Is there a generic for Morphine sulfate; naltrexone hydrochloride?

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

What is the reference-listed drug for Morphine sulfate; naltrexone hydrochloride?

EMBEDA (NDA 022321, ALPHARMA PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Morphine sulfate; naltrexone hydrochloride?

The Orange Book lists 7 patents against Morphine sulfate; naltrexone hydrochloride products, with the earliest listed expiry in 2027. 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 Morphine sulfate; naltrexone hydrochloride are approved?

Morphine sulfate; naltrexone hydrochloride is approved in the following dosage form: capsule, extended release.

FDA Orange Book · active-ingredient family

Morphine sulfate; naltrexone hydrochloride

Morphine sulfate; naltrexone hydrochloride: 1 brand, 0 generics; first approved Aug 13, 2009; on patent until Jun 19, 2027.

On patentHas discontinued products

Generic status & protection

Protected until Jun 19, 2027 (earliest listed patent expiry).

Earliest patent expiry Jun 19, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 19, 2027

in 11 mo

Originator applications

Brand (NDA) products

EMBEDARLD

ALPHARMA PHARMSNDA 02232120096 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8158156	Jun 19, 2027	in 11 mo	U-1510
7682633	Jun 19, 2027	in 11 mo	U-1510
8846104	Jun 19, 2027	in 11 mo	Product
7682634	Jun 19, 2027	in 11 mo	Product
8877247	Jun 19, 2027	in 11 mo	Product
7815934	Dec 12, 2027	in 1 yr 5 mo	Product
8623418	Nov 07, 2029	in 3 yr 4 mo	U-1640

FDA approval span

Approval history

First approval

Aug 13, 2009

17 yr 2 mo ago

Most recent approval

Aug 13, 2009

17 yr 2 mo ago

All 1 application were approved in 2009.

Brand (NDA) 1100%

Generic (ANDA) 00%

Morphine sulfate; naltrexone hydrochloride — 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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