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FDA Purple Book · Reference family

Rabies Immune Globulin (Human) (Bayrab, Hyperrab)

Rabies 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

1974

Reference approved

Reference product

351(a)BLA 101144

Bayrab, Hyperrab Rabies Immune Globulin (Human)

Grifols Therapeutics LLC

Approved
Jun 12, 1974
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    52 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for Rabies Immune Globulin (Human) (Bayrab, Hyperrab)?

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

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