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BONSITY

NDA

TERIPARATIDE | N211939 | ALVOGEN INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

116 trials from ClinicalTrials.gov, 2 active, 89 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Novel Combination Therapy for Osteoporosis in Men NCT03994172	Phase 4	Active	VA Office of Research and Development	40	2019-07-01 → 2026-06-30
Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery NCT03770338	N/A	Active	The University of Hong Kong	192	2019-03-01 → 2026-06-30
Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis NCT02239523	N/A	Completed	Shaare Zedek Medical Center	200	2017-02-21 → 2019-02-28
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis NCT00259298	Phase 4	Completed	Eli Lilly and Company	12	2005-11 → 2009-07
Once Weekly Parathyroid Hormone for Osteoporosis NCT00065637	Phase 3	Completed	University of California, San Francisco	50	2003-12 → 2005-09
PTH and Vibration in OSteoporosis Study NCT02563353	N/A	Completed	Odense University Hospital	35	2015-11 → 2019-11
Fracture (FX) Improvement With Teriparatide: FiX-IT Study NCT01705587	Phase 4	Completed	Susan L. Greenspan	13	2012-12 → 2016-09
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis NCT00503399	Phase 3	Completed	Eli Lilly and Company	92	2007-07 → 2010-10
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture NCT00887354	Phase 4	Completed	Eli Lilly and Company	224	2009-04 → 2015-08
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration NCT04026256	Phase 4	Completed	Massachusetts General Hospital	37	2019-09-02 → 2022-04-18

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$536.55

per ml

Lowest NADAC/Unit

$536.55

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47781065289TERIPARATIDE 560 MCG/2.24 ML PEN	$536.55	ML	Generic	—	2026-06-17
47781085289BONSITY 560 MCG/2.24 ML PEN	$536.55	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1619.33

Highest Price

$2559.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
47781-0652-89TERIPARATIDE 250MCG/ML (560MCG) INJ,PEN,2.24M	$1619.33	FSS	Alvogen Inc	08/31/2026
47781-0652-89TERIPARATIDE 250MCG/ML (560MCG) INJ,PEN,2.24M	$1619.33	Big4	Alvogen Inc	08/31/2026
47781-0852-89BONSITY 250MCG/ML (560MCG) INJ,PEN,2.24M	$2559.58	FSS	Alvogen Inc	08/31/2026
47781-0852-89BONSITY 250MCG/ML (560MCG) INJ,PEN,2.24M	$1925.45	Big4	Alvogen Inc	08/31/2026

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

API Supply Chain14 active DMFs

13 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

HYBIO PHARMACEUTICAL CO LTDTERIPARATIDE, NON-STERILE BULK DRUG SUBSTANCE

DMF 343882019

MSN LIFE SCIENCES PRIVATE LTDTERIPARATIDE USP

DMF 347132020

SUN PHARMACEUTICAL INDUSTRIES LTDTERIPARATIDE USP

DMF 355832021

HYBIO PHARMACEUTICAL CO LTDTERIPARATIDE, NON STERILE BULK DRUG SUBSTANCE

DMF 365022021

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

3 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -17	View Letter (PDF)
Nov 17, 2023	SUPPL -4	View Letter (PDF)
Oct 7, 2019	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: Oct 4, 2019

No patent or exclusivity listings for this strength.