Viewing data from:

CERDELGA

NDA

ELIGLUSTAT TARTRATE | N205494 | GENZYME CORP

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expired (1)Active (4)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

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2039

Today

Jun. 26, 2026

Dec. 13, 2038

Jan. 31, 2031

Nov. 24, 2030

Jun. 5, 2032

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
GENZYME CORP. et al v. ZENARA PHARMA PRIVATE LIMITED 3:2019cv05160 4 patentsANDA 212420eliglustat	D.N.J.	2019-02-08	Terminated 2019-02-28	—
GENZYME CORP. et al v. DR. REDDYS LABORATORIES, INC. et al 3:2018cv16378 1 patentANDA 212449Eliglustat	D.N.J.	2018-11-21	Terminated 2019-02-13	—
Genzyme Corp. et al v. Apotex Corp. et al 1:2018cv01795 1 patentANDA 212425eliglustat	D. Del.	2018-11-14	Terminated 2021-03-11	—
Genzyme Corp. et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv01796 4 patentsANDA 212474Eliglustat	D. Del.	2018-11-14	Terminated 2020-08-03	—

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 Cerdelga (2023)

Total Spending

$37.6M

Total Claims

1,242

Beneficiaries

119

Avg Cost/Unit

$575.87

Spending Trend

$24.4M(2019)→$27.5M(2020)→$31.9M(2021)→$36.7M(2022)→$37.6M(2023)

YoY Change:+3.8%

5yr CAGR:+4.7%

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

API Supply Chain7 active DMFs

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

DR REDDYS LABORATORIES LTDELIGLUSTAT TARTRATE

DMF 314752017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE

DMF 325722018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE (PREMIX)

DMF 326122018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE

DMF 326532018

APOTEX INCELIGLUSTAT TARTRATE (1:0.5)

DMF 327242018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE PREMIX

DMF 328602018

HETERO DRUGS LTDELIGLUSTAT TARTRATE

DMF 416192025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 13, 2018	SUPPL -3	View Letter (PDF)
Aug 20, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 84MG BASE

RLDAB

5 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 19, 2014

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7196205	Jun 26, 2026	—	Yes	—	—	—
10888544	Dec 13, 2038	—	—	—		—
10888547	Jan 31, 2031	—	—	—		—
11458119	Nov 24, 2030	—	Yes	Yes	—	—
12465586	Jun 5, 2032	—	—	—		—