Viewing data from:

TRASYLOL

BLA

APROTININ | B020304 | BAYER HLTHCARE

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

December 29, 2000(9317 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Dec. 29, 2000	Expired	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

Purple Book (Biologics)

BLA 20304 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

aprotinin

Applicant

Bayer HealthCare Pharmaceuticals Inc.

Approval Date

29-Dec-93

Orphan Exclusivity

29-Dec-00

Expired

1,000,000KIU/100ML (10,000KIU/ML) — Single-Dose Vial (Intravenous)

2,000,000KIU/200ML (10,000KIU/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	SUPPL -22	View Letter (PDF)
Mar 23, 2020	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10,000KIU/ML

▴

INJECTABLE;INJECTION | Approved: 1993-12-29 00:00:00

No patent or exclusivity listings for this strength.