Viewing data from:

PROCYSBI

NDA

CYSTEAMINE BITARTRATE | N203389 | HORIZON THERAPEUTICS USA INC

2 strengths12 unique patents0 unique exclusivities

Patent Timeline

12 unique patents by expiration date

Expiring < 1yr (5)Active (7)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Mar. 22, 2028

Dec. 17, 2034

Jul. 26, 2027

Jul. 26, 2027

Dec. 17, 2034

Jul. 26, 2027

Jul. 26, 2027

Jul. 26, 2027

Feb. 16, 2037

Feb. 16, 2037

Feb. 16, 2037

Feb. 16, 2037

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
HORIZON ORPHAN LLC et al v. LUPIN LIMITED et al 2:2020cv10339 11 patentsANDA 214400cysteamine bitartrate	D.N.J.	2020-08-11	Terminated 2021-10-06	—

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 Procysbi (2023)

Total Spending

$39.3M

Total Claims

531

Beneficiaries

Avg Cost/Unit

$171.57

Spending Trend

$32.9M(2019)→$37.1M(2020)→$41.2M(2021)→$43.3M(2022)→$39.3M(2023)

YoY Change:+9.3%

5yr CAGR:+14.1%

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

API Supply Chain7 active DMFs

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

CAMBREX PROFARMACO MILANO SRLCYSTEAMINE BITARTRATE

DMF 96191992

ACIC PHARMACEUTICALS INCCYSTEAMINE BITARTRATE

DMF 268162013

CAMBREX PROFARMACO MILANO SRLCYSTEAMINE BITARTRATE (RP)

DMF 275742013

LUPIN MANUFACTURING SOLUTIONS LTDCYSTEAMINE BITARTRATE

DMF 326682018

MAITHRI LABORATORIES PRIVATE LTDCYSTEAMINE BITARTRATE (MONOHYDRATE)

DMF 357582021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCYSTEAMINE BITARTRATE

DMF 370942022

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPACYSTEAMINE BITARTRATE

DMF 382092023

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 15, 2022	SUPPL -27	View Letter (PDF)
Jun 25, 2020	SUPPL -23	View Letter (PDF)
Jun 4, 2019	SUPPL -22	View Letter (PDF)
Dec 29, 2017	SUPPL -20	View Letter (PDF)
Sep 26, 2017	SUPPL -17	View Letter (PDF)
Aug 18, 2015	SUPPL -10	View Letter (PDF)
May 1, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

12 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Apr 30, 2013

Patents (12)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8026284	Sep 22, 2027PED: Mar 22, 2028	PED	—	—		—
9173851	Jun 17, 2034PED: Dec 17, 2034	PED	—	Yes	—	—
9192590	Jan 26, 2027PED: Jul 26, 2027	PED	—	—		—
9198882	Jan 26, 2027PED: Jul 26, 2027	PED	—	—		—
9233077	Jun 17, 2034PED: Dec 17, 2034	PED	—	Yes	—	—
9925156	Jan 26, 2027PED: Jul 26, 2027	PED	Yes	Yes		—
9925157	Jan 26, 2027PED: Jul 26, 2027	PED	Yes	Yes		—
9925158	Jan 26, 2027PED: Jul 26, 2027	PED	Yes	Yes		—
10143665	Aug 16, 2036PED: Feb 16, 2037	PED	—	—		—
10328037	Aug 16, 2036PED: Feb 16, 2037	PED	—	—		—
10548859	Aug 16, 2036PED: Feb 16, 2037	PED	—	—		—
10905662	Aug 16, 2036PED: Feb 16, 2037	PED	—	—		—

#002 — EQ 75MG BASE

RLD

12 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Apr 30, 2013