who received Dulera or a placebo (a treatment with no active medication) were studied in clinical trials. Researchers assessed the participants’ forced expiratory volume (FEV1). This is the air that can be forcibly exhaled in one second. A measurement of a person’s trough FEV1 is performed 24 hours following their last medication use.

The trough FEV1 of those on Dulera increased on average by 0.13 L. In contrast, those who took a placebo saw an average drop in their trough FEV1 of 0.05 L.

In the same trial, 30% of those who took Dulera saw a gradual worsening of their asthma. This result is compared to 56% of those who received a placebo.

Similar exclusivities:

The FDA grants exclusivity as a marketing right after approving a medicine. It may or may not be used in conjunction with a patent. Exclusivity is a legal requirement for an NDA applicant, provided certain conditions are satisfied. Depending on the specifics of the exclusivity agreement, exclusivity periods range from 180 days to seven years.

Expiration dates for exclusivity: February 12, 2023: Pediatric Exclusivity.

Availability of generic Dulera

As we know, formoterol/mometasone is sold under the brand name Dulera. The FDA has approved the following formulations:

DULERA (formoterol fumarate; mometasone furoate, metered-dose aerosol)

  • Manufacturer: ORGANON LLC
  • Date of approval: June 22, 2010

Strengths: 0.005 mg/INH, 0.1 mg/INH, and 0.005 mg/INH, 0.2 mg/INH

  • Manufacturer: ORGANON LLC
  • Date of approval: August 12, 2019
  • Strength(s): 0.05 mg/INH and 0.005 mg/INH

Is there an alternative available for Dulera?

A long-acting beta2-agonist (LABA) and an inhaled corticosteroid (ICS) are both components of several popular brand-name combo inhalers. These inhalers include 

  • Breo Ellipta,
  • Symbicort,
  • AirDuo Digihaler,
  • AirDuo,
  • RespiClick, and
  • Advair Diskus.

More recently, generic versions of a few brand-name inhalers (Advair, AirDuo, and Symbicort) have become available. They are with the active ingredients fluticasone propionate/salmeterol and budesonide/formoterol. A generic combination inhaler for the two drugs in Dulera is not yet accessible.

The usual adverse effects of these alternative combo inhalers include

  • headaches,
  • hoarseness,
  • upper respiratory infections,
  • sinus infections, and
  • oral thrush.

Before discontinuing Dulera, you should consider some alternatives’ potential negative effects. Other potential asthma maintenance therapies include

  • single-medication inhalers, 
  • oral tablets and
  • injectables.

Your doctor should review a medication list before changing from Dulera to an alternative. It should include both prescription and over-the-counter medications. Drug interactions with certain alternatives must be avoided.

For instance, care should be taken when using ICS and LABA combination inhalers. It should be noted by those who are also taking ketoconazole, diuretics, or specific antidepressants. Before altering the course of therapy, always get medical advice from a medical professional.


Dulera is intended to be used over a longer period. Whatever the state of your breathing, whether it is good or bad, you should take Dulera every day.

Asthma attacks are abrupt breathing issues. They are not currently approved for treatment with Dulera. Your doctor may advise you to use a rescue inhaler if you experience asthma symptoms in the intervals between Dulera doses.

As far as we have studied, no recall information is available for this medication, Dulera.