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APTIVUS

NDA

TIPRANAVIR | N021814 | BOEHRINGER INGELHEIM PHARMACEUTICALS 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

49 trials from ClinicalTrials.gov, 40 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.NCT00933205	—	APPROVED_FOR_MARKETING	Boehringer Ingelheim	—	2004-05
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection NCT00062660	—	APPROVED_FOR_MARKETING	Boehringer Ingelheim	—	2003-05 → 2014-04
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection NCT00097799	—	APPROVED_FOR_MARKETING	Boehringer Ingelheim	—	2004-12
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects NCT00146328	Phase 2/3	Completed	Boehringer Ingelheim	997	2001-04
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients NCT00530920	Phase 2	Completed	Boehringer Ingelheim	85	2007-10
Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy Volunteers NCT02245269	Phase 1	Completed	Boehringer Ingelheim	23	2003-07
Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV NCT00307502	Phase 1	Completed	Germans Trias i Pujol Hospital	675	2005-01 → 2009-12
Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects NCT02251795	Phase 1	Completed	Boehringer Ingelheim	52	2007-08
Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers NCT02244190	Phase 1	Completed	Boehringer Ingelheim	32	2008-04
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals NCT00034866	Phase 2	Completed	Boehringer Ingelheim	165	2002-04 → 2002-10

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

VA Federal Supply Schedule

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

Lowest Price

$1563.27

Highest Price

$2073.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0003-02APTIVUS 250MG CAP	$2073.85	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0003-02APTIVUS 250MG CAP	$1563.27	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Aptivus (2024)

Total Spending

$1.1M

Total Claims

500

Beneficiaries

Avg Cost/Unit

$17.28

Spending Trend

$2.2M(2019)→$2.0M(2020)→$1.7M(2021)→$1.4M(2022)→$1.3M(2023)→$1.1M(2024)

YoY Change:-2.4%

5yr CAGR:+3.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain0 active DMFs2 inactive

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

CATALENT PHARMA SOLUTIONS LLCInactiveTIPRANAVIR CAPSULES 250 MG (IMPRINTED)

DMF 177832004

RP SCHERER GMBH AND CO KGInactiveTIPRANAVIR CAPSULES 250 MG (IMPRINT)

DMF 207072007

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Apr 4, 2024	SUPPL -30	View Letter (PDF)
Jun 19, 2020	SUPPL -21	View Letter (PDF)
Jul 6, 2018	SUPPL -18	View Letter (PDF)
Sep 20, 2016	SUPPL -16	View Letter (PDF)
Apr 1, 2015	SUPPL -15	View Letter (PDF)
Apr 8, 2014	SUPPL -14	View Letter (PDF)
Feb 27, 2012	SUPPL -13	View Letter (PDF)
Apr 7, 2011	SUPPL -11	View Letter (PDF)
Sep 7, 2010	SUPPL -9	View Letter (PDF)
May 3, 2010	SUPPL -8	View Letter (PDF)
Jun 24, 2009	SUPPL -6	View Letter (PDF)
Jun 26, 2008	SUPPL -5	View Letter (PDF)
Oct 10, 2007	SUPPL -3	View Letter (PDF)
May 29, 2007	SUPPL -4	View Letter (PDF)
Aug 18, 2006	SUPPL -2	View Letter (PDF)
Aug 18, 2006	SUPPL -1	View Letter (PDF)
Jun 24, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 22, 2005

No patent or exclusivity listings for this strength.