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TERIPARATIDE

ANDA

TERIPARATIDE | A213641 | AMPHASTAR PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FORTEO(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AMPHASTAR PHARMACEUTICALS INC. v. ELI LILLY AND COMPANY 1:2021cv01922 1 patentANDA 213641Teriparatide	INSD	2021-06-29	Terminated 2021-10-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

Products (1)

#001 — 0.56MG/2.24ML (0.25MG/ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 12, 2025

No patent or exclusivity listings for this strength.