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ORIAHNN (COPACKAGED) Drug Patent Profile

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Which patents cover Oriahnn (copackaged), and when can generic versions of Oriahnn (copackaged) launch?

Oriahnn (copackaged) is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-eight patent family members in twenty-five countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Oriahnn (copackaged)

Oriahnn (copackaged) was eligible for patent challenges on July 23, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2029. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ORIAHNN (COPACKAGED)

International Patents:	98
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORIAHNN (COPACKAGED)
DailyMed Link:	ORIAHNN (COPACKAGED) at DailyMed

Drug patent expirations by year for ORIAHNN (COPACKAGED)

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORIAHNN (COPACKAGED)

Generic Entry Date for ORIAHNN (COPACKAGED)^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 213388 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.

Paragraph IV (Patent) Challenges for ORIAHNN (COPACKAGED)

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 ORIAHNN (COPACKAGED)

ORIAHNN (COPACKAGED) is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORIAHNN (COPACKAGED) is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ORIAHNN (COPACKAGED)

Methods of treating heavy menstrual bleeding
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

Processes for the preparation of uracil derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) USING 300 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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	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				⤷ 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 ORIAHNN (COPACKAGED)

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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 ORIAHNN (COPACKAGED)

See the table below for patents covering ORIAHNN (COPACKAGED) around the world.

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Country	Patent Number	Title	Estimated Expiration
South Africa	200600475	Pyrimidine-2,4-dione derivatives as gonadotripin-releasing hormone receptor antagonists	⤷ Sign Up
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
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
>Country	>Patent Number	>Title	>Estimated Expiration