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BLA

GARETOSMAB-GRTS | B761508 | REGENERON PHARMACEUTICALS, INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 19, 2038(4306 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 19, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761508

351(a) ReferenceLicensedCDERInjection

Proper Name

garetosmab-grts

Applicant

Regeneron Pharmaceuticals, Inc.

Approval Date

August 19, 2026

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/5ML

▴

INJECTABLE;INTRAVENOUS | Approved: 2026-08-19 00:00:00

No patent or exclusivity listings for this strength.