Viewing data from:

INTELENCE

NDA

ETRAVIRINE | N022187 | JANSSEN RESEARCH AND DEVELOPMENT LLC

3 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

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

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 Intelence (2023)

Total Spending

$4.7M

Total Claims

3,100

Beneficiaries

590

Avg Cost/Unit

$23.29

Spending Trend

$80.1M(2019)→$68.2M(2020)→$46.9M(2021)→$12.9M(2022)→$4.7M(2023)

YoY Change:-1.6%

5yr CAGR:+1.4%

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

API Supply Chain5 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

JANSSEN PHARMACEUTICA NVETRAVIRINE (R165335) DRUG SUBSTANCE

DMF 204402007

HETERO LABS LTDETRAVIRINE

DMF 255502011

MATRIX PHARMACORP PRIVATE LTDETRAVIRINE

DMF 288132014

MSN LIFE SCIENCES PRIVATE LTDETRAVIRINE [ROUTE CODE "EV"]

DMF 294042015

HETERO LABS LTDETRAVIRINE PREMIX

DMF 358352021

APOTEX PHARMACHEM INDIA PVT LTDInactiveETRAVIRINE

DMF 279232014

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2019	SUPPL -25	View Letter (PDF)
Nov 15, 2018	SUPPL -23	View Letter (PDF)
Jul 23, 2018	SUPPL -24	View Letter (PDF)
Aug 21, 2014	SUPPL -16	View Letter (PDF)
Mar 1, 2013	SUPPL -12	View Letter (PDF)
Mar 1, 2013	SUPPL -11	View Letter (PDF)
Mar 1, 2013	SUPPL -14	View Letter (PDF)
Aug 15, 2012	SUPPL -10	View Letter (PDF)
Mar 28, 2012	SUPPL -9	View Letter (PDF)
Oct 12, 2011	SUPPL -8	View Letter (PDF)
Dec 28, 2010	SUPPL -7	View Letter (PDF)
Dec 22, 2010	SUPPL -6	View Letter (PDF)
Mar 3, 2010	SUPPL -3	View Letter (PDF)
Nov 10, 2009	SUPPL -2	View Letter (PDF)
Jan 23, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 18, 2008

No patent or exclusivity listings for this strength.

#002 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 22, 2010

#003 — 25MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2012