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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

Active (9)Today

2026

2027

2028

2029

2030

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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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tymlos (2023)

Total Spending

$197.6M

Total Claims

69,151

Beneficiaries

12,979

Avg Cost/Unit

$1690.13

Spending Trend

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

YoY Change:+10.6%

5yr CAGR:+9.2%

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LIFE SCIENCES PRIVATE LTDABALOPARATIDE

DMF 346972020

MATRIX PHARMACORP PRIVATE LTDABALOPARATIDE

DMF 364752021

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
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

9 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Apr 28, 2017

Patents (9)

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