.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 4,616,006

« Back to Dashboard

Claims for Patent: 4,616,006

Title: Triphasic oral contraceptive
Abstract:A method of contraception in which an estrogen and a progestogen are administered daily in a three phase sequence for 21 days is disclosed. In the first phase a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone is administered for 5-8 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.25-1.0 mg of norethindrone for 7-11 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.35-2.0 mg of norethindrone for 3-7 days; followed by 6-8 days without administering either an estrogen or a progestogen.
Inventor(s): Pasquale; Samuel A. (Basking Ridge, NJ)
Assignee: Ortho Pharmaceutical Corporation (Raritan, NJ)
Application Number:06/744,189
Patent Claims: 1. A triphasic oral contraceptive unit consisting of 21 separate dosage units, adapted for successive daily oral administration comprising:

7 dosage units containing, in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen and a progestogen at contraceptively effective dosages corresponding in activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone as the first phase; followed by 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding in activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.25-1.0 mg of norethindrone as the second phase; followed by 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.35-2.0 mg of norethindrone as the third phase, and optionally containing 7 dosage units free of estrogen and progestogen; provided that the estrogen daily dosage is the same in all three phases.

2. The unit according to claim 1 wherein the dosage units are in the form of tablets.

3. The unit according to claim 1 wherein the estrogen is selected from 17.alpha.-ethinylestradiol, estrone, estradiol and estriol.

4. The unit according to claim 2 wherein the estrogen is 17.alpha.-ethinylestradiol.

5. The unit according to claim 1 wherein the progestogen is selected from D-norgestrel, norethindrone, progesterone and D-17.beta.-acetoxy-13.beta.-ethyl-17.alpha.-ethinyl-gon-4-en-3-one oxime.

6. The unit according to claim 5 wherein the progestogen is norethindrone.

7. The unit according to claim 5 wherein the progestogen is D-17.beta.-acetoxy-13.beta.-ethyl-17.alpha.-ethinyl-gon-4-en-3-one oxime.

8. A composition according to claim 1 wherein the estrogen daily dosage in all three phases is equivalent to 0.035 mg of 17.alpha.-ethinylestradiol; and the progestogen daily dosage is equivalent to 0.50 mg of norethindrone in the first phase, 0.75 mg of norethindrone in the second phase and 1.0 mg of norethindrone in the third phase.

9. A composition according to claim 1 wherein the estrogen daily dosage in all three phases is equivalent to 0.035 mg of 17.alpha.-ethinylestradiol; and the progestogen daily dosage is equivalent to 0.180 mg of norgestimate in the first phase, 0.215 mg of norgestimate in the second phase and 0.250 mg of norgestimate in the third phase.

10. A triphasic oral contraceptive unit consisting of 21 separate dosage units, adapted for successive daily oral administration comprising:

5-8 dosage units containing, in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen and a progestogen at contraceptively effective dosages corresponding in activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone as the first phase; followed by 7-11 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding in activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.25-1.0 mg of norethindrone as the second phase; followed by 3-7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.35-2.0 mg of norethindrone as the third phase, and optionally containing 6-8 dosage units free of estrogen and progestogen; provided that the estrogen daily dosage is the same in all three phases.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc