Is EyePoint US, Inc. FDA approved?

EyePoint US, Inc. holds 2 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are EyePoint US, Inc.'s drugs manufactured?

The FDA register lists Northbridge, MA; Watertown, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

EyePoint US, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 0
Live patents: 5
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling2Finished drug manufacture2Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
EyePoint US, Inc.	600 Commerce Dr, Northbridge, Massachusetts (MA) 01534, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3036800967145005529
EyePoint US, Inc.	480 Pleasant Street B300, Watertown, Massachusetts (MA) 02472, United States (USA)	Labelling, Finished drug manufacture	3005508657968003785

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10799642	DEXYCU KITdexamethasone	product	May 2032
10028965	DEXYCU KITdexamethasone	use	May 2034
10159683	DEXYCU KITdexamethasone	product	May 2034
10022502	DEXYCU KITdexamethasone	use	Jun 2034
11097061	DEXYCU KITdexamethasone	product	Jun 2039

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Enquiry

Common questions

Is EyePoint US, Inc. FDA approved?: EyePoint US, Inc. holds 2 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are EyePoint US, Inc.'s drugs manufactured?: The FDA register lists Northbridge, MA; Watertown, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.