ALLERGAN

ALLERGAN

approved_indications FDA Approved Biologics and Pending Applications


Botox®

onabotulinumtoxinA
BL 103000

Kanjinti®

trastuzumab-anns
aBL 761073

Mvasi®

bevacizumab-awwb
aBL 761028

Riabni

rituximab-arrx
aBL 761140

Viokace®

pancrelipase (amylase; lipase; protease)
BL 022542

Zenpep®

pancrelipase (amylase; lipase; protease)
BL 022210

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Kanjinti® (trastuzumab) (Amgen) (February-2020)Mvasi® (bevacizumab) (Amgen) (October-2018)

Biosimilars Approved In The E.U.

Kanjinti® (trastuzumab) (Amgen / Allergan) (May-2018)Mvasi® (bevacizumab) (Amgen/Allergan) (January-2018)

Biosimilars Approved In Australia

Kanjinti® (trastuzumab) (Amgen) (May-2019)

approved_indications Inter Partes Review Proceedings


BOTOXIPR2015-01119
IPR2016-00102
IPR2021-01203
IPR2021-01204
PGR2019-00062
BOTOX / DAXXIFYIPR2021-01203
IPR2021-01204
DYSPORT / BOTOXIPR2015-01119
PGR2019-00062

approved_indications U.S. Patent Litigations


BOTOX1:15-cv-03372 (N.D. Ill.)
1:21-cv-01411 (D. Del.)
BOTOX / DAXXIFY1:21-cv-01411 (D. Del.)

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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