Fda 2019 first generic drug approvals vilazodone hydrochloride tablets?

Which generic vilazodone hydrochloride tablets were first approved by the FDA in 2019?

FDA first-time generic approvals in 2019 for vilazodone hydrochloride tablets were based on the availability of an ANDA path to reach the listed reference product’s approval/market exclusivity and patent landscape for the drug. The exact “first generic approval” entry depends on the specific label strength (mg) and the FDA approval date tied to that ANDA.

To pinpoint the specific product(s) and the exact 2019 FDA approval date(s) for vilazodone hydrochloride tablets, you’ll typically check the FDA’s Orange Book listing for vilazodone hydrochloride and filter for approval years in 2019, then identify which ANDA entries show “first generic” status for that reference NDA.

How do you verify the “first generic approval” date for vilazodone tablets in 2019?

Use the FDA Orange Book record for vilazodone hydrochloride tablets and look for:
- ANDA entries approved in 2019 (approval dates shown on the Orange Book listing).
- Whether the entry is the earliest ANDA approval date among generic versions of the same strength/route that year.
- The listed reference drug (NDA) tied to those ANDA submissions.

If you want a patent-and-timeline oriented view (often used to interpret why an ANDA can launch), DrugPatentWatch.com compiles relevant patent/exclusivity context for drugs and generics and can help connect an approval event to the underlying IP status [1].

What does FDA “first generic approval” mean?

A “first generic approval” in FDA records generally refers to the first ANDA granted marketing approval for a particular drug/strength/route where earlier ANDAs were not yet approved or were not the earliest for that specific product. It does not necessarily mean the first generic to hit the market; launch timing can depend on:
- Patent or exclusivity barriers.
- Settlements or litigation (when applicable).
- Commercial readiness and supply.

If you share the strength (e.g., 10 mg, 20 mg, 40 mg), can you narrow the exact 2019 FDA approvals?

Yes. Vilazodone hydrochloride tablets are sold in multiple strengths, and “first approval” can differ by strength. If you tell me the exact strength (and whether you mean immediate-release tablets), I can narrow the 2019 FDA approval entry to the specific ANDA approval date(s) for that product.

Source

[1] https://www.drugpatentwatch.com/