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LEVORPHANOL TARTRATE

ANDA

LEVORPHANOL TARTRATE | A074278 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Levorphanol Tartrate (2023)

Total Spending

$17.8M

Total Claims

4,547

Beneficiaries

657

Avg Cost/Unit

$35.31

Spending Trend

$40.1M(2019)→$32.2M(2020)→$27.5M(2021)→$17.3M(2022)→$17.8M(2023)

YoY Change:-4.8%

5yr CAGR:-1.9%

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

API Supply Chain4 active DMFs3 inactive

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

SPECGX LLCLEVORPHANOL TARTRATE USP SPECIAL

DMF 188232005

NOVITIUM PHARMA LLCLEVORPHANOL TARTRATE USP

DMF 332242018

AMPAC FINE CHEMICALS LLCLEVORPHANOL TARTRATE DRUG SUBSTANCE

DMF 343042020

NORAMCO LLCLEVORPHANOL TARTRATE

DMF 359772021

HOFFMANN LA ROCHE INCInactiveLEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL.

DMF 37261980

MALLINCKRODT PHARMS DIV MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 76251988

MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 99681992

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 16, 2018	SUPPL -11	View Letter (PDF)
Mar 31, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 31, 2000

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 18, 2018

#003 — 3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 18, 2018