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Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MENHIBRIX)

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2012

Reference approved

Reference product

351(a)BLA 125363

MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

GlaxoSmithKline Biologicals

Approved
Jun 14, 2012
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine, in chronological order.

  1. Reference approval

    Approval date of the reference Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine product.

    14 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MENHIBRIX)?

No 351(k) biosimilars or interchangeable biosimilars referencing Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine are listed in the FDA Purple Book yet.

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