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FDA Purple Book · Reference family

Rubella Virus Vaccine Live (MERUVAX II)

Rubella Virus Vaccine Live is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1969

Reference approved

Reference product

351(a)BLA 101075

MERUVAX II Rubella Virus Vaccine Live

Merck Sharp & Dohme LLC

Approved
Jun 09, 1969
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Rubella Virus Vaccine Live, in chronological order.

  1. Reference approval

    Approval date of the reference Rubella Virus Vaccine Live product.

    57 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for Rubella Virus Vaccine Live (MERUVAX II)?

No 351(k) biosimilars or interchangeable biosimilars referencing Rubella Virus Vaccine Live are listed in the FDA Purple Book yet.

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