Elagolix sodium - Generic Drug Details
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What are the generic sources for elagolix sodium and what is the scope of patent protection?
Elagolix sodium
is the generic ingredient in two branded drugs marketed by Abbvie and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elagolix sodium has one hundred and one patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for elagolix sodium
International Patents: | 101 |
US Patents: | 15 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 8 |
Patent Applications: | 106 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for elagolix sodium |
DailyMed Link: | elagolix sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elagolix sodium
Generic Entry Date for elagolix sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.
Recent Clinical Trials for elagolix sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AbbVie | Phase 3 |
AbbVie (prior sponsor, Abbott) | Phase 2 |
AbbVie | Phase 2 |
Pharmacology for elagolix sodium
Drug Class | Gonadotropin Releasing Hormone Receptor Antagonist |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors |
Physiological Effect | Decreased GnRH Secretion |
Anatomical Therapeutic Chemical (ATC) Classes for elagolix sodium
Paragraph IV (Patent) Challenges for ELAGOLIX SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ORILISSA | Tablets | elagolix sodium | 150 mg and 200 mg | 210450 | 9 | 2022-07-25 |
US Patents and Regulatory Information for elagolix sodium
Expired US Patents for elagolix sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for elagolix sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3073229 | FORMULATIONS PHARMACEUTIQUES POUR LE TRAITEMENT DE L'ENDOMETRIOSE, DE FIBROMES UTERINS, DU SYNDROME DES OVAIRES POLYKYSTIQUES OU DE L'ADENOMYOSE (PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME OR ADENOMYOSIS) | ⤷ Sign Up |
Australia | 2004257639 | Pyrimidine-2, 4-dione derivatives as gonadotropin-releasing hormone receptor antagonists | ⤷ Sign Up |
Hong Kong | 1258062 | 給予惡拉戈利的方法 (METHODS OF ADMINISTERING ELAGOLIX) | ⤷ Sign Up |
Denmark | 1646389 | ⤷ Sign Up | |
Norway | 20056251 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2014143669 | ⤷ Sign Up | |
Australia | 2018419533 | Methods of treating heavy menstrual bleeding | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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