Question 1

Is there a generic for Venetoclax?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Venetoclax, referencing the brand VENCLEXTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Venetoclax?

Accepted Answer

VENCLEXTA (NDA 208573, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Venetoclax?

Accepted Answer

The Orange Book lists 10 patents against Venetoclax products, with the earliest listed expiry in 2030. 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 Venetoclax have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Venetoclax. 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 Venetoclax are approved?

Accepted Answer

Venetoclax is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9174982	May 26, 2030	in 4 yr	U-2537
8546399	Jun 27, 2031	in 5 yr 1 mo	SubstanceProduct
10730873	Nov 21, 2031	in 5 yr 6 mo	Substance
8722657	Jan 29, 2032	in 5 yr 8 mo	Substance
11369599	May 23, 2032	in 6 yr	Product
11413282	Sep 06, 2033	in 7 yr 4 mo	U-3412
11590128	Sep 06, 2033	in 7 yr 4 mo	U-3548
9539251	Sep 06, 2033	in 7 yr 4 mo	U-2538
10993942	Sep 06, 2033	in 7 yr 4 mo	U-3114
11110087	Sep 06, 2033	in 7 yr 4 mo	U-3222

Venetoclax

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Marketing exclusivity (3)

Listed patents (10)

Venetoclax — frequently asked questions

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