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FDA Purple Book · Reference family

elapegademase-lvlr (Revcovi)

elapegademase-lvlr is an FDA-licensed reference biologic from Chiesi USA, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2018

Reference approved

Reference product

351(a)BLA 761092

Revcovi elapegademase-lvlr

Chiesi USA, Inc.

Approved
Oct 05, 2018
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for elapegademase-lvlr, in chronological order.

  1. Reference approval

    Approval date of the reference elapegademase-lvlr product.

    7 yr 9 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    8 mo ago

Frequently asked questions

Are there biosimilars approved for elapegademase-lvlr (Revcovi)?

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

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