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FDA Purple Book · Reference family

Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)

Rho(D) Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from CSL Behring AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2004

Reference approved

Reference product

351(a)BLA 125070

Rhophylac Rho(D) Immune Globulin Intravenous (Human)

CSL Behring AG

Approved
Feb 12, 2004
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Rho(D) Immune Globulin Intravenous (Human), in chronological order.

  1. Reference approval

    Approval date of the reference Rho(D) Immune Globulin Intravenous (Human) product.

    22 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)?

No 351(k) biosimilars or interchangeable biosimilars referencing Rho(D) Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.

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