Hyrimoz® — Venable's BiologicsHQ

U.S. License Holder:

Sandoz Inc.

Date of License:

October-30-2018 (Low Concentration); March-20-2023 (High Concentration); May-13-2024 (Interchangeabl

Last Update:

Nov-15-2024

FDA-Approved Indications

HYRIMOZ (adalimumab-adaz) is a tumor necrosis factor (TNF)-blocker indicated for:

Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA;

Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older;

Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA;

Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS;

Crohn’s Disease (CD): Treatment of moderately to severely active Crohn's Disease in adult and pediatric patients 6 years of age and older;

Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients;

Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate;

Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients;

Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Hyrimoz® (Sandoz Canada) (November-2020)

Biosimilars Approved In The E.U.

Hyrimoz® (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)

Biosimilars Approved In Australia

Hyrimoz® (Sandoz) (May-2019)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2017-01823

U.S. Patent No.
8,802,100 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-29

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01824

U.S. Patent No.
9,512,216 (Use of TNF-Alpha Inhibitor)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-16

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Federal Circuit Appeal(s)
18-2142

IPR Status
IPR Not Instituted; Request for Rehearing Denied; Federal Circuit Appeal Voluntarily Dismissed

IPR2017-01987

U.S. Patent No.
8,911,737 (Methods of Administering Anti-TNF Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.; Abbott Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled while Request for Rehearing of Decision Denying Institution was Pending)

IPR Status
IPR Not Instituted; Request for Rehearing Terminated Due to Settlement

IPR2017-01988

U.S. Patent No.
8,974,790 (Methods of Administering Anti-TNF Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.; Abbott Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled while Request for Rehearing of Decision Denying Institution was Pending)

IPR Status
IPR Not Instituted; Request for Rehearing Terminated Due to Settlement

IPR2017-02105

U.S. Patent No.
9,090,689 (Use of TNF-Alpha Inhibitor for Treatment of Psoriasis)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 4, 7, 10, 13, 16, 19

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2017-02106

U.S. Patent No.
9,067,992 (Use of TNF-Alpha Inhibitor for Treatment of Psoriatic Arthritis)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
Y: Claims 1, 5, 6

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 2, 5-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2018-00002

U.S. Patent No.
9,512,216 (Use of TNF-Alpha Inhibitor)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-16

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Federal Circuit Appeal(s)
18-2143 (Consolidated with lead appeal 18-2142)

IPR Status
IPR Not Instituted; Federal Circuit Appeal Voluntarily Dismissed

IPR2018-00156

U.S. Patent No.
9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent Litigations

PACER

Case No(s):

3:18-cv-12668 (D.N.J.)

U.S. Patent Nos.
9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,750,808 (Formulation of Human Antibodies for Treating TNF-alpha Associated Disorders)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Status
Dismissed due to Settlement

BPCIA
Y

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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Hyrimoz® (adalimumab-adaz)

Hyrimoz® (adalimumab-adaz)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Inter Partes Review Proceedings

IPR Case No(s):

IPR2017-01823

IPR2017-01824

IPR2017-01987

IPR2017-01988

IPR2017-02105

IPR2017-02106

IPR2018-00002

IPR2018-00156

U.S. Patent Litigations

Case No(s):

3:18-cv-12668 (D.N.J.)

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