Is there a generic for Aspirin; omeprazole?

The FDA Orange Book does not currently list an approved generic (ANDA) for Aspirin; omeprazole. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Aspirin; omeprazole?

YOSPRALA (NDA 205103, GENUS LIFESCIENCES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Aspirin; omeprazole?

The Orange Book lists 2 patents against Aspirin; omeprazole products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Aspirin; omeprazole are approved?

Aspirin; omeprazole is approved in the following dosage form: tablet, delayed release.

FDA Orange Book · active-ingredient family

Aspirin; omeprazole

Aspirin; omeprazole: 1 brand, 0 generics; first approved Sep 14, 2016; on patent until Jan 02, 2033.

On patentHas discontinued products

Generic status & protection

Protected until Jan 02, 2033 (earliest listed patent expiry).

Earliest patent expiry Jan 02, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 02, 2033

in 6 yr 7 mo

Originator applications

Brand (NDA) products

YOSPRALARLD

GENUS LIFESCIENCESNDA 20510320162 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
81MG;40MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
325MG;40MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9987231	Jan 02, 2033	in 6 yr 7 mo	U-2324
9539214	Mar 13, 2033	in 6 yr 9 mo	U-1902

FDA approval span

Approval history

First approval

Sep 14, 2016

10 yr ago

Most recent approval

Sep 14, 2016

10 yr ago

All 1 application were approved in 2016.

Brand (NDA) 1100%

Generic (ANDA) 00%

Aspirin; omeprazole — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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