Application 213972

Type: NDA
Sponsor: ITERUM THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORLYNVAH	PROBENECID; SULOPENEM ETZADROXIL	TABLET;ORAL	500MG;500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213972-001	ORLYNVAH	PROBENECID; SULOPENEM ETZADROXIL	500MG;500MG	TABLET / ORAL		RLD, RS	2024-10-25

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12
N213972-001	11554112	2039-04-01	U-4026		2024-11-12
N213972-001	12109197	2039-04-01	U-4026		2024-11-12
N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12
N213972-001	12544337	2039-12-23	U-4026	Drug product	2026-02-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213972-001	NCE	2029-10-25
N213972-001	GAIN	2034-10-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD	2024-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	ORLYNVAH	500MG;500MG	TABLET / ORAL	RLD, RS	2024-10-25	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	7795243	2029-06-03	U-4026	Drug substance, Drug product	2024-11-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	11554112	2039-04-01	U-4026		2024-11-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	12109197	2039-04-01	U-4026		2024-11-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	11478428	2039-12-23	U-4026	Drug product	2024-11-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	12544337	2039-12-23	U-4026	Drug product	2026-02-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213972-001	NCE	2029-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213972-001	GAIN	2034-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	NCE	2029-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213972-001	GAIN	2034-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213972-001	NCE	2029-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213972-001	GAIN	2034-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	NCE	2029-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213972-001	GAIN	2034-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	NCE	2029-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213972-001	GAIN	2034-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	NCE	2029-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213972-001	GAIN	2034-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	NCE	2029-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213972-001	GAIN	2034-10-25	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	NCE	2029-10-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213972-001	GAIN	2034-10-25	`a50c72e98297…`

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
ORLYNVAH	SULOPENEM ETZADROXIL AND PROBENECID	ITERUM THERAPEUTICS US LIMITED	24c451c0-4cfb-37f3-e063-6394a90a895e	2025-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213972 application number: NDA213972

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84664	SUPPL	2026-01-06
84598	SUPPL	2025-12-31
81729	SUPPL	2025-03-25
81726	SUPPL	2025-03-25
80535	ORIG	2024-12-06
80012	ORIG	2024-10-28
79981	ORIG	2024-10-25