BROMOCRIPTINE MESYLATE generics — when can they launch?
BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE) · · 13 active US patents · 0 expired
Where BROMOCRIPTINE MESYLATE sits in the generic timeline
Mid-term cliff: earliest active US patent for BROMOCRIPTINE MESYLATE expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 13 patents
FDA U-codes carved out by BROMOCRIPTINE MESYLATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2898 | (no description) |
U-1706 | (no description) |
U-2111 | (no description) |
U-2285 | (no description) |
U-2393 | (no description) |
U-976 | (no description) |
U-4015 | (no description) |
U-1939 | (no description) |
U-2190 | (no description) |
U-2871 | (no description) |
U-3119 | (no description) |
Sample patent estate
Showing 6 of 13 active US patents. View full estate on the BROMOCRIPTINE MESYLATE drug page →
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This patent protects a method of treating a metabolic disorder using a combination of a dopamine agonist and a first-phase insulin secretagogue.USPTO title: Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
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This patent protects a method of treating a metabolic disorder using a combination of a dopamine agonist and a first-phase insulin secretagogue.USPTO title: Combination of dopamine agonists plus first phase secretagogues for the treatment of metabolic disorders
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This patent protects a method of treating a metabolic disorder using a combination of a dopamine agonist and a first-phase insulin secretagogue.USPTO title: Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
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This patent protects a method of treating a metabolic disorder using a combination of a dopamine agonist and a first-phase insulin secretagogue.USPTO title: Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
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This patent protects pharmaceutical formulations of bromocriptine mesylate for improving glycemic control in the treatment of type 2 diabetes.USPTO title: Bromocriptine formulations
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This patent protects pharmaceutical formulations of bromocriptine mesylate for improving glycerine control in the treatment of type 2 diabetes.USPTO title: Bromocriptine formulations
Sources
- FDA Orange Book — patents listed against BROMOCRIPTINE MESYLATE (NDA filed 1978)
- BROMOCRIPTINE MESYLATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2030 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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