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Purple Book reference family · 351(a) biologic

ranibizumab (Lucentis)

ranibizumab is an FDA-licensed reference biologic from Genentech, Inc., with 3 approved follow-on biologics.

351(a) biologicBLA 125156 Genentech, Inc.
Biosimilars
0
Interchangeables
3
Listed patents
11
Reference approved
2016

Reference product

Originator biologic
351(a)BLA 125156

Lucentis ranibizumab

Genentech, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
11 listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference ranibizumab product.

    10 yr 1 mo ago

  2. Patent 6,716,602 expires

    Published Purple Book patent expiration.

    4 yr 11 mo ago

  3. Patent 6,828,121 expires

    Published Purple Book patent expiration.

    4 yr 3 mo ago

  4. Patent 9,688,775 expires

    Published Purple Book patent expiration.

    3 yr 9 mo ago

  5. Patent 6,921,659 expires

    Published Purple Book patent expiration.

    3 yr ago

  6. Patent 8,383,773 expires

    Published Purple Book patent expiration.

    2 yr 10 mo ago

  7. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  8. Patent 10,421,984 expires

    Published Purple Book patent expiration.

    in 7 yr 1 mo

  9. Patent 9,765,379 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  10. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  11. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  12. Patent 10,112,994 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

Biosimilars & interchangeables for ranibizumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing ranibizumab.
ProductProper nameApplicantTypeBLAApproved
Byoovizranibizumab-nunaSamsung Bioepis Co., Ltd.Interchangeable761202
Cimerliranibizumab-eqrnSandoz Inc.Interchangeable761165
Nufymcoranibizumab-leykFormycon AGInterchangeable761473

Published patents

Purple Book patent list
Published Purple Book patents for ranibizumab.
PatentExpiresIn
6,716,6024 yr 11 mo ago
6,828,1214 yr 3 mo ago
9,688,7753 yr 9 mo ago
6,921,6593 yr ago
8,383,7732 yr 10 mo ago
8,574,869in 1 yr 10 mo
10,421,984in 7 yr 1 mo
9,765,379in 7 yr 7 mo
10,017,732in 7 yr 7 mo
10,829,732in 7 yr 7 mo
10,112,994in 9 yr 3 mo

ranibizumab: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for ranibizumab.

Related FDA reference tools

Agent CTA Background

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