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Last Updated: June 28, 2022

ORIAHNN (COPACKAGED) Drug Patent Profile


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Which patents cover Oriahnn (copackaged), and what generic alternatives are available?

Oriahnn (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-seven 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) will be eligible for patent challenges on July 23, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for ORIAHNN (COPACKAGED)
International Patents:37
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:ORIAHNN (COPACKAGED) at DailyMed
Drug patent expirations by year for ORIAHNN (COPACKAGED)
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORIAHNN (COPACKAGED)
Generic Entry Date for ORIAHNN (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for ORIAHNN (COPACKAGED)

ORIAHNN (COPACKAGED) is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORIAHNN (COPACKAGED) is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

Methods of treating heavy menstrual bleeding
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)

Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ORIAHNN (COPACKAGED)

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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)

International Patents for ORIAHNN (COPACKAGED)

When does loss-of-exclusivity occur for ORIAHNN (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04257639
Estimated Expiration: See Plans and Pricing

Austria

Patent: 7679
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0412314
Estimated Expiration: See Plans and Pricing

Canada

Patent: 31508
Estimated Expiration: See Plans and Pricing

China

Patent: 19829
Estimated Expiration: See Plans and Pricing

Patent: 0424078
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0080646
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08656
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46389
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0370
Estimated Expiration: See Plans and Pricing

Patent: 0600190
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46389
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004016516
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2833
Estimated Expiration: See Plans and Pricing

Japan

Patent: 22844
Estimated Expiration: See Plans and Pricing

Patent: 26760
Estimated Expiration: See Plans and Pricing

Patent: 07521309
Estimated Expiration: See Plans and Pricing

Patent: 11088902
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06000297
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4747
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4897
Estimated Expiration: See Plans and Pricing

Patent: 056251
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46389
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46389
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46389
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0600475
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1139148
Estimated Expiration: See Plans and Pricing

Patent: 060031851
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14448
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Portugal 1255738 See Plans and Pricing
Denmark 1255738 See Plans and Pricing
Canada 2531508 DERIVES DE PYRIMIDINE-2, 4-DIONE UTILISES COMME ANTAGONISTESDU RECEPTEUR D'HORMONE LIBERANT DE LA GONADOTROPHINE (PYRIMIDINE-2, 4-DIONE DERIVATIVES AS GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS) See Plans and Pricing
Australia 2004257639 Pyrimidine-2, 4-dione derivatives as gonadotropin-releasing hormone receptor antagonists See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.