Details for New Drug Application (NDA): 208742

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NDA 208742 describes DEXTENZA, which is a drug marketed by Ocular Therapeutix and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DEXTENZA profile page.

The generic ingredient in DEXTENZA is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for 208742

Tradename:	DEXTENZA
Applicant:	Ocular Therapeutix
Ingredient:	dexamethasone
Patents:	4

Pharmacology for NDA: 208742

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 208742

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 208742

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742	NDA	Ocular Therapeutix, Inc.	70382-204	70382-204-01	1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88)
DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742	NDA	Ocular Therapeutix, Inc.	70382-204	70382-204-10	10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT;OPHTHALMIC			Strength	0.4MG
Approval Date:	Nov 30, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 7, 2024
Regulatory Exclusivity Use:	TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Patent:	11,458,041	Patent Expiration:	Nov 16, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY
Patent:	11,458,041	Patent Expiration:	Nov 16, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

Expired US Patents for NDA 208742

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018	9,254,267	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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