Viewing data from:

FIRMAGON

NDA

DEGARELIX ACETATE | N022201 | FERRING PHARMACEUTICALS INC

2 strengths9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Active (9)Today

2027

2028

2029

2030

2031

2032

Today

Apr. 27, 2032

Feb. 10, 2029

Apr. 27, 2032

Feb. 10, 2029

Feb. 10, 2029

Apr. 27, 2032

Apr. 27, 2032

Feb. 20, 2029

Feb. 20, 2029

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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Ferring Pharmaceuticals Inc. et al v. Jiangsu Hansoh Pharmaceutical Group Co., Ltd. 1:2022cv01474	D. Del.	2022-11-09	Terminated 2024-11-12	—
Ferring Pharmaceuticals Inc. et al v. Eugia Pharma Specialties Ltd. et al 1:2022cv00017 8 patentsANDA 215800degarelix	D. Del.	2022-01-04	Terminated 2024-06-07	—
Ferring Pharmaceuticals Inc. et al v. Fresenius Kabi USA, LLC et al 1:2020cv00431 5 patentsANDA 211999degarelix	D. Del.	2020-03-26	Terminated 2023-01-30	—
Salk Institute for Biological Studies v. Ferring Pharmaceuticals, Inc et al 3:2010cv02649 7 patentsdegarelix	S.D. Cal.	2010-12-22	Terminated 2011-04-27	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Ferring Pharmaceuticals, Inc. (Ferring)-CONFIDENTAIL FDA-2022-P-0160 · 16 docket documents Ferring Pharmaceuticals, Inc. submitted a citizen petition on February 9, 2022, requesting that the FDA require in vivo bioequivalence studies for any abbreviated new drug application (ANDA) under section 505(j) or new drug application (NDA) under section 505(b)(2) that references Firmagon (degareli	505(q)	2022-02-17	Denied	Ferring Pharmaceuticals, Inc. (Ferring)-CONFIDENTAIL

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

61 trials from ClinicalTrials.gov — 2 recruiting, 8 active, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer NCT01990196	Phase 2	Active	Jonsson Comprehensive Cancer Center	45	2014-09-23 → 2026-09-30
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer NCT02799706	Phase 3	Active	European Organisation for Research and Treatment of Cancer - EORTC	885	2017-09-25 → 2026-06-30
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer NCT03361735	Phase 2	Active	City of Hope Medical Center	25	2018-08-29 → 2027-01-06
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation NCT01746849	Phase 2	Active	Memorial Sloan Kettering Cancer Center	82	2012-12 → 2026-12
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors NCT04126070	Phase 2	Active	Xiao X. Wei, MD	47	2020-05-11 → 2026-06-30
Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy NCT03080116	Phase 2	Active	Universitaire Ziekenhuizen KU Leuven	90	2019-03-28 → 2024-07-01
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer NCT01786265	Phase 2	Active	M.D. Anderson Cancer Center	310	2013-02-05 → 2027-02-01
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer NCT03951831	Phase 2	Active	Mark Stein	26	2019-05-16 → 2028-04
Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer NCT04176081	Phase 2	Not Yet Recruiting	University Health Network, Toronto	208	2024-07-02 → 2028-12
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer NCT03678025	Phase 3	Recruiting	SWOG Cancer Research Network	1,273	2018-09-24 → 2031-10-01

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

VA Federal Supply Schedule

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

Lowest Price

$241.21

Highest Price

$771.86

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55566-8303-01FIRMAGON KIT 80MG/VIL,INJ	$241.21	FSS	Ferring Pharmaceuticals, Inc.	12/31/2026
55566-8303-01FIRMAGON KIT 80MG/VIL,INJ	$241.21	Big4	Ferring Pharmaceuticals, Inc.	12/31/2026
55566-8403-01FIRMAGON KIT 240MG/VIL,INJ	$771.86	FSS	Ferring Pharmaceuticals, Inc.	12/31/2026
55566-8403-01FIRMAGON KIT 240MG/VIL,INJ	$771.86	Big4	Ferring Pharmaceuticals, Inc.	12/31/2026

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

Medicare Part D Spending

CMS annual spending data for Firmagon (2024)

Total Spending

$1.2M

Total Claims

2,082

Beneficiaries

436

Avg Cost/Unit

$501.43

Spending Trend

$1.0M(2019)→$1.1M(2020)→$1.2M(2021)→$1.1M(2022)→$1.2M(2023)→$1.2M(2024)

YoY Change:-7.3%

5yr CAGR:-1.2%

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

Medicare Part B Spending

CMS physician-administered drug spending for Firmagon (2024)

Total Spending

$17.0M

Total Claims

36,140

Beneficiaries

10,573

ASP Price

$4.25

Spending Trend

$18.6M(2019)→$17.8M(2020)→$18.2M(2021)→$18.6M(2022)→$18.2M(2023)→$17.0M(2024)

YoY Change:+2.8%

5yr CAGR:+2.6%

HCPCS: J9155 — Injection, degarelix, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain9 active DMFs2 inactive

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

SHENZHEN JYMED TECHNOLOGY CO LTDDEGARELIX ACETATE

DMF 335502019

AURO PEPTIDES LTDDEGARELIX

DMF 350782020

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDDEGARELIX ACETATE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 352572020

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDDEGARELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE

DMF 362162022

FRESENIUS KABI IPSUM SRLDEGARELIX ACETATE

DMF 364992023

HYBIO PHARMACEUTICAL CO LTDDEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE

DMF 389042023

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)DEGARELIX ACETATE

DMF 409702024

HYBIO PHARMACEUTICAL CO LTDDEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE

DMF 416972025

SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTDDEGARELIX ACETATE

DMF 432152025

APICORE LLCInactiveDEGARELIX ACETATE MANNITOL PREMIX 29% (STERILE)

DMF 370052023

APICORE LLCInactiveDEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE)

DMF 371132023

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2020	SUPPL -16	View Letter (PDF)
Oct 28, 2015	SUPPL -11	View Letter (PDF)
Feb 27, 2015	SUPPL -9	View Letter (PDF)
Aug 20, 2013	SUPPL -3	View Letter (PDF)
Mar 6, 2013	SUPPL -2	View Letter (PDF)
Dec 30, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 80MG BASE/VIAL

RLD

9 patents0 exclusivities▴

POWDER;SUBCUTANEOUS | Approved: Dec 24, 2008

Patents (9) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9415085	Apr 27, 2032	—	—	—	—
9579359	Feb 10, 2029	—	—	—	—
10695398	Apr 27, 2032	—	—	—	—
10729739	Feb 10, 2029	—	—	—	—
10973870	Feb 10, 2029	—	—	—	—
11766468	Apr 27, 2032	—	—	—	—
11826397	Apr 27, 2032	—	—	—	—
12514898	Feb 20, 2029	—	—	—	—
12533387	Feb 20, 2029	—	—	—	—

#002 — EQ 120MG BASE/VIAL

RLD

9 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Dec 24, 2008