Question 1

Is there a generic for Patiromer sorbitex calcium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Patiromer sorbitex calcium?

Accepted Answer

VELTASSA (NDA 205739, VIFOR PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Patiromer sorbitex calcium?

Accepted Answer

The Orange Book lists 7 patents against Patiromer sorbitex calcium 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.

Question 4

Does Patiromer sorbitex calcium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Patiromer sorbitex calcium. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Patiromer sorbitex calcium are approved?

Accepted Answer

Patiromer sorbitex calcium is approved in the following dosage form: powder.

Patent	Expires	In	Type
8216560	Mar 14, 2027	in 9 mo	U-1766
8282913	May 29, 2027	in 11 mo	Product
8147873	Jun 20, 2028	in 2 yr	Product
8337824	May 29, 2030	in 4 yr	SubstanceU-1766
9492476	Oct 08, 2033	in 7 yr 5 mo	U-1766
9925212	Oct 08, 2033	in 7 yr 5 mo	U-1766
11123363	Oct 08, 2033	in 7 yr 5 mo	U-1766

Patiromer sorbitex calcium

Brand (NDA) products · powder

Marketing exclusivity (4)

Listed patents (7)

Patiromer sorbitex calcium — frequently asked questions

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