However, FDA was unable to grant final approval to Zydus' ANDA at that time because of the patent issue noted. Therefore, the ANDA was tentatively approved. The RLD upon which Zydus had based its ANDA, AstraZeneca's Tagrisso Tablets,
40 mg and 80 mg, is subject to periods of patent protection. The following patents and expiration dates are currently listed in the Agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”): 8,946,235 (the '235 patent; Exp Date: August 8, 2032), 9,732,058 (the '058 patent; Exp. Date: July 25, 2032),
and 10,183,020 (the '020 patent; Exp Date: January 2, 2035)
With respect to the '235 and '058 patents, Zydus' ANDA contains paragraph III certifications to each of the patents under section 505(j)(2)(A)(vii)(III) of the FD&C Act stating that Zydus will not market Osimertinib Tablets, 40 mg and 80 mg, prior to the expiration of the patents. Therefore, final approval of Zydus' ANDA may not be granted pursuant to section 505(j)(5)(B)(ii) of the FD&C Act until the '235 and '058 patents have expired, currently August 8, 2032.
Zydus' ANDA also contains a paragraph IV certification to the '020 patent under section 505(j)(2)(A)(vii)(IV) of the FD&C Act stating that the patent is invalid, unenforceable, or will not be infringed by your manufacture, use, or sale of Osimertinib Tablets, 40 mg and 80 mg, under this ANDA.
Zydus has notified the Agency that Zydus complied with the
requirements of section 505(j)(2)(B) of the FD&C Act. Litigation was initiated within the statutory 45-day period against Zydus for infringement of the '020 patent in the United States District Court for the District of Delaware [AstraZeneca AB and AstraZeneca Pharmaceuticals LP v. Alembic Pharmaceuticals Limited, Alembic Global Holding SA, Alembic Pharmaceuticals, Inc., MSN Laboratories PVT. LTD., MSN Pharmaceuticals Inc., Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Ltd., Civil Action No. 20-00202].
Therefore, final approval cannot be granted until:
1. a. the expiration of the 7.5-year period provided for in sections 505(j)(5)(B)(iii) and 505(j)(5)(F)(ii) of the FD&C Act, b. the date the court decides1 that the '020 patent is invalid or not infringed (see sections 505(j)(5)(B)(iii)(I), (II), and (III) of the FD&C Act), or c. the '020 patent has expired, and 2. The Agency is assured there is no new information that would affect whether final approval should be granted. And Zydus' generic version is not listed in the orange book (below) as of January 23, 2024.
The one not discussed in the tentative approval letter that FDA sent to Zydus is 11524951. This patent was submitted to FDA on January 11, 2023!! (The rest were submitted to FDA in 12/11/2015-02/12/2019), wherein Zydus submitted its ANDA on November 13, 2019.
