Expiration dating period extension

An extension of an expiration dating period based on (1) data obtained under a new or revised stability testing protocol that has not been approved in the application or (2) full shelf life data on pilot scale batches using an approved protocol. 

Approved stability protocols are important for the sponsor because they may be used in developing data to support an extension of an approved retest or expiration dating period via annual reports in accordance with 21CFR314.70(d)(5). To change an approved stability protocol or to define one in an application requires a prior approval supplement. 

Can be described in an annual report if criteria set forth in the approved protocol are met. In this case, the extension of the expiration dating period must be based on full long-term stability data obtained from at least three production batches (21 CFR 314.70). 

Unless a new stability protocol has been adopted via a Prior Approval Supplement before the change is made, stability protocols included in drug applications before the 1985 revisions to the NDA regulations (50 FR 7452) may not support the extension of expiration dating periods through annual reports. If the data are obtained under a new or revised stability protocol, a Prior Approval Supplement under 21 CFR 314.70(b) or (g) or 21 CFR 601.12 should be submitted to extend the expiration dating period. 

A U.S. patent application filed on March 1, 1992, and issued on April 1, 1994, would have an expiration date calculated under the provisions for the transition period. The expiration date calculated 17 years from issue would be April 1, 2011. The expiration date calculated 20 years from the first U.S. filing would be March 1, 2012. Because the patent term as calculated 20 years from filing is longer, the expiration date of this patent would be extended to March 1, 2012 thus, the patent will receive an extension of term equal to 11 months. The extension is granted despite the fact that the patent was issued before the passage of the URAA provisions. 

DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION. If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or 505(j) for a new drug may occur after submission of reports of pediatric studies under this section, which were submitted prior to the expiration of the patent (including any patent extension) or the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 505(j)(5)(F), but before the Secretary has determined whether the requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable six month period under subsection (b) or (c) shall be deemed to have been running during the period of delay. 

Iftheissuance of apatent is delayed because of appellate review by the Board of Patent Appeals and Interferences or by a federal court, and the appeal is successful, the patent term is extended for a period of the appeal (up to 5 years). The extension is reduced by any time attributable to appellate review before the expiration of 3 years from the filing date of the application and for the period of time the applicant did not act with "due diligence." 35... 

The permit shall be valid for a period of three years as of its date of issue and shall be understood to be extended for equal and consecutive periods, unless the owner or legal representative reports his wish not to continue his activities prior to expiration of the original term or its extensions. 

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