Viewing data from:

KALETRA

NDA

LOPINAVIR; RITONAVIR | N021226 | ABBVIE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Cipla Limited et al 1:2017cv01631 9 patentsANDA 090-371lopinavir/ritonavir	D. Del.	2017-11-10	Terminated 2018-04-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Kaletra (2023)

Total Spending

$498K

Total Claims

430

Beneficiaries

101

Avg Cost/Unit

$8.66

Spending Trend

$19.8M(2019)→$14.6M(2020)→$9.1M(2021)→$2.3M(2022)→$498K(2023)

YoY Change:-3.1%

5yr CAGR:-0.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

26 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 133.3MG;33.3MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 15, 2000

No patent or exclusivity listings for this strength.