Online, Flash Drive & Two-Volume Book Set
Products and services from Bruce A. Pokras'
Blazing Dawn Software
(Vol. 39, Supp. 04)
|Dec. 30, 2018:
My last piece of catching up with the FDA's additions to its monthly
raw data over the last 14 years. Patents in the Orange Book Companion will now
include a DLR* (delisting
requested) tag if the NDA holder has requested that the FDA delist the
patent. The patent will remain listed in the Orange Book if the FDA
determines that its delisting would adversely affect an ANDA
eligibility for 180-day exclusivity. All ANDA applicants must still
patent certification for the patent, but 505(b)(2) applicants no longer need to do so. Try searching the working sample files for "DLR" (not case sensitive) to see examples.
Nov. 4, 2018: More catching up after my 14 year absence: I have now added patent submission dates for those patents that have them in the Electronic Orange Book. Please look for the "Pat. Sub. Date(s)" line for each patent in the working samples.
Orange Book Patent Listing Champions:AFREZZA, BYDUREON PEN,
and HYSINGLA (lower strengths) each have 36 patents listed in the Orange Book!
Samples of Files
Actual working samples showing
products whose next patent expiration is in:
May 16, 2019: FDA releases guidance for choosing ANDA or 505(b)(2) route for drug approval
April 29, 2019: Comments on FDA's March 2019 Orange Book raw data
April 3, 2019: Comments on the FDA's February 2019 Orange Book raw data
Feb. 27, 2019: Happy Orange Book New Year! Comments on FDA raw data for Vol. 39, Supp. 1.
Jan. 26, 2019: Comments on FDA raw data for Vol. 38, Supp. 12
Jan. 10, 2019: Do Not Neglect Patent Listings for the Discontinued Strengths of Your Marketed Drugs
"King Love" by the Allures was recently used in an episode of Netflix's
"Master of None" starring Aziz Ansari. In Season 2, Episode 5, Ansari's
character, Dev Shah, is at a bar with a date. As he and his date are
talking, King Love is playing softly in the background.
Download song samples and full length MP3's of Melron's "Philly Sound" music from the late 50's and early 60's. Then purchase the CD or download or stream your favorites from Apple iTunes or the Apple Music service
Orange Book Companion
Two-Volume Book Set
To be revived!
Please let me know if you would be interested by sending an email to the contact address at the bottom of this page.
In the meantime, read all about it.
Blazing Dawn Software
Economical software for Mac and Windows.
Search for and download US, EP, PCT and many international patents and published applications with Patent GrabberTM. Explore many of Patent Grabber's additional features in its free trial mode.
Still need to write checks? Try out ChecksQuickTM.
All trademarks in the Patent & Exclusivity Information and in the Reference Listed Drug information are the property of the various drug companies who market the products, or their licensors.
Latest Update: April 18, 2019
© 2001-2019 Bruce A. Pokras, All rights reserved worldwide