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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in twenty-three 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 September 10, 2024. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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:	55
US Patents:	7
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)^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Anatomical Therapeutic Chemical (ATC) Classes for ORIAHNN (COPACKAGED)

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

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 seven US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

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

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting ORIAHNN (COPACKAGED)

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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	⤷ 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

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
World Intellectual Property Organization (WIPO)	2020023459		⤷ Try a Trial
Israel	172833	PYRIMIDINE-2,4-DIONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME	⤷ Try a Trial
Spain	2314448		⤷ Try a Trial
Norway	20056251		⤷ Try a Trial
Canada	3174571	METHODES D'ADMINISTRATION D'ELAGOLIX (METHODS OF ADMINISTERING ELAGOLIX)	⤷ Try a Trial
Norway	334897		⤷ Try a Trial
Austria	407679		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration