ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM - Generic Drug Details
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What are the generic 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium has ninety-eight patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
| International Patents: | 98 |
| US Patents: | 8 |
| 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
*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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388-001 | May 29, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014143669 | ⤷ Sign Up | |
| Canada | 2977938 | FORMULATIONS PHARMACEUTIQUES DESTINEES AU TRAITEMENT DE L'ENDOMETRIOSE ET DES FIBROMES UTERINS (PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS AND UTERINE FIBROIDS) | ⤷ Sign Up |
| Cyprus | 1108656 | ⤷ Sign Up | |
| China | 111246850 | 用于治疗子宫内膜异位症、子宫肌瘤、多囊卵巢综合症以及子宫腺肌症的固体药物配制物 (Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis) | ⤷ Sign Up |
| Brazil | 112020003388 | formulações farmacêuticas sólidas para tratar endometriose, miomas uterinos, síndrome de ovário policístico e adenomiose | ⤷ Sign Up |
| Japan | 7350715 | ⤷ Sign Up | |
| Taiwan | 201919632 | Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
