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KALETRA

NDA

LOPINAVIR; RITONAVIR | N021251 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

39 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2020	SUPPL -59	View Letter (PDF)
Dec 23, 2019	SUPPL -58	View Letter (PDF)
Aug 22, 2019	SUPPL -57	View Letter (PDF)
Dec 7, 2018	SUPPL -56	View Letter (PDF)
Oct 18, 2017	SUPPL -55	View Letter (PDF)
Jun 16, 2017	SUPPL -54	View Letter (PDF)
Nov 23, 2016	SUPPL -52	View Letter (PDF)
Sep 20, 2016	SUPPL -53	View Letter (PDF)
Nov 17, 2015	SUPPL -51	View Letter (PDF)
Jul 6, 2015	SUPPL -49	View Letter (PDF)
Apr 1, 2015	SUPPL -50	View Letter (PDF)
Jan 29, 2015	SUPPL -47	View Letter (PDF)
Nov 8, 2013	SUPPL -46	View Letter (PDF)
Jan 22, 2013	SUPPL -45	View Letter (PDF)
May 18, 2012	SUPPL -44	View Letter (PDF)
Apr 24, 2012	SUPPL -41	View Letter (PDF)
Feb 27, 2012	SUPPL -42	View Letter (PDF)
May 10, 2011	SUPPL -40	View Letter (PDF)
Mar 1, 2011	SUPPL -39	View Letter (PDF)
Jun 16, 2010	SUPPL -33	View Letter (PDF)
May 3, 2010	SUPPL -31	View Letter (PDF)
Feb 5, 2010	SUPPL -29	View Letter (PDF)
Apr 24, 2009	SUPPL -26	View Letter (PDF)
Apr 10, 2009	SUPPL -23	View Letter (PDF)
Oct 8, 2008	SUPPL -24	View Letter (PDF)
Aug 5, 2008	SUPPL -17	View Letter (PDF)
Jun 24, 2008	SUPPL -22	View Letter (PDF)
Nov 19, 2007	SUPPL -18	View Letter (PDF)
Oct 4, 2007	SUPPL -19	View Letter (PDF)
Jul 5, 2007	SUPPL -16	View Letter (PDF)
Apr 25, 2007	SUPPL -12	View Letter (PDF)
Mar 7, 2007	SUPPL -14	View Letter (PDF)
Jan 8, 2007	SUPPL -13	View Letter (PDF)
Mar 30, 2005	SUPPL -11	View Letter (PDF)
Oct 26, 2004	SUPPL -10	View Letter (PDF)
Dec 8, 2003	SUPPL -9	View Letter (PDF)
Jan 18, 2002	SUPPL -4	View Letter (PDF)
Mar 13, 2001	SUPPL -2	View Letter (PDF)
Sep 15, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG/ML;20MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 15, 2000

No patent or exclusivity listings for this strength.