Viewing data from:

POLIVY

BLA

POLATUZUMAB VEDOTIN-PIIQ | B761121 | GENENTECH

2 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 10, 2031(1679 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 10, 2031	Active	Computed
7-Year Orphan	Apr. 19, 2030	Active	Purple Book

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

Medicare Part B Spending

CMS physician-administered drug spending for Polivy (2024)

Total Spending

$201.5M

Total Claims

10,844

Beneficiaries

3,042

ASP Price

$127.02

Spending Trend

$48.1M(2020)→$42.3M(2021)→$66.2M(2022)→$118.9M(2023)→$201.5M(2024)

YoY Change:+6.2%

5yr CAGR:+3.0%

HCPCS: J9309 — Injection, polatuzumab vedotin-piiq, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Purple Book (Biologics)

BLA 761121 | 2 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

polatuzumab vedotin-piiq

Applicant

Genentech, Inc.

Approval Date

June 10, 2019

Orphan Exclusivity

April 19, 2030

3y 5mo remaining

Presentations

140MG — Single-Dose Vial (Intravenous)

30MG — Single-Dose Vial (Intravenous)

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 20, 2026	SUPPL -17	View Letter (PDF)
Apr 20, 2023	SUPPL -8	View Letter (PDF)
Jan 12, 2021	SUPPL -3	View Letter (PDF)
Jul 3, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 140MG/VIAL

▴

POWDER;INTRAVENOUS | Approved: 2019-06-10 00:00:00

No patent or exclusivity listings for this strength.

#002 — 30MG/VIAL

▾

POWDER;INTRAVENOUS | Approved: 2019-06-10 00:00:00