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NUBEQA

NDA

DAROLUTAMIDE | N212099 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength10 unique patents1 unique exclusivity

Patent Timeline

10 unique patents, 1 exclusivity by expiration date

Active (10)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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Today

Mar. 25, 2033

Oct. 27, 2030

Jan. 28, 2036

Jan. 28, 2036

Oct. 27, 2030

Jan. 28, 2036

Oct. 27, 2030

Feb. 27, 2038

Jun. 17, 2042

Jul. 2, 2040

I-971

Jun. 3, 2028

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 (3 active) from PACER

Case	Court	Filed	Status	Judge
Orion Corporation et al v. MSN Laboratories Private Limited et al 1:2025cv01201 4 patentsANDA 220822darolutamide	D. Del.	2025-09-26	Active	—
Orion Corporation et al v. Alembic Pharmaceuticals Limited 1:2025cv00825 4 patentsANDA 220499darolutamide	D. Del.	2025-07-03	Active	—
Bayer Consumer Care AG et al v. Hetero USA Inc. et al 1:2023cv01221 4 patentsANDA 218787darolutamide	D. Del.	2023-10-26	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov — 6 recruiting, 2 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies NCT05794906	Phase 3	Active	Bayer	985	2023-04-03 → 2030-03-29
A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described NCT04122976	—	Active	Bayer	805	2020-01-30 → 2026-10-07
177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial NCT07677566	Phase 4	Not Yet Recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	20	2026-07-01 → 2028-12-31
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment NCT07538843	—	Not Yet Recruiting	Bayer	800	2026-07-30 → 2030-01-30
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea NCT06334120	—	Recruiting	Bayer	600	2024-09-25 → 2028-06-30
SNV1521 in Participants With Advanced Solid Tumors NCT06220864	Phase 1	Recruiting	Synnovation Therapeutics, Inc.	400	2024-02-23 → 2027-12
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer NCT07140900	Phase 1	Recruiting	Amgen	60	2025-10-07 → 2030-03-30
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)NCT07190300	Phase 1/2	Recruiting	Novartis Pharmaceuticals	181	2026-01-13 → 2032-08-02
Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer NCT05171387	Phase 2	Completed	Bayer	78	2021-11-30 → 2025-02-24
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.NCT05938270	Phase 1	Completed	AstraZeneca	113	2023-09-21 → 2026-06-15

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

Medicare Part D Spending

CMS annual spending data for Nubeqa (2023)

Total Spending

$576.4M

Total Claims

43,925

Beneficiaries

7,174

Avg Cost/Unit

$113.38

Spending Trend

$8.0M(2019)→$99.9M(2020)→$223.5M(2021)→$322.3M(2022)→$576.4M(2023)

YoY Change:+5.7%

5yr CAGR:+3.7%

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

API Supply Chain6 active DMFs

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

MSN LABORATORIES PRIVATE LTDDAROLUTAMIDE

DMF 366972022

MSN LABORATORIES PRIVATE LTDDAROLUTAMIDE

DMF 375852022

ALEMBIC PHARMACEUTICALS LTDDAROLUTAMIDE

DMF 379122023

HETERO LABS LTDDAROLUTAMIDE PREMIX

DMF 382742023

CHANGZHOU PHARMACEUTICAL FACTORYDAROLUTAMIDE

DMF 421272025

SICHUAN ELIXIR PHARMACEUTICAL CO LTDDAROLUTAMIDE

DMF 432002025

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2025	SUPPL -8	View Letter (PDF)
Oct 16, 2023	SUPPL -4	View Letter (PDF)
Aug 8, 2022	SUPPL -2	View Letter (PDF)
Jan 8, 2021	SUPPL -1	View Letter (PDF)
Jul 31, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

RLD

10 patents1 exclusivity▴

TABLET;ORAL | Approved: Jul 30, 2019

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8975254	Mar 25, 2033	—	Yes	Yes		—
9657003	Oct 27, 2030	—	Yes	Yes		—
10010530	Jan 28, 2036	—	Yes	—	—	—
10383853	Jan 28, 2036	—	Yes	—	—	—
10711013	Oct 27, 2030	—	Yes	Yes	—	—
10835515	Jan 28, 2036	—	—	Yes		—
11046713	Oct 27, 2030	—	Yes	—	—	—
11168058	Feb 27, 2038	—	Yes	Yes	—	—
12329742	Jun 17, 2042	—	—	Yes	—	—
12611397	Jul 2, 2040	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
I-971	Jun 3, 2028	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Bayer Healthcare's patent 12611397 for Nubeqa (darolutamide) was added to the Orange Book for NDA 212099.

New: New record