Defendant

Padagis Israel Pharmaceuticals Ltd.

1 case as defendant.

Cases
1
Active
1
0 closed
Filed
2024
Top venue
D. Delaware
1 case

Company profile

Company overview. Padagis Israel Pharmaceuticals Ltd. (formerly Perrigo Israel Pharmaceuticals Ltd., and earlier Agis Industries) is an Israeli generic-drug manufacturer headquartered at 1 Rakefet Street, Shoham, Israel, with manufacturing plants in Shoham and Yeruham. It is a wholly owned subsidiary of Padagis LLC, the Delaware-based generic prescription business that Altaris Capital Partners acquired from Perrigo Company plc in July 2021 for $1.55 billion. The Padagis group is private and employs roughly 1,300 people across six U.S. and Israeli sites; a standalone employee or revenue figure for the Israeli entity is not publicly disclosed.

Products / operations. Padagis Israel develops, manufactures, and markets generic prescription pharmaceuticals for the U.S. and Israeli markets, specializing in complex extended-topical and non-oral dosage forms — creams, ointments, gels, foams, liquids, and nasal sprays — including hormone and dermatology products. It is an FDA-registered finished-dose manufacturer (with EMA GMP certification) whose U.S.-marketed ANDA products include hydrocortisone, ketoconazole foam, fluocinolone ear drops, budesonide rectal foam, podofilox gel, and naloxone nasal spray. It also imports and distributes third-party branded pharmaceuticals and diagnostic products in Israel.

Patent-litigation posture. Padagis Israel is an operating company, not an NPE. Its single tracked appearance is as a defendant: Neurelis, Inc. v. Padagis LLC et al. (D. Del., filed May 8, 2024). This is a Hatch-Waxman ANDA suit in which Neurelis, holder of the NDA for Valtoco (diazepam nasal spray), alleges that Padagis's Paragraph IV ANDA filing for a generic version infringes several formulation patents. Such suits arise from Padagis's ordinary business of challenging brand patents to launch generics; consistent with that role, the company has also filed inter partes review petitions against the patents at issue.

Notable context. The Delaware litigation involves Padagis Israel together with affiliates Padagis LLC and Padagis US, which the complaint describes as a unitary generic business. Related follow-on suits and IPR petitions concerning the same diazepam nasal-spray ANDA have continued through 2025–2026. The venue (Delaware) is typical for ANDA litigation rather than an NPE forum choice.

Neurelis, Inc. v. Padagis LLC et al.

pending
Docket:
1:24-cv-00562-MN
Filed:
2024-05-08

ANDA/Hatch-Waxman litigation over Padagis ANDA No. 219320 for generic diazepam nasal spray. It is the lead consolidated action and asserts the '414 patent along with related family patents. Trial is scheduled as a bench trial beginning March 1, 2027.