Online, Flash Drive & Two-Volume Book Set
Products and services from Bruce A. Pokras'
Blazing Dawn Software
(Vol. 39, Supp. 09)
|June 20, 2019: The Orange Book ArchiveTM
is now updated through the end of 2018 in tables alphabetical by
tradename and generic name. Available only to subscribers, the
OBA has expired patents and exclusivities going back to the dawn of
Hatch-Waxman. Tables alphabetical by company name and a table of every
expired patent with the product(s) for which they were listed will be
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 applicant's eligibility for 180-day exclusivity. All ANDA applicants must still provide a 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.
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:
Oct. 6, 2019: "Raising Arizona" as a metaphor for a disappearing extended Orange Book patent
July 31, 2019: A disappearing Pediatric Exclusivity and other musings about the June 2019 Orange Book supplement
July 7, 2019: Now you see them, now you don't: catch those expiration date issues before your patent or exclusivity disappears!
June 5, 2019: New cocaine patent, no exclusivity for "real world data" and other insights into Orange Book Supp. 4.
May 16, 2019: FDA releases guidance for choosing ANDA or 505(b)(2) route for drug approval
"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: October 22, 2019
© 2001-2019 Bruce A. Pokras, All rights reserved worldwide