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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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	CASD	2010-12-22	Terminated 2011-04-27	—

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 Firmagon (2023)

Total Spending

$1.2M

Total Claims

1,842

Beneficiaries

384

Avg Cost/Unit

$540.66

Spending Trend

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

YoY Change:+0.1%

5yr CAGR:+0.7%

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

Medicare Part B Spending

CMS physician-administered drug spending for Firmagon (2023)

Total Spending

$18.2M

Total Claims

39,818

Beneficiaries

11,600

ASP Price

—

HCPCS: J9155 — Injection, degarelix, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain6 active DMFs2 inactive

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

SHENZHEN JYMED TECHNOLOGY CO LTDDEGARELIX ACETATE

DMF 335502019

AURO PEPTIDES LTDDEGARELIX

DMF 350782020

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

DMF 362162022

FRESENIUS KABI IPSUM SRLDEGARELIX ACETATE

DMF 364992023

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

DMF 409702024

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)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	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	—	—	—	U-4417	—

#002 — EQ 120MG BASE/VIAL

RLD

9 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Dec 24, 2008