Fourth-Quarter and Full-Year 2019 Orphan and Rheumatology Segment Results
Our Portfolio Is Supported by Our Intellectual Property Expertise
KRYSTEXXA
pegloticase
•
Orphan
18 U.S. patents extending to 2030; composition of matter to 2026
Biologic Exclusivity to 2022
PENNSAID
(diclofenac sodium topical solution) 2% w/w
•
Inflammation
Settled Teligent, Amneal, Paddock (Perrigo), Taro and Lupin
litigations by granting a right to market no sooner than
Oct. 17, 2027
⚫ In May 2017, U.S. District Court upheld '913 patent (extends
to 2027) in case against Actavis
TEPEZZA™
teprotumumab-trbw
RAVICTI®
(glycerol phenylbutyrate)OralLiquid
12-HOUR
PROCYSBI
(cysteamine bitartrate)
delayed-release capsules
Orphan Drug Exclusivity: U.S. 2020-2027
Biologic Exclusivity to 2032
Settled Par (first-filer) litigation with right to market
July 1, 2025
Settled Lupin litigation with right to market 180 days after Par
9 OB-listed patents extending to 2036
Orphan Drug Exclusivity: U.S. 2020-2022
DUEXIS®
(ibuprofen and famotidine) Tablets
800 mg/26.6 mg
RAYOSⓇ
(Prednisone) Delayed-release Tablets
ACTIMMUNE
(Interferon gamma-1b)
2 U.S. patents extending to 2022
HORIZON
•
•
Settled Par (first-filer) litigation with right to market Jan. 1, 2023
Settled Actavis (first-filer) litigation with right to market
Dec. 23, 2022
VIMOVO
(naproxen/esomeprazole magnesium)
On-going litigation with Dr. Reddy's Laboratories
Although Dr. Reddy's Laboratories received FDA approval of its
ANDA in February 2020, a launch while patent litigation is
ongoing constitutes an at-risk launch
⚫ Settled litigation with the following parties: Mylan, Actavis and
Lupin with right to market Aug. 1, 2024
39View entire presentation