Application 203389

Type: NDA
Sponsor: HORIZON PHARMA USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCYSBI	CYSTEAMINE BITARTRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 25MG BASE	Yes	No
002	PROCYSBI	CYSTEAMINE BITARTRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 75MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203389-001	PROCYSBI	CYSTEAMINE BITARTRATE	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-04-30
N203389-002	PROCYSBI	CYSTEAMINE BITARTRATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2013-04-30

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203389-001	9192590	2027-01-26	U-1399		2015-11-25
N203389-001	9198882	2027-01-26	U-1399		2015-12-02
N203389-001	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9192590*PED	2027-07-26		Pediatric extension
N203389-001	9198882*PED	2027-07-26		Pediatric extension
N203389-001	9925156*PED	2027-07-26		Pediatric extension
N203389-001	9925157*PED	2027-07-26		Pediatric extension
N203389-001	9925158*PED	2027-07-26		Pediatric extension
N203389-001	8026284	2027-09-22	U-1399		2013-05-24
N203389-001	8026284*PED	2028-03-22		Pediatric extension
N203389-001	9173851	2034-06-17		Drug product	2015-11-04
N203389-001	9233077	2034-06-17		Drug product	2016-01-13
N203389-001	9173851*PED	2034-12-17		Pediatric extension
N203389-001	9233077*PED	2034-12-17		Pediatric extension
N203389-001	10143665	2036-08-16	U-1399		2018-12-20
N203389-001	10328037	2036-08-16	U-1399		2019-07-25
N203389-001	10548859	2036-08-16	U-1399		2020-03-04
N203389-001	10905662	2036-08-16	U-1399		2021-03-02
N203389-001	10143665*PED	2037-02-16		Pediatric extension
N203389-001	10328037*PED	2037-02-16		Pediatric extension
N203389-001	10548859*PED	2037-02-16		Pediatric extension
N203389-001	10905662*PED	2037-02-16		Pediatric extension
N203389-002	9192590	2027-01-26	U-1399		2015-11-25
N203389-002	9198882	2027-01-26	U-1399		2015-12-02
N203389-002	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9192590*PED	2027-07-26		Pediatric extension
N203389-002	9198882*PED	2027-07-26		Pediatric extension
N203389-002	9925156*PED	2027-07-26		Pediatric extension
N203389-002	9925157*PED	2027-07-26		Pediatric extension
N203389-002	9925158*PED	2027-07-26		Pediatric extension
N203389-002	8026284	2027-09-22	U-1399
N203389-002	8026284*PED	2028-03-22		Pediatric extension
N203389-002	9173851	2034-06-17		Drug product	2015-11-04
N203389-002	9233077	2034-06-17		Drug product	2016-01-13
N203389-002	9173851*PED	2034-12-17		Pediatric extension
N203389-002	9233077*PED	2034-12-17		Pediatric extension
N203389-002	10143665	2036-08-16	U-1399		2018-12-20
N203389-002	10328037	2036-08-16	U-1399		2019-07-25
N203389-002	10548859	2036-08-16	U-1399		2020-03-04
N203389-002	10905662	2036-08-16	U-1399		2021-03-02
N203389-002	10143665*PED	2037-02-16		Pediatric extension
N203389-002	10328037*PED	2037-02-16		Pediatric extension
N203389-002	10548859*PED	2037-02-16		Pediatric extension
N203389-002	10905662*PED	2037-02-16		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,892 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203389-001	9192590	2027-01-26	U-1399		2015-11-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9198882	2027-01-26	U-1399		2015-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9192590*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9198882*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925156*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925157*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9925158*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	8026284	2027-09-22	U-1399		2013-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	8026284*PED	2028-03-22		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9173851	2034-06-17		Drug product	2015-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9233077	2034-06-17		Drug product	2016-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9173851*PED	2034-12-17		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	9233077*PED	2034-12-17		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10143665	2036-08-16	U-1399		2018-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10328037	2036-08-16	U-1399		2019-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10548859	2036-08-16	U-1399		2020-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10905662	2036-08-16	U-1399		2021-03-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10143665*PED	2037-02-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10328037*PED	2037-02-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10548859*PED	2037-02-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-001	10905662*PED	2037-02-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9192590	2027-01-26	U-1399		2015-11-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9198882	2027-01-26	U-1399		2015-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9192590*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9198882*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925156*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925157*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9925158*PED	2027-07-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	8026284	2027-09-22	U-1399			`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	8026284*PED	2028-03-22		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9173851	2034-06-17		Drug product	2015-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9233077	2034-06-17		Drug product	2016-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9173851*PED	2034-12-17		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203389-002	9233077*PED	2034-12-17		Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-001	ODE-162	2024-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-001	PED	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-002	ODE-162	2024-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-002	PED	2025-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203389-001	ODE-162	2024-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-001	PED	2025-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-002	ODE-162	2024-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-002	PED	2025-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-001	ODE-162	2024-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-001	PED	2025-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-002	ODE-162	2024-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-002	PED	2025-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-001	ODE-162	2024-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-001	PED	2025-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-002	ODE-162	2024-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-002	PED	2025-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-001	ODE-162	2024-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-001	PED	2025-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-002	ODE-162	2024-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-002	PED	2025-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-001	ODE-162	2024-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-001	PED	2025-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-002	ODE-162	2024-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-002	PED	2025-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-001	ODE-162	2024-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-001	PED	2025-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-002	ODE-162	2024-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-002	PED	2025-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-001	ODE-162	2024-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-001	PED	2025-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-002	ODE-162	2024-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-002	PED	2025-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203389-001	ODE-162	2024-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-001	PED	2025-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-002	ODE-162	2024-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-002	PED	2025-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-001	ODE-162	2024-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-001	PED	2025-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-002	ODE-162	2024-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-002	PED	2025-06-22	`79d66fd596c7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCYSBI	CYSTEAMINE BITARTRATE	Horizon Therapeutics USA, Inc.	d3a3ec28-f746-463a-bb92-3bc8826db09e	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203389 application number: NDA203389 ndc (product): 75987-101 ndc (product): 75987-100

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Pharma Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Pharma Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-100	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Pharma Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Pharma Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current
75987-101	PROCYSBI	Cysteamine bitartrate	Horizon Therapeutics USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70165	SUPPL	2022-02-15
70157	SUPPL	2022-02-14
63703	SUPPL	2020-06-25
63698	SUPPL	2020-06-25
58948	SUPPL	2019-06-04
58929	SUPPL	2019-06-03
55076	SUPPL	2018-08-02
50966	SUPPL	2017-12-29
49862	SUPPL	2017-09-26
49857	SUPPL	2017-09-26
51503	SUPPL	2015-10-06
10207	SUPPL	2015-08-18
40293	SUPPL	2015-08-17
43429	ORIG	2014-03-06
24433	ORIG	2014-03-06
51502	SUPPL	2013-08-19
40292	ORIG	2013-05-01
10206	ORIG	2013-05-01
54147	SUPPL	1900-01-01
54145	SUPPL	1900-01-01
54143	SUPPL	1900-01-01
52584	ORIG	1900-01-01
52583	ORIG	1900-01-01
52582	ORIG	1900-01-01