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FDA Purple Book · Reference family

Rho(D) Immune Globulin (Human) (Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose)

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

0

Biosimilars

0

Interchangeables

0

Listed patents

1971

Reference approved

Reference product

351(a)BLA 101141

Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose Rho(D) Immune Globulin (Human)

Grifols Therapeutics LLC

Approved
Jun 11, 1971
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    55 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for Rho(D) Immune Globulin (Human) (Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose)?

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

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