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BLA

TAFASITAMAB-CXIX | B761163 | MORPHOSYS US INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

July 31, 2032(2220 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 31, 2032	Active	Computed
7-Year Orphan	Jul. 31, 2027	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

Purple Book (Biologics)

BLA 761163

351(a) ReferenceLicensedCDERFor Injection

Proper Name

tafasitamab-cxix

Applicant

Incyte Corporation

Approval Date

31-Jul-20

Orphan Exclusivity

31-Jul-27

1y remaining

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 12MG/KG

▴

SOLUTION;INTRAVENOUS | Approved: 2020-07-31 00:00:00

No patent or exclusivity listings for this strength.