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PULMOTECH MAA

BLA

TECHNETIUM TC99M ALBUMIN AGGREGATED | B210089 | CIS BIO INTL

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 20, 2032(2087 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 20, 2032	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 210089

351(a) ReferenceLicensedCDERFor Injectable Suspension

Proper Name

kit for the preparation of technetium Tc-99m albumin aggregated

Applicant

Cis Bio International

Approval Date

20-Mar-20

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2023	SUPPL -2	View Letter (PDF)
Mar 24, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG

▴

INJECTABLE;INJECTION | Approved: 2020-03-20 00:00:00

No patent or exclusivity listings for this strength.