Oxybutynin therapy
Nickname - "The pharmaceutical 'delivery rate' patent"
A composition comprising oxybutynin, a dosage form comprising oxybutynin, and a method for administering oxybutynin are disclosed for oxybutynin therapy.
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1. A sustained-release oxybutynin formulation for oral administration to a patient comprising a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 20% of the oxybutynin in 0 to 4 hours, from 20 to 50% of the oxybutynin in 0 to 8 hours, from 50 to 85% of the oxybutynin in 0 to 14 hours, and greater than 75% of the oxybutynin in 0 to 24 hours for treating incontinence in the patient.
2. A sustained-release oxybutynin formulation for oral administration to a patient in need of treatment for urge incontinence comprising a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.25 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating urge incontinence in the patient.
3. A sustained-release oxybutynin solid dosage form for oral administration to a patient for treating incontinence comprising an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that administers up to 2 mg of the member in 0 to 4 hours, from 2 mg to 5 mg of the member in 0 to 8 hours, from 5 mg to 8.5 mg of the member in 0 to 14 hours, and greater than 7.5 mg in 0 to 24 hours for treating incontinence in the patient.
4. A sustained-release oxybutynin dosage form for oral administration to a patient for treating incontinence comprising an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that administers up to 3 mg in 0 to 4 hours, 3 mg to 7.5 mg in 0 to 8 hours, 8 mg to 13 mg in 0 to 14 hours, and 12 mg to 15 mg in 0 to 24 hours for treating incontinence in the patient.
5. A dosage form for the oral administration of oxybutynin to a patient for treating incontinence, wherein the dosage form comprises a therapeutic dose of oxybutynin that is administered in a sustained-release cumulative dose of 0.2% to 80% over 2 to 16 hours.
6. The dosage form for the oral administration of oxybutynin according to claim 5, wherein the dosage form comprises a dose of 5 mg to 20 mg of oxybutynin.
7. The dosage form for the oral administration of oxybutynin according to claim 5, wherein the dosage form is a pharmaceutically acceptable tablet.
8. A dosage form for the oral administration of oxybutynin to a patient for treating incontinence, wherein the dosage form comprises a therapeutic dose of oxybutynin that is administered in a sustained release rate of 0.5% to 7% per hour over 30 minutes to 22 hours.
9. The dosage form for the oral administration of oxybutynin according to claim 8, wherein the dosage form comprises a dose of 5 mg to 20 mg of oxybutynin.
10. The dosage form for the oral administration of oxybutynin according to claim 8, wherein the dosage form is a pharmaceutically acceptable solid tablet.
11. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that is delivered from 0 to 20% of the dose in 0 to 4 hours, from 20 to 50% of the dose in 0 to 8 hours, from 50 to 85% of the dose in 0 to 14 hours, and greater than 75% of the dose in 0 to 24 hours for treating incontinence in the patient.
12. The method for treating incontinence in a patient according to claim 11, wherein the therapeutic dose is 1 mg to 100 mg.
13. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt which oxybutynin is administered in from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.25 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating incontinence in the patient.
14. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a therapeutic dose of an oxybutynin and its pharmaceutically acceptable salt, which oxybutynin is administered in up to 2 mg in 0 to 4 hours, 2 mg to 5 mg in 0 to 8 hours, 5 mg to 8 mg in 8.5 mg in 0 to 14 hours, and greater than 7.5 mg in 0 to 24 hours for treating incontinence in the patient.
15. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, which oxybutynin is administered in up to 3 mg in 0 to 4 hours, 3 mg to 7.5 mg in 0 to 8 hours, 8 mg to 13 mg in 0 to 14 hours, and 12 mg to 15 mg in 0 to 24 hours for treating incontinence in the patient.
16. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a dosage form comprising a therapeutic dose of oxybutynin that is administered in a sustained-release cumulative dose of 0.2% to 80% over 2 to 16 hours for treating incontinence.
17. The method for treating incontinence in a patient according to claim 16, wherein the therapeutic dose comprises 5 to 15 mg of oxybutynin.
18. The method for treating incontinence in a patient according to claim 16, wherein the dosage form is a pharmaceutically acceptable tablet.
19. A method for treating incontinence in a patient, wherein the method comprises administering orally to the patient a dosage form comprising a therapeutic dose of oxybutynin that is administered in a sustained release rate of 0.5% to 7% per hour over 30 minutes to 22 hours for treating incontinence.
20. The method for treating incontinence in a patient according to claim 19, wherein the therapeutic dose comprises 5 to 15 mg of oxybutynin.
21. The method for treating incontinence in a patient according to claim 19, wherein the dosage form is a pharmaceutically acceptable tablet.
Comments from the community
4 comments have been received for United States Patent No. 6,124,355. Want to add another?
#1|FizzMaster comments:
In Alza v. Impax Laboratories (06-1047), the Court of Appeals for the Federal Circuit affirmed a finding of invalidity made by the Northern District of California regarding claims 1, 2, 3, 4, 11, 13, 14, and 15 of the '355 patent.
A .pdf of the decision is available at the following URL:
NOTE: The Court's decision in Alza v. Impax Laboratories is flagged as non-precedential pursuant to Fed. Cir. R. 47.6.
#2|FizzMaster comments:
The Federal Circuit seperately affirmed a finding of invalidity for claims 1 through 3, 11, 13, and 14 of the '355 patent in Alza v. Mylan Laboratories (06-1019).
In Alza v. Mylan Laboratories, the Court employed a construction of the term 'delivers' (see claim 1 and claim 2) that refers to the rate of in vivo release in the gastrointestinal tract. In finding noninfringement, the Court noted the failure of Alza's evidence to address this claim limitation. Specifically, the Court rejected Alza's evidence relating to in vitro dissolution rates and in vivo accumulation rates in the bloodstream as irrelevant.
The Court noted that, as of 1995, "...a person of ordinary skill in the art would have expected a general, albeit imperfect, correlation between a drug's lipophilicity and it colonic absorptivity."
A .pdf of that decision is available at the following URL:
NOTE: The Alza v. Mylan Laboratories case is not flagged as non-precedential.
#3|Nipper comments:
Dennis Crouch has posted a thorough analysis of the Alza decision, including its interesting relationship to KSR v. Teleflex, which sits pending on the Supreme Court's docket, at the following URL:
Hal Wegner even went so far as to call the Alza opinion an amicus brief from a Federal Circuit panel for consideration by the Supremes in KSR.
#4|FizzMaster comments:
A press release from Mylan Laboratories regarding the Federal Circuit's decision in Alza v. Mylan Laboratories is available at the following URL: