Defendant

Padagis LLC

1 case as defendant.

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

Company profile

Company overview. Padagis LLC is a private, private-equity-backed generic pharmaceutical company headquartered at 1251 Lincoln Road, Allegan, Michigan. It was founded in 2004 as the U.S. generic-prescription (Rx) business of Perrigo Company plc and became an independent operating company on July 6, 2021, when Altaris Capital Partners, a healthcare-focused New York private equity firm, acquired it from Perrigo for approximately $1.55 billion. Padagis reports 1,300+ employees across six sites in the U.S. and Israel (manufacturing in Minneapolis, Minnesota and Yeruham, Israel). Because it is private, revenue is not publicly disclosed.

Products / operations. Padagis develops, manufactures, and markets generic Rx and OTC medicines, specializing in "extended topical" dosage forms — creams, ointments, lotions, gels, foams, solutions, and nasal sprays — across categories such as dermatology, hormone therapy, and central nervous system/rescue medicines. Its portfolio spans more than 200 product families and roughly 800 SKUs; its best-known product is a generic naloxone HCl nasal spray for opioid-overdose reversal, which it sells OTC and has recently moved to U.S. production. Padagis also operates a contract development and manufacturing (CDMO) business for topical and nasal drug products. It is an operating company with real products and manufacturing — not a non-practicing entity.

Patent-litigation posture. Padagis appears in the database solely as a defendant: 0 plaintiff cases, 1 defendant case, in the District of Delaware. The suit is Neurelis, Inc. v. Padagis LLC et al. (filed May 8, 2024), a Hatch-Waxman/ANDA action in which Padagis is the generic applicant seeking FDA approval to market a copy of Neurelis's Valtoco® (diazepam nasal spray, 10 mg/spray) before the Orange Book patents expire, via Paragraph IV certifications. Delaware is the customary venue for such cases rather than a plaintiff-friendly outlier.

Notable context. Related public filings show Padagis also filed inter partes review petitions (e.g., IPR2025-00464/465/466) challenging the Valtoco patents, and that its subsidiaries (Padagis US LLC, Padagis Israel) have engaged in prior Hatch-Waxman patent litigation, including counterclaims in Delaware. The company's litigation activity reflects its core strategy: first-to-file generic launches that challenge branded pharmaceutical patents.

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.