Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium - Generic Drug Details
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What are the generic drug sources for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium and what is the scope of patent protection?
Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium has fifty-five patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
| International Patents: | 55 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium |
| DailyMed Link: | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
Generic Entry Date for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Anatomical Therapeutic Chemical (ATC) Classes for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
Paragraph IV (Patent) Challenges for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ORIAHNN (COPACKAGED) | Capsules | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | 300 mg/1 mg/ 0.5 mg; 300 mg | 213388 | 1 | 2022-11-03 |
US Patents and Regulatory Information for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 280135 | הרכבי נתרן אלאגוליקס ותהליכים (Elagolix sodium compositions and processes) | ⤷ Try a Trial |
| New Zealand | 731834 | Compositions for use in treating heavy menstrual bleeding and uterine fibroids | ⤷ Try a Trial |
| Japan | 5226760 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
