Details for New Drug Application (NDA): 210450
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NDA 210450 describes ORILISSA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ORILISSA profile page.
The generic ingredient in ORILISSA is elagolix sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.
The generic ingredient in ORILISSA is elagolix sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.
Summary for 210450
| Tradename: | ORILISSA |
| Applicant: | Abbvie |
| Ingredient: | elagolix sodium |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210450
Generic Entry Date for 210450*:
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.
Pharmacology for NDA: 210450
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors |
| Physiological Effect | Decreased GnRH Secretion |
Suppliers and Packaging for NDA: 210450
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0038 | 0074-0038-07 | 1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
| ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0038 | 0074-0038-28 | 4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 23, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,537,572 | Patent Expiration: | Sep 1, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN | ||||||||
| Patent: | 10,682,351 | Patent Expiration: | Sep 1, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE | ||||||||
| Patent: | 11,542,239 | Patent Expiration: | Jul 23, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 210450
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | 7,056,927 | ⤷ Start Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | 7,176,211 | ⤷ Start Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | 6,872,728 | ⤷ Start Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | 7,179,815 | ⤷ Start Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | 7,179,815 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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