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BLA

PRABOTULINUMTOXINA-XVFS | B761085 | EVOLUS INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

February 1, 2031(1674 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 1, 2031	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 12, 20425792 days remaining

Based on latest discovered patent 11331598(manufacturing) · relevance 92/100

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.

Manufacturing

(1)

92/10011331598Grant: 2022-05-17 | Exp: 2042-05-12

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 761085

351(a) ReferenceLicensedCDERFor Injection

Proper Name

prabotulinumtoxinA-xvfs

Applicant

Evolus Inc.

Approval Date

1-Feb-19

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2019	SUPPL -1	View Letter (PDF)
Feb 13, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100 UNITS

▴

INJECTABLE;INJECTION | Approved: 2019-02-01 00:00:00

No patent or exclusivity listings for this strength.