Viewing data from:

MITIGO

ANDA

MORPHINE SULFATE | A204393 | PIRAMAL CRITICAL CARE INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DURAMORPH PF(TE code: AP)

Medicare Part D Spending

CMS annual spending data for Mitigo (2023)

Total Spending

$3K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$9.67

Spending Trend

$4K(2019)→$4K(2020)→$10K(2022)→$3K(2023)

YoY Change:-6.8%

5yr CAGR:-0.5%

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

API Supply Chain3 active DMFs5 inactive

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

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 16, 2018

No patent or exclusivity listings for this strength.

#002 — 25MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 16, 2018