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BLA

VELMANASE ALFA-TYCV | B761278 | CHIESI FARMACEUTICI SPA

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

February 16, 2035(3150 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 16, 2035	Active	Computed
7-Year Orphan	Feb. 16, 1930	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 30, 20446541 days remaining

Based on latest discovered patent 11998643(formulation) · relevance 87/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 1 patents →

1 AI-discovered patents, sorted by relevance.

Formulation

(1)

87/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

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 761278

351(a) ReferenceLicensedCDERFor Injection

Proper Name

velmanase alfa-tycv

Applicant

Chiesi Farmaceutici S.p.A.

Approval Date

16-Feb-23

Orphan Exclusivity

16-Feb-30

Expired

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 17, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

▴

POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | Approved: 2023-02-16 00:00:00

No patent or exclusivity listings for this strength.