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KALETRA (LOPINAVIR; RITONAVIR) | LOERadar

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KALETRA

NDA

LOPINAVIR; RITONAVIR | N021906 | ABBVIE INC

2 strengths0 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. Hetero USA Inc. et al 1:2015cv00889 11 patentsANDA 205741lopinavir/ritonavir	D. Del.	2015-10-02	Terminated 2015-10-27	—

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

Approval Letters

33 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2020	SUPPL -54	View Letter (PDF)
Dec 23, 2019	SUPPL -53	View Letter (PDF)
Aug 22, 2019	SUPPL -52	View Letter (PDF)
Dec 7, 2018	SUPPL -51	View Letter (PDF)
Oct 18, 2017	SUPPL -50	View Letter (PDF)
Jun 16, 2017	SUPPL -49	View Letter (PDF)
Nov 23, 2016	SUPPL -46	View Letter (PDF)
Sep 20, 2016	SUPPL -47	View Letter (PDF)
Nov 17, 2015	SUPPL -44	View Letter (PDF)
Jul 6, 2015	SUPPL -42	View Letter (PDF)
Apr 1, 2015	SUPPL -43	View Letter (PDF)
Jan 29, 2015	SUPPL -40	View Letter (PDF)
Nov 8, 2013	SUPPL -39	View Letter (PDF)
Jan 22, 2013	SUPPL -38	View Letter (PDF)
May 18, 2012	SUPPL -36	View Letter (PDF)
Apr 24, 2012	SUPPL -34	View Letter (PDF)
Feb 27, 2012	SUPPL -35	View Letter (PDF)
May 10, 2011	SUPPL -33	View Letter (PDF)
Mar 1, 2011	SUPPL -32	View Letter (PDF)
Jun 16, 2010	SUPPL -26	View Letter (PDF)
May 3, 2010	SUPPL -24	View Letter (PDF)
Feb 5, 2010	SUPPL -22	View Letter (PDF)
Apr 24, 2009	SUPPL -17	View Letter (PDF)
Apr 10, 2009	SUPPL -14	View Letter (PDF)
Oct 8, 2008	SUPPL -15	View Letter (PDF)
Jun 24, 2008	SUPPL -13	View Letter (PDF)
Nov 19, 2007	SUPPL -7	View Letter (PDF)
Oct 4, 2007	SUPPL -8	View Letter (PDF)
Jul 5, 2007	SUPPL -5	View Letter (PDF)
Apr 25, 2007	SUPPL -2	View Letter (PDF)
Mar 7, 2007	SUPPL -4	View Letter (PDF)
Jan 8, 2007	SUPPL -3	View Letter (PDF)
Nov 1, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG;50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 28, 2005

No patent or exclusivity listings for this strength.

#002 — 100MG;25MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 9, 2007