Question 1

What is Montelukast used for?

Accepted Answer

Montelukast blocks leukotrienes to control asthma and allergic rhinitis symptoms.

Question 2

Is there a generic for Montelukast?

Accepted Answer

Yes. 46 ANDAs filed at FDA, 20 generic manufacturers currently shipping.

Question 3

How much does my plan pay for Montelukast?

Accepted Answer

Across 329 Part D plans, Montelukast averages $0.043/unit (NADAC). Lowest available: $0.043/unit. Highest in distribution: $0.043/unit.

Question 4

Is Montelukast on the FDA shortage list?

Accepted Answer

Montelukast has been discontinued by its manufacturer(s).

Question 5

What drug class is Montelukast in?

Accepted Answer

Montelukast is in the Leukotriene Receptor Antagonist class. See related drugs in this class at /class/leukotriene-receptor-antagonist.

Question 6

What is the brand name for Montelukast?

Accepted Answer

Montelukast is sold under the brand name SINGULAIR.

Question 7

Is SINGULAIR the same as Montelukast?

Accepted Answer

Yes. SINGULAIR is a brand name for Montelukast. The generic version is identical in active ingredient, dose, and FDA-approved indications. Pricing differs substantially: generic Montelukast typically prices well below brand SINGULAIR.

Question 8

How much does Medicare spend on Montelukast per year?

Accepted Answer

Medicare Part D spent $222.8M on Montelukast in CY2024, across 18.7M prescriptions and 5.9M unique beneficiaries.

Question 9

What can I switch to instead of Montelukast?

Accepted Answer

Same-class alternatives include: Zafirlukast. Whether substitution is clinically appropriate depends on patient indication, dose schedule, and contraindications — that is a P&T committee decision. The federal data shows cost and competition; clinical equivalence is not asserted here.

Question 10

Why isn't Montelukast cheaper if there's no PA friction?

Accepted Answer

Montelukast has 20 generic manufacturers and zero prior-authorization barriers across 329 Part D plans. Why it isn't already cheaper on most plans: tier placement and PBM contract structure, not clinical or supply factors. Moving the molecule to a lower formulary tier captures the savings — see leak report for sizing.

Question 11

When did the most recent Montelukast generic get approved?

Accepted Answer

The most recent ANDA approval for Montelukast is AMNEAL PHARMACEUTICALS OF NEW YORK LLC (ANDAANDA205107, approved 2020-09-04).

Question 12

When was Montelukast first FDA approved?

Accepted Answer

Montelukast received its first FDA approval on 2012-02-28.

Montelukast (SINGULAIR)

$222.8M in CY2024 Part D spend18.7M claims · 5.9M beneficiaries · 329 plans surveyed

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