APOTEX

FDA Approved Biologics and Pending Applications

Grastofil

filgrastim
Grastofil Approval Pending

Lapelga

pegfilgrastim
Lapelga Approval Pending

Teriparatide Apotex

teriparatide
ANDA 211097

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Apo-teriparatide (teriparatide) (Apotex) (May-2020)Bambevi® (bevacizumab) (Apobiologix) (September-2021)Grastofil (filgrastim) (Apotex) (December-2015)Lapelga (pegfilgrastim) (Apotex) (April-2018)

Biosimilars Approved In The E.U.

Grastofil (filgrastim) (Apotex) (October-2013)

Inter Partes Review Proceedings

EYLEAIPR2022-00298
IPR2022-00301
IPR2022-01524
NEUPOGEN / NEULASTA / GRASTOFIL / LAPELGAIPR2016-01542
NEUPOGEN / NEULASTA / RELEUKO / GRASTOFIL / LAPELGA / FYLNETRAPGR2019-00001

U.S. Patent Litigations

FORTICAL1:02-cv-08917 (S.D.N.Y.)
1:06-cv-05571 (S.D.N.Y.)
NEULASTA / LAPELGA0:15-cv-61631 (S.D. Fla.)
NEUPOGEN / GRASTOFIL0:15-cv-62081 (S.D. Fla.)
NEUPOGEN / NEULASTA / GRASTOFIL / LAPELGA0:18-cv-61828 (S.D. Fla.)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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