APOTEX

APOTEX

approved_indications FDA Approved Biologics and Pending Applications


Grastofil

filgrastim
Grastofil Approval Pending

Lapelga

pegfilgrastim
Lapelga Approval Pending

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

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

approved_indications Inter Partes Review Proceedings


NEUPOGEN / NEULASTA / GRASTOFILIPR2016-01542
NEUPOGEN / NEULASTA / TPI G-CSF / GRASTOFILPGR2019-00001

approved_indications 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.)

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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