RINVOQ Drug Patent Profile

When do Rinvoq patents expire, and when can generic versions of Rinvoq launch?

Rinvoq is a drug marketed by Abbvie and is included in two NDAs. There are forty-five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-three patent family members in forty-one countries.

The generic ingredient in RINVOQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Rinvoq

Rinvoq was eligible for patent challenges on August 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2036. This may change due to patent challenges or generic licensing.

There have been seven 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.

There are two tentative approvals for the generic drug (upadacitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for RINVOQ

International Patents:	233
US Patents:	45
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	42
Patent Applications:	1,205
Drug Prices:	Drug price information for RINVOQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RINVOQ
What excipients (inactive ingredients) are in RINVOQ?	RINVOQ excipients list
DailyMed Link:	RINVOQ at DailyMed

See drug prices for RINVOQ

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

Constraining patent/regulatory exclusivity:

9,951,080

NDA:

211675

Dosage:

TABLET, EXTENDED RELEASE;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 RINVOQ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Berinstein, Jeffrey	PHASE4
AbbVie	PHASE4
AbbVie	PHASE3

See all RINVOQ clinical trials

Pharmacology for RINVOQ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for RINVOQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RINVOQ	Extended-release Tablets	upadacitinib	45 mg	211675	3	2023-08-16

US Patents and Regulatory Information for RINVOQ

RINVOQ is protected by sixty-one US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,951,080.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No	11,718,627		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes	10,202,393		Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	RE47221			Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	9,951,080		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for RINVOQ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Rinvoq	upadacitinib	EMEA/H/C/004760Rheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.	Authorised	no	no	no	2019-12-16

International Patents for RINVOQ

When does loss-of-exclusivity occur for RINVOQ?

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

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

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 RINVOQ around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016340167
Australia	2020359635
Australia	2021236570
Australia	2023251492
Australia	2024240383
Australia	2025205010

Supplementary Protection Certificates for RINVOQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	CA 2020 00011	Denmark		PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716	301035	Netherlands		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1404 20191218
2506716	122020000011	Germany		PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716	LUC00149	Luxembourg		PRODUCT NAME: UPADACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716	PA2020505	Lithuania		PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716	2020C/505	Belgium		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218

DrugChatter Q&A for RINVOQ

Abbvie rinvoq ulcerative colitis?
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Rinvoq patent expiration 2032?