ABBVIE

FDA Approved Biologics and Pending Applications

Botox®

onabotulinumtoxinA
BL 103000

Creon®

pancrelipase (amylase; lipase; protease)
BL 020725

Humira®

adalimumab
BL 125057

Skyrizi®

risankizumab-rzaa
BL 761105 [BL 761262]

Survanta®

beractant
BL 020032

Inter Partes Review Proceedings

BOTOX / DAXXIFYIPR2021-01203
IPR2021-01204
DYSPORT / BOTOXPGR2019-00062
HUMIRA / AMJEVITAIPR2015-01514
IPR2015-01517
HUMIRA / CYLTEZOIPR2016-00408
IPR2016-00409
HUMIRA / HYRIMOZIPR2017-01823
IPR2017-01824
IPR2017-01987
IPR2017-01988
IPR2017-02105
IPR2017-02106
IPR2018-00002
IPR2018-00156
HUMIRA / YUSIMRYIPR2016-00172
IPR2016-00188
IPR2016-00189
IPR2016-01018
IPR2017-00822
IPR2017-00823
IPR2017-00826 / IPR2017-01008
IPR2017-00827 / IPR2017-01009

U.S. Patent Litigations

HUMIRA1:11-cv-02541 (S.D.N.Y.)
1:16-cv-00666 (D. Del.)
1:17-cv-01065 (D. Del.)
1:21-cv-02258 (N.D. Ill.)
1:21-cv-02899 (N.D. Ill.)
1:21-cv-05645 (N.D. Ill.) (transferred from 2:21-cv-00265 (E.D. Va.))
2:16-cv-00322 (E.D. Va.)
3:18-cv-12668 (D.N.J.)
SIMPONI4:09-cv-40089 (D. Mass.)
STELARA4:09-cv-11340 (D. Mass.)
HUMIRA / AMJEVITA1:16-cv-00666 (D. Del.)
HUMIRA / CYLTEZO1:17-cv-01065 (D. Del.)
HUMIRA / HYRIMOZ3:18-cv-12668 (D.N.J.)
HUMIRA / SIMLANDI1:21-cv-02258 (N.D. Ill.)
1:21-cv-02899 (N.D. Ill.)
1:21-cv-05645 (N.D. Ill.) (transferred from 2:21-cv-00265 (E.D. Va.))

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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