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TYMLOS

NDA

ABALOPARATIDE | N208743 | RADIUS HEALTH INC

1 strength9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Expiring < 1yr (1)Active (8)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Apr. 28, 2031

Apr. 28, 2031

Nov. 8, 2027

Oct. 3, 2027

Apr. 30, 2038

Jan. 10, 2040

Jan. 10, 2040

Apr. 30, 2038

Apr. 30, 2038

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Radius Health, Inc. v. Orbicular Pharmaceutical Technologies Private Limited et al 1:2024cv11770 1 patentabaloparatide	D. Mass.	2024-07-10	Terminated 2025-12-23	—
Radius Health, Inc. et al v. Orbicular Pharmaceutical Technologies Private Limited 1:2022cv11546	D. Mass.	2022-09-20	Terminated 2025-08-13	—
Eli Lilly and Company v. Radius Health, Inc. 1:2021cv01003 1 patentteriparatide [rDNA origin] injection; abaloparatide	D. Del.	2021-07-08	Terminated 2021-08-10	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery NCT03841058	Phase 2	Active	Hospital for Special Surgery, New York	96	2019-08-14 → 2027-02
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone NCT04467983	Phase 4	Active	Hospital for Special Surgery, New York	70	2021-02-01 → 2026-12-31
The Effect of Osteoporotic Medications on Vertebral Bone Quality Score NCT07587775	Phase 2	By Invitation	State University of New York at Buffalo	60	2026-06-18 → 2028-12-31
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption NCT03710889	Phase 3	Completed	Radius Health, Inc.	23	2018-09-20 → 2020-07-15
A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes NCT03746041	Phase 1	Completed	University of Rochester	20	2019-02-14 → 2022-06-06
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)NCT04366726	Phase 1	Completed	Radius Health, Inc.	22	2019-04-09 → 2019-05-14
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)NCT03512262	Phase 3	Completed	Radius Health, Inc.	228	2018-05-03 → 2021-09-08
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis NCT01674621	Phase 2	Completed	Radius Health, Inc.	250	2012-09-25 → 2013-08-02
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis NCT04064411	Phase 3	Completed	Radius Health, Inc.	511	2019-08-05 → 2021-11-09
Abaloparatide and Pelvic Fracture Healing NCT04249232	Phase 2	Completed	Hospital for Special Surgery, New York	48	2020-09-17 → 2024-04-25

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$1711.85

Highest Price

$1711.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70539-0001-02TYMLOS 80MCG/0.04ML INJ,PEN,1.56ML	$1711.85	FSS	Radius Health, Inc.	02/28/2031

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

Medicare Part D Spending

CMS annual spending data for Tymlos (2024)

Total Spending

$257.6M

Total Claims

88,564

Beneficiaries

16,530

Avg Cost/Unit

$1690.96

Spending Trend

$109.8M(2019)→$132.8M(2020)→$137.8M(2021)→$156.7M(2022)→$197.6M(2023)→$257.6M(2024)

YoY Change:+0.1%

5yr CAGR:+7.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

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

MSN LIFE SCIENCES PRIVATE LTDABALOPARATIDE

DMF 346972020

MATRIX PHARMACORP PRIVATE LTDABALOPARATIDE

DMF 364752021

HYBIO PHARMACEUTICAL CO LTDABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE

DMF 392232023

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Aug 6, 2026	SUPPL -18	View Letter (PDF)
Apr 9, 2025	SUPPL -17	View Letter (PDF)
Dec 27, 2023	SUPPL -15	View Letter (PDF)
Sep 21, 2021	SUPPL -9	View Letter (PDF)
Oct 27, 2020	SUPPL -7	View Letter (PDF)
Oct 23, 2018	SUPPL -3	View Letter (PDF)
Jun 27, 2018	SUPPL -4	View Letter (PDF)
Feb 9, 2018	SUPPL -1	View Letter (PDF)
Apr 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.12MG/1.56ML (2MG/ML)

RLD

12 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Apr 28, 2017

Patents (12)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE49444	Apr 28, 2031	—	—	—		—
RE49444	Apr 28, 2031	—	—	—		—
7803770	Apr 28, 2031	—	—	—		—
8148333	Nov 8, 2027	—	—	Yes	—	—
8748382	Oct 3, 2027	—	—	—		—
8748382	Oct 3, 2027	—	—	—		—
10996208	Apr 30, 2038	—	—	Yes	—	—
11255842	Jan 10, 2040	—	—	—		—
11680942	Jan 10, 2040	—	—	—		—
11782041	Apr 30, 2038	—	—	Yes		—
11782041	Apr 30, 2038	—	—	Yes		—
11977067	Apr 30, 2038	—	—	Yes	—	—