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FDA Purple Book · Reference family

Tuberculin, Purified Protein Derivative (Aplisol)

Tuberculin, Purified Protein Derivative is an FDA-licensed reference biologic from Endo Operations Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1998

Reference approved

Reference product

351(a)BLA 103782

Aplisol Tuberculin, Purified Protein Derivative

Endo Operations Limited

Approved
Apr 20, 1998
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Tuberculin, Purified Protein Derivative, in chronological order.

  1. Reference approval

    Approval date of the reference Tuberculin, Purified Protein Derivative product.

    28 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for Tuberculin, Purified Protein Derivative (Aplisol)?

No 351(k) biosimilars or interchangeable biosimilars referencing Tuberculin, Purified Protein Derivative are listed in the FDA Purple Book yet.

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