Purple Book product · Reference 351(a)

Anavip

Crotalidae Immune F(ab')2 (Equine)

351(a)BLA 125488RxLicensed Rare Disease Therapeutics, Inc. (RDT)

View Crotalidae Immune F(ab')2 (Equine) family Label PDF Open on FDA Purple Book

May 06, 2015

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Anavip (Crotalidae Immune F(ab')2 (Equine)) is Rare Disease Therapeutics, Inc. (RDT)'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2015. No biosimilars referencing Anavip are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
May 06, 2015
11 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 06, 2022
4 yr 3 mo ago
Today

Pharmaceutical detail

Strength

MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1860

Product number

001

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Anavip have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Anavip are listed in the FDA Purple Book yet.

What is Anavip's BLA number?

Anavip is licensed under BLA 125488, held by Rare Disease Therapeutics, Inc. (RDT).

When was Anavip approved by the FDA?

Anavip was approved by the FDA on May 06, 2015.

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