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FDA Purple Book · Reference family

Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection (Anascorp)

Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection is an FDA-licensed reference biologic from Rare Disease Therapeutics, Inc. (RDT). Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2011

Reference approved

Reference product

351(a)BLA 125335

Anascorp Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection

Rare Disease Therapeutics, Inc. (RDT)

Approved
Aug 03, 2011
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection, in chronological order.

  1. Reference approval

    Approval date of the reference Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection product.

    15 yr 1 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    7 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection (Anascorp)?

No 351(k) biosimilars or interchangeable biosimilars referencing Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection are listed in the FDA Purple Book yet.

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