Is there a generic for Citric acid; magnesium oxide; sodium picosulfate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Citric acid; magnesium oxide; sodium picosulfate, referencing the brand CLENPIQ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Citric acid; magnesium oxide; sodium picosulfate?

CLENPIQ (NDA 209589, FERRING PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Citric acid; magnesium oxide; sodium picosulfate?

The Orange Book lists 7 patents against Citric acid; magnesium oxide; sodium picosulfate products, with the earliest listed expiry in 2028. 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 Citric acid; magnesium oxide; sodium picosulfate are approved?

Citric acid; magnesium oxide; sodium picosulfate is approved in the following dosage forms: for solution, solution.

FDA Orange Book · active-ingredient family

Citric acid; magnesium oxide; sodium picosulfate

Citric acid; magnesium oxide; sodium picosulfate: 2 brands, 1 generic; first approved Jul 16, 2012; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Oct 10, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 10, 2028

in 2 yr 3 mo

Originator applications

Brand (NDA) products

CLENPIQRLDRS

FERRING PHARMS INCNDA 2095892017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12GM/BOT;3.5GM/BOT;10MG/BOT	SOLUTION	ORAL	Rx	—

PREPOPIKRLD

FERRING PHARMS INCNDA 2025352012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12GM/PACKET;3.5GM/PACKET;10MG/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (1)

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACIDRS

HETERO LABS LTD VANDA 2127892022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION	ORAL	Rx	—

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
8450338	Oct 10, 2028	in 2 yr 3 mo	Product
8481083	Oct 10, 2028	in 2 yr 3 mo	Product
11191753	Jun 23, 2034	in 8 yr 1 mo	U-3261
12576072	Jun 23, 2034	in 8 yr 1 mo	ProductU-3261
10624879	Jun 23, 2034	in 8 yr 1 mo	Product
9827231	Jun 26, 2034	in 8 yr 1 mo	ProductU-2162
12458634	Jan 27, 2038	in 11 yr 9 mo	Product

FDA approval span

Approval history

First approval

Jul 16, 2012

14 yr 2 mo ago

Most recent approval

Jul 18, 2022

4 yr ago

Approvals span 2012–2022 across 3 FDA applications.

Brand (NDA) 267%

Generic (ANDA) 133%

Citric acid; magnesium oxide; sodium picosulfate — 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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