Details for New Drug Application (NDA): 213388
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NDA 213388 describes ORIAHNN (COPACKAGED), which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ORIAHNN (COPACKAGED) profile page.
The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium,estradiol,norethindrone acetate; elagolix sodium profile page.
The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium,estradiol,norethindrone acetate; elagolix sodium profile page.
Summary for 213388
| Tradename: | ORIAHNN (COPACKAGED) |
| Applicant: | Abbvie |
| Ingredient: | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213388
Generic Entry Date for 213388*:
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.
Suppliers and Packaging for NDA: 213388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388 | NDA | AbbVie Inc. | 0074-1017 | 0074-1017-14 | 1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK |
| ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate; elagolix sodium | CAPSULE;ORAL | 213388 | NDA | AbbVie Inc. | 0074-1017 | 0074-1017-56 | 4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ||||
| Approval Date: | May 29, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) | ||||||||
Expired US Patents for NDA 213388
| 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 |
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