Question 1

Is there a generic for Foscarbidopa; foslevodopa?

Accepted Answer

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

Question 2

What is the reference-listed drug for Foscarbidopa; foslevodopa?

Accepted Answer

VYALEV (NDA 216962, 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 Foscarbidopa; foslevodopa?

Accepted Answer

The Orange Book lists 4 patents against Foscarbidopa; foslevodopa products, with the earliest listed expiry in 2035. 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 Foscarbidopa; foslevodopa have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Foscarbidopa; foslevodopa. 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 Foscarbidopa; foslevodopa are approved?

Accepted Answer

Foscarbidopa; foslevodopa is approved in the following dosage form: solution.

Patent	Expires	In	Type
9446059	Oct 21, 2035	in 9 yr 6 mo	SubstanceProductU-4030
10174061	Oct 21, 2035	in 9 yr 6 mo	ProductU-4030
10730895	Oct 21, 2035	in 9 yr 6 mo	Substance
12251365	Jun 10, 2040	in 14 yr 2 mo	U-4030

Foscarbidopa; foslevodopa

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (4)

Foscarbidopa; foslevodopa — frequently asked questions

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