Biologic Drug IPR Petitions include IPR petitions relating to CDER-listed biologic products and drugs for which follow-on products are approved under the 505(b)(2) pathway, such as insulin. IPR petitions relating to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent No. 6,331,415 (a “Cabilly” patent)) are not included.
Data shown only for the subset of CDER-listed biologic drugs with the greatest number of Biologic Drug IPRs: Herceptin®, Eylea®, Rituxan®, Lantus®, Humira®, Keytruda®, Ajovy®, and Emgality®.
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