Elevidys® (delandistrogene moxeparvovec-rokl)

BL 125781

Elevidys® (delandistrogene moxeparvovec-rokl)

BL 125781

U.S. License Holder:

Sarepta Therapeutics

Date of License:

June-22-2023

Last Update:

May-15-2026

approved_indications FDA-Approved Indications

ELEVIDYS (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated in individuals at least 4 years of age:

For the treatment of Duchenne muscular dystrophy (DMD) in patients who are ambulatory and have a confirmed mutation in the DMD gene;

For the treatment of DMD in patients who are non-ambulatory and have a confirmed mutation in the DMD gene.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2024-00580

U.S. Patent No.
11,680,274 (Method of Increasing the Function of an AAV Vector)

Patent Owner
Trustees of the University of Pennsylvania; REGENXBIO Inc.

Petitioner(s)
Sarepta Therapeutics, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3-6, 8

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Claims 1, 3-6 Disclaimed After Institution)

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
26-1071

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Claims 1, 3-6 Disclaimed After Institution. Federal Circuit Appeal Pending

IPR2025-01194

U.S. Patent No.
9,051,542 (Compositions and Methods to Prevent AAV Vector Aggregation)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 3-6

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted (Summarily Denied by USPTO Director)

IPR2025-01195

U.S. Patent No.
7,704,721 (Compositions and Methods to Prevent AAV Vector Aggregation)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-4, 6-7, 11

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted (Summarily Denied by USPTO Director)

IPR2026-00149

U.S. Patent No.
12,013,326 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-5, 7-9, 12-23, 25-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted (Summarily Denied by USPTO Director)

IPR2026-00150

U.S. Patent No.
12,031,894 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-7, 10-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2026-00166

U.S. Patent No.
12,298,313 (Methods for Detecting AAV)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-27

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision)

IPR Status
Terminated Prior to Institution Decision - Withdrawn for Premature Filing, Refiled as IPR2026-00270

IPR2026-00167

U.S. Patent No.
11,698,377 (Methods for Detecting AAV)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-20

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted (Summarily Denied by USPTO Director)

IPR2026-00168

U.S. Patent No.
12,123,880 (Methods for Detecting AAV)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-21

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted (Summarily Denied by USPTO Director)

IPR2026-00270

U.S. Patent No.
12,298,313 (Methods for Detecting AAV)

Patent Owner
Genzyme Corp.

Petitioner(s)
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-27

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:19-cv-02316 (D. Del.)

U.S. Patent Nos.
8,697,443 (Cell Culture Methods and Devices Utilizing Gas Permeable Materials) 9,441,192 (Cell Culture Methods and Devices Utilizing Gas Permeable Materials)

Plaintiffs
Wilson Wolf Manufacturing Corporation

Defendants
Sarepta Therapeutics, Inc.

Status
Stipulated Dismissal

BPCIA
N

1:20-cv-01226 (D. Del.)

U.S. Patent Nos.
10,526,617 (Method of Detecting and/or Identifying Adeno-Associated Virus (AAV) Sequences and Isolating Novel Sequences Identified Thereby)

Plaintiffs
REGENXBIO Inc.; Trustees of the University of Pennsylvania

Defendants
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

Federal Circuit Appeal(s)
24-1408

Status
Summary Judgment: Patent Invalid- Ineligible Subject Matter under Section 101; Federal Circuit Reversed and Remanded, En Banc and Panel Rehearing Denied, Remand Pending

BPCIA
N

1:23-cv-00667 (D. Del.)

U.S. Patent Nos.
11,680,274 (Method of Increasing the Function of an AAV Vector)

Plaintiffs
REGENXBIO Inc.; Trustees of the University of Pennsylvania

Defendants
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

Status
Stayed Pending IPR2024-00580

BPCIA
N

1:24-cv-00882 (D. Del.)

U.S. Patent Nos.
7,704,721 (Compositions and Methods to Prevent AAV Vector Aggregation) 9,051,542 (Compositions and Methods to Prevent AAV Vector Aggregation) 11,698,377 (Methods for Detecting AAV) 12,013,326 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles) 12,031,894 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles) 12,123,880 (Methods for Detecting AAV) 12,298,313 (Methods for Detecting AAV)

Plaintiffs
Genzyme Corporation

Defendants
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC

Status
Case Ongoing

BPCIA
N

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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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