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 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 |
-patent-expirations.png "ORIAHNN (COPACKAGED) drug patent expirations")
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ORIAHNN (COPACKAGED)
*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)
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
| 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 | ||||
| >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)
| 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 |
| >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.
| 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 |
| >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.
ISSN: 2162-2639
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