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PROCYSBI

Cysteamine bitartrate · Granule, Delayed Release

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PROCYSBI
Generic name
Cysteamine bitartrate
Dosage form
Granule, Delayed Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Horizon Therapeutics USA, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cysteamine Bitartrate 300 mg/1 1421467 View
Cysteamine Bitartrate 75 mg/1 1421467 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Granule, Delayed Release
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cystine Depleting Agent [EPC] EPC 4 members — no class page
Cystine Disulfide Reduction [MoA] MoA 8 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213491
Application type
NDA · New Drug Application
Approval date
February 14, 2020
Sponsor
HORIZON
Products on application
2
Submissions recorded
2
Products approved under application 213491.
Product Trade name Form Strength Ingredient Status TE Flags
213491-001 PROCYSBI GRANULE, DELAYED RELEASE CYSTEAMINE BITARTRATE Prescription — RLD
213491-002 PROCYSBI GRANULE, DELAYED RELEASE CYSTEAMINE BITARTRATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9198882 January 26, 2027 001 No U-1399 March 13, 2020
9192590 January 26, 2027 001 No U-1399 March 13, 2020
9925156 January 26, 2027 001 No U-1399 March 13, 2020
9925157 January 26, 2027 001 No U-1399 March 13, 2020
9925158 January 26, 2027 001 No U-1399 March 13, 2020
9192590 January 26, 2027 002 No U-1399 March 13, 2020
9198882 January 26, 2027 002 No U-1399 March 13, 2020
9925157 January 26, 2027 002 No U-1399 March 13, 2020
9925158 January 26, 2027 002 No U-1399 March 13, 2020
9925156 January 26, 2027 002 No U-1399 March 13, 2020
9198882*PED July 26, 2027 001 No —
9192590*PED July 26, 2027 001 No —
9925156*PED July 26, 2027 001 No —
9925157*PED July 26, 2027 001 No —
9925158*PED July 26, 2027 001 No —
9192590*PED July 26, 2027 002 No —
9198882*PED July 26, 2027 002 No —
9925157*PED July 26, 2027 002 No —
9925158*PED July 26, 2027 002 No —
9925156*PED July 26, 2027 002 No —
8026284 September 22, 2027 001 No U-1399 March 13, 2020
8026284 September 22, 2027 002 No U-1399 March 13, 2020
8026284*PED March 22, 2028 001 No —
8026284*PED March 22, 2028 002 No —
9173851 June 17, 2034 001 No March 13, 2020
9233077 June 17, 2034 001 No March 13, 2020
9233077 June 17, 2034 002 No March 13, 2020
9173851 June 17, 2034 002 No March 13, 2020
9173851*PED December 17, 2034 001 No —
9233077*PED December 17, 2034 001 No —
9173851*PED December 17, 2034 002 No —
9233077*PED December 17, 2034 002 No —
10143665 August 16, 2036 001 No U-1399 March 13, 2020
10328037 August 16, 2036 001 No U-1399 March 13, 2020
10548859 August 16, 2036 001 No U-1399 March 13, 2020
10905662 August 16, 2036 001 No U-1399 March 2, 2021
10548859 August 16, 2036 002 No U-1399 March 13, 2020
10143665 August 16, 2036 002 No U-1399 March 13, 2020
10328037 August 16, 2036 002 No U-1399 March 13, 2020
10905662 August 16, 2036 002 No U-1399 March 2, 2021
10905662*PED February 16, 2037 001 No —
10143665*PED February 16, 2037 001 No —
10328037*PED February 16, 2037 001 No —
10548859*PED February 16, 2037 001 No —
10905662*PED February 16, 2037 002 No —
10548859*PED February 16, 2037 002 No —
10143665*PED February 16, 2037 002 No —
10328037*PED February 16, 2037 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213491.
Type No. Action Status Date Review
Supplement 2 Labeling Approved February 11, 2022 901 Required
Original application 1 Type 3 - New Dosage Form Approved February 14, 2020 Standard

Review documents

  • 0 · Supplement · February 15, 2022
  • 0 · Supplement · February 14, 2022
  • 0 · Original application · May 29, 2020
  • 0 · Original application · February 19, 2020
  • 0 · Original application · February 18, 2020

Adverse event reports

Source: openFDA FAERS
1,034
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CYSTEAMINE BITARTRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
75987-140-13 75987-140 Horizon Therapeutics USA, Inc. 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET February 14, 2020
75987-140-14 75987-140 Horizon Therapeutics USA, Inc. 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET February 14, 2020
75987-145-13 75987-145 Horizon Therapeutics USA, Inc. 60 PACKET in 1 CARTON (75987-145-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET February 14, 2020
75987-145-14 75987-145 Horizon Therapeutics USA, Inc. 120 PACKET in 1 CARTON (75987-145-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET February 14, 2020
75987-140 75987-140 Horizon Therapeutics USA, Inc. — February 14, 2020
75987-145 75987-145 Horizon Therapeutics USA, Inc. — February 14, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.