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VIRACEPT

NDA

NELFINAVIR MESYLATE | N020779 | AGOURON PHARMACEUTICALS LLC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

127 trials from ClinicalTrials.gov — 1 recruiting, 102 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery NCT04169763	Phase 1	Recruiting	M.D. Anderson Cancer Center	25	2020-08-07 → 2026-12-31
Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma NCT03829020	Phase 1	Completed	Mayo Clinic	9	2019-04-17 → 2023-11-24
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy NCT00006190	Phase 4	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	—	2000-11 → 2001-11
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection NCT00002177	N/A	Completed	Bristol-Myers Squibb	—	1997-05 → 2000-03
A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive NCT00002215	N/A	Completed	Triangle Pharmaceuticals	—	—
Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers NCT00005762	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	90	2001-03 → 2004-05
Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV NCT00006441	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	398	2003-02 → 2008-10
A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma NCT01020292	Phase 1	Completed	Abramson Cancer Center at Penn Medicine	31	2009-04 → 2017-12
Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma NCT02188537	Phase 2	Completed	Swiss Cancer Institute	34	2014-12-02 → 2018-04-17
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients NCT00002374	Phase 3	Completed	Hoffmann-La Roche	120	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$908.73

Highest Price

$1195.70

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63010-0010-30VIRACEPT 250MG TAB	$1195.70	FSS	Pfizer Inc.	06/30/2029
63010-0010-30VIRACEPT 250MG TAB	$908.73	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain0 active DMFs3 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

GANES CHEMICALS INC PENNSVILLE DIVInactiveNELFINAVIR

DMF 121781996

MYLAN LABORATORIES LTDInactiveNELFINAVIR MESYLATE

DMF 185002005

AUROBINDO PHARMA LTDInactiveNELFINAVIR MESYLATE

DMF 184542005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Mar 25, 2021	SUPPL -63	View Letter (PDF)
Sep 22, 2016	SUPPL -62	View Letter (PDF)
Mar 31, 2015	SUPPL -61	View Letter (PDF)
May 31, 2013	SUPPL -59	View Letter (PDF)
Apr 11, 2012	SUPPL -57	View Letter (PDF)
Feb 27, 2012	SUPPL -58	View Letter (PDF)
Feb 28, 2011	SUPPL -56	View Letter (PDF)
Apr 28, 2010	SUPPL -54	View Letter (PDF)
Apr 28, 2010	SUPPL -55	View Letter (PDF)
Nov 26, 2008	SUPPL -53	View Letter (PDF)
Feb 14, 2008	SUPPL -50	View Letter (PDF)
Jan 8, 2007	SUPPL -46	View Letter (PDF)
Oct 20, 2005	SUPPL -45	View Letter (PDF)
Jun 7, 2004	SUPPL -44	View Letter (PDF)
Mar 24, 2004	SUPPL -42	View Letter (PDF)
Aug 29, 2003	SUPPL -41	View Letter (PDF)
Jul 30, 2003	SUPPL -39	View Letter (PDF)
Apr 30, 2003	SUPPL -22	View Letter (PDF)
Apr 30, 2003	SUPPL -11	View Letter (PDF)
Feb 5, 2002	SUPPL -37	View Letter (PDF)
Feb 5, 2002	SUPPL -38	View Letter (PDF)
Apr 11, 2001	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 250MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 14, 1997

No patent or exclusivity listings for this strength.