orilissa Drug Patent Profile
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When do Orilissa patents expire, and what generic alternatives are available?
Orilissa is a drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and one patent family members in twenty-six countries.
The generic ingredient in ORILISSA is elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Orilissa
Orilissa 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 three 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
Summary for orilissa
| International Patents: | 101 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 5 |
| Patent Applications: | 184 |
| Drug Prices: | Drug price information for orilissa |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for orilissa |
| What excipients (inactive ingredients) are in orilissa? | orilissa excipients list |
| DailyMed Link: | orilissa at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for orilissa
Generic Entry Date for orilissa*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.
Recent Clinical Trials for orilissa
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Phase 2 |
| University of North Carolina, Chapel Hill | Phase 2 |
| Stanford University | Phase 2 |
Pharmacology for orilissa
| Drug Class | Gonadotropin Releasing Hormone Receptor Antagonist |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors |
| Physiological Effect | Decreased GnRH Secretion |
Anatomical Therapeutic Chemical (ATC) Classes for orilissa
Paragraph IV (Patent) Challenges for ORILISSA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ORILISSA | Tablets | elagolix sodium | 150 mg and 200 mg | 210450 | 9 | 2022-07-25 |
US Patents and Regulatory Information for orilissa
orilissa is protected by eleven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of orilissa 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 orilissa
Methods of administering elagolix
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN
Methods of administering elagolix
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE
Methods of treating heavy menstrual bleeding
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN TO REDUCE DYSMENORRHEA AND NON-MENSTRUAL PELVIC PAIN
Methods of treating heavy menstrual bleeding
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN HAVING DYSPAREUNIA ASSOCIATED WITH ENDOMETRIOSIS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN A PATIENT WITH MODERATE HEPATIC IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS
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 relating thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | 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 orilissa
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-001 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450-002 | Jul 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for orilissa
See the table below for patents covering orilissa around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Try a Trial |
| China | 112469417 | 恶拉戈利钠组合物和方法 (ELAGOLIX SODIUM COMPOSITIONS AND PROCESSES) | ⤷ Try a Trial |
| Israel | 272682 | פורמולציות רוקחיות מוצקות לטיפול באנדומטריוסיס, פיברואידים ברחם וסינדרום שחלות פוליציסטיות ואדנומיוזיס (Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis) | ⤷ Try a Trial |
| Canada | 2398018 | ANTAGONISTES DU RECEPTEUR DE LA GONADOLIBERINE ET METHODES ASSOCIEES (GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS AND METHODS RELATING THERETO) | ⤷ Try a Trial |
| Brazil | 112020003380 | formulações farmacêuticas para o tratamento de endometriose, miomas uterinos, síndrome do ovário policístico ou adenomiose | ⤷ Try a Trial |
| Singapore | 11202001439Q | SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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