Biologic Drug IPR Petitions

Biologic Drug IPR Petitions

by | Jun 19, 2025

  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...
Biologic Drug IPRs by Reference Product

Biologic Drug IPRs by Reference Product

by | Jun 19, 2025

  Biologic Drug IPR Petitions include IPR petitions relating to CDER-listed / 505(b)(2) biologic products.  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...
Biologic Drug IPRs and Number of Patents Challenged

Biologic Drug IPRs and Number of Patents Challenged

by | Jun 19, 2025

  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...

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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