Dupixent® — Venable's BiologicsHQ

U.S. License Holder:

Regeneron Pharmaceuticals

Date of License:

March-28-2017

Last Update:

June-30-2025

FDA-Approved Indications

DUPIXENT (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

Atopic Dermatitis: For the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids;

Asthma: As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma;

Chronic Rhinosinusitis with Nasal Polyposis: As an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP);

Eosinophilic Esophagitis: For the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE);

Prurigo Nodularis: For the treatment of adult patients with prurigo nodularis (PN);

Chronic Obstructive Pulmonary Disease: As an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype;

Chronic Spontaneous Urticaria: For the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2017-01129

U.S. Patent No.
8,679,487 (Anti-interleukin-4 receptor antibodies)

Patent Owner
Immunex Corp.

Petitioner(s)
Genzyme Corp.; Regeneron Pharmaceuticals, Inc.; Sanofi-Aventis US LLC

§ 102 Challenge
Y: Claims 1-17

Claim Types Challenged Under § 102
Composition of Matter Formulation (Pharmaceutical Composition) Other (Kit)

§ 102 Challenge Instituted
N

§ 103 challenge
N

IPR Status
IPR Not Instituted

IPR2017-01879

U.S. Patent No.
8,679,487 (Anti-interleukin-4 receptor antibodies)

Patent Owner
Immunex Corp.

Petitioner(s)
Aventisub LLC; Genzyme Corp.; Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC

§ 102 Challenge
Y: Claims 1-14, 16, 17

Claim Types Challenged Under § 102
Composition of Matter Formulation (Pharmaceutical Composition) Other (Kit)

§ 102 Challenge Instituted
Y

§ 103 challenge
N

Federal Circuit Appeal(s)
19-1777 (condolidated with lead appeal 17-1749)

Supreme Court Appeal(s)
20-1285

IPR Status
Final Written Decision (No Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed; Writ of Certiorari Denied

IPR2017-01884

U.S. Patent No.
8,679,487 (Anti-interleukin-4 receptor antibodies)

Patent Owner
Immunex Corp.

Petitioner(s)
Aventisub LLC; Genzyme Corp.; Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-17

Claim Types Challenged Under § 103
Composition of Matter Formulation (Pharmaceutical Composition) Other (Kit)

§ 103 Challenge Instituted
Y

Federal Circuit Appeal(s)
19-1749 (lead appeal, consolidated with 19-1777)

Supreme Court Appeal(s)
20-1285

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed; Writ of Certiorari Denied

U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-10465 (D. Mass.)

U.S. Patent Nos.
8,679,487 (Anti-Interleukin-4 Receptor Antibodies)

Plaintiffs
Sanofi-Aventis U.S. LLC; Genzyme Corp.; Regeneron Pharmaceuticals, Inc.

Defendants
Amgen Inc.; Immunex Corp.

Status
Dismissed

BPCIA
N

2:17-cv-02613 (C.D. Cal.)

U.S. Patent Nos.
8,679,487 (Anti-Interleukin-4 Receptor Antibodies)

Plaintiffs
Sanofi; Sanofi-Aventis U.S. LLC; Genzyme Corp.; Aventisub LLC; Regeneron Pharmaceuticals, Inc.

Defendants
Immunex Corp.; Amgen Inc. (Interested party)

Status
Case Ongoing

BPCIA
N

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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Dupixent® (dupilumab)

Dupixent® (dupilumab)

FDA-Approved Indications

Inter Partes Review Proceedings

IPR Case No(s):

IPR2017-01129

IPR2017-01879

IPR2017-01884

U.S. Patent Litigations

Case No(s):

1:17-cv-10465 (D. Mass.)

2:17-cv-02613 (C.D. Cal.)

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