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TERIPARATIDE

ANDA

TERIPARATIDE | A208569 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FORTEO(TE code: AP)

Medicare Part D Spending

CMS annual spending data for Teriparatide (2023)

Total Spending

$89.1M

Total Claims

30,242

Beneficiaries

7,021

Avg Cost/Unit

$1068.13

Spending Trend

$957K(2020)→$24.6M(2021)→$62.4M(2022)→$89.1M(2023)

YoY Change:+3.6%

5yr CAGR:+1.6%

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

API Supply Chain12 active DMFs

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

AMBIO INCTERIPARATIDE USP (ACETATE)

DMF 284642017

RICHTER-HELM BIOTEC GMBH AND CO KGTERIPARATIDE

DMF 291222015

CHENGDU SHENGNUO BIOPHARM CO LTDTERIPARATIDE

DMF 321442019

AURO PEPTIDES LTDTERIPARATIDE

DMF 330792018

SCINOPHARM TAIWAN LTDTERIPARATIDE USP

DMF 332102019

AMPHASTAR NANJING PHARMACEUTICALS INCTERIPARATIDE USP

DMF 338572019

MSN LIFE SCIENCES PRIVATE LTDTERIPARATIDE USP

DMF 347132020

SUN PHARMACEUTICAL INDUSTRIES LTDTERIPARATIDE USP

DMF 355832021

ALEMBIC PHARMACEUTICALS LTDTERIPARATIDE

DMF 389232023

HARBIN JIXIANGLONG BIOTECH CO LTDTERIPARATIDE

DMF 400362024

SHENZHEN JYMED TECHNOLOGY CO LTDTERIPARATIDE

DMF 411692025

HEFEI XINZHU BIOLOGICAL TECHNOLOGY CO LTDTERIPARATIDE

DMF 422242025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 14, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.56MG/2.24ML (0.25MG/ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Nov 16, 2023

No patent or exclusivity listings for this strength.