Application 208073

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIIDRA	LIFITEGRAST	SOLUTION/DROPS;OPHTHALMIC	5%	Yes	Yes

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

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
N208073-001	XIIDRA	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03
N208073-001	8592450	2026-05-17	U-1880		2016-08-03
N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03
N208073-001	9447077	2029-04-15	U-1900		2016-10-06
N208073-001	8168655	2029-05-09	U-1880		2016-08-03
N208073-001	7314938	2029-06-25		Drug substance, Drug product	2016-08-03
N208073-001	9353088	2030-10-21		Drug product	2016-08-03
N208073-001	9890141	2030-10-21		Drug substance	2018-03-05
N208073-001	8927574	2030-11-12		Drug product	2016-08-03
N208073-001	9085553	2033-07-25		Drug product	2016-08-03
N208073-001	11058677	2033-12-18		Drug product	2021-07-23

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 2 of 2 · 44 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	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-07-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-07-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-07-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-07-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208073-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208073-001	AB	1	`d06236e962d9…`
2024-05-31 18:47 UTC	2024-05	N208073-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208073-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208073-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208073-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208073-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208073-001	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 650 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	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	7314938	2029-06-25		Drug substance, Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	7314938	2029-06-25		Drug substance, Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	7314938	2029-06-25		Drug substance, Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208073-001	NCE	2021-07-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208073-001	NCE	2021-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208073-001	NCE	2021-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208073-001	NCE	2021-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208073-001	NCE	2021-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208073-001	NCE	2021-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208073-001	NCE	2021-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208073-001	NCE	2021-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208073-001	NCE	2021-07-11	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xiidra	LIFITEGRAST	Novartis Pharmaceuticals Corporation	8589d376-ac10-4ddb-9c53-2e0c8d5675c4	2025-08-18	Adverse reactions	Exact identifier application applno (NDA): 208073 application number: NDA208073 ndc (product): 0078-0911
Xiidra	LIFITEGRAST	Bausch & Lomb Incorporated	1a914080-a3c0-44be-b601-0ae3160e77eb	2024-11-21	Adverse reactions	Exact identifier application applno (NDA): 208073 application number: NDA208073

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0911	Xiidra	Lifitegrast	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0911	Xiidra	Lifitegrast	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0911	Xiidra	Lifitegrast	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0911	Xiidra	Lifitegrast	Novartis Pharmaceuticals Corporation	NDA	Current
54092-606	Xiidra	Lifitegrast	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-606	Xiidra	Lifitegrast	Shire US Manufacturing Inc.	NDA	Current
54092-606	Xiidra	Lifitegrast	Shire US Manufacturing Inc.	NDA	Current
54092-606	Xiidra	Lifitegrast	Shire US Manufacturing Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78500	SUPPL	2024-05-20
78499	SUPPL	2024-05-20
63430	SUPPL	2020-06-08
63427	SUPPL	2020-06-05
50826	SUPPL	2017-12-21
50786	SUPPL	2017-12-20
19982	ORIG	2016-07-13
10642	ORIG	2016-07-12
45000	ORIG	2016-07-11