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Mobic generic
About Mobic
Mobic (MELOXICAM) — originally marketed by Boehringer Ingelheim. Class: Nonsteroidal Anti-inflammatory Drug [EPC]. First approved 2000-01-01.
Approved generic versions (0)
Originator patent timeline
Active patents (11)
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12263176· Formulation · US - —
12059423· Compound · US - —
11458145· Method of Use · US - —
10881663· Method of Use · US - —
9808468· Method of Use · US - —
9649318· Formulation · US - —
9526734· Formulation · US - —
8545879· Formulation · US - —
9974746· Formulation · US - —
10709713· Method of Use · US - —
11253478· Formulation · US
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.
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Related
- Mobic full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing