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Singulair generic
About Singulair
Singulair (montelukast) — originally marketed by Merck & Co.. Class: Leukotriene receptor antagonist (LTRA). First approved 1998-02-20.
Approved generic versions (11)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| montelukast (Singulair) | University of Bologna | marketed | ||
| montelukast vs pretreatment with albuterol | University of New Mexico | marketed | ||
| Montelukast (High FeNO group) | Hull University Teaching Hospitals NHS Trust | marketed | ||
| Montelukast chewable tablets | Organon and Co | marketed | ||
| montelukast (MON) | GlaxoSmithKline | marketed | ||
| Montelukast Oral Granules | Vanderbilt University Medical Center | marketed | ||
| Montelukast (drug) | Firestone Institute for Respiratory Health | marketed | ||
| Montelukast,mometazon froat | Istanbul Training and Research Hospital | marketed | ||
| Montelukast (Low FeNO group) | Hull University Teaching Hospitals NHS Trust | marketed | ||
| Montelukast placebo granüle | Kecioren Education and Training Hospital | marketed | ||
| montelukast and cetirizine | Medical University of Lodz | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.