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FDA Purple Book · Reference family

Timothy Grass Pollen Allergen Extract (Grastek)

Timothy Grass Pollen Allergen Extract is an FDA-licensed reference biologic from ALK - Abello A/S. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2014

Reference approved

Reference product

351(a)BLA 125473

Grastek Timothy Grass Pollen Allergen Extract

ALK - Abello A/S

Approved
Apr 11, 2014
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Timothy Grass Pollen Allergen Extract, in chronological order.

  1. Reference approval

    Approval date of the reference Timothy Grass Pollen Allergen Extract product.

    12 yr 4 mo ago

Frequently asked questions

Are there biosimilars approved for Timothy Grass Pollen Allergen Extract (Grastek)?

No 351(k) biosimilars or interchangeable biosimilars referencing Timothy Grass Pollen Allergen Extract are listed in the FDA Purple Book yet.

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