Viewing data from:

ETRAVIRINE

ANDA

ETRAVIRINE | A214196 | AMNEAL EU LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: INTELENCE

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$11.41

per ea

Lowest NADAC/Unit

$7.77

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60219172206ETRAVIRINE 200 MG TABLET	$11.41	EA	Generic	—	2026-06-17
60219172107ETRAVIRINE 100 MG TABLET	$7.77	EA	Generic	—	2026-03-18

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$859.31

Highest Price

$859.31

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0473-12ETRAVIRINE 100MG TAB	$859.31	FSS	AvKare, LLC	06/14/2028
42291-0474-60ETRAVIRINE 200MG TAB	$859.31	FSS	AvKare, LLC	06/14/2028

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 14, 2021

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 2021

#003 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 2021