US8679533 — Pramipexole once-daily dosage form
Method of Use · Assigned to Pharmacia LLC · Expires 2029-09-08 · 3y remaining
What this patent protects
This patent protects a once-daily dosage form of pramipexole dihydrochloride that releases the active ingredient in a controlled manner.
USPTO Abstract
An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
Drugs covered by this patent
FDA Patent Use Codes
When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.
| Code | Description | Drug |
|---|---|---|
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
U-219 |
— | pramipexole-dihydrochloride |
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
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