Purple Book Companion(TM): April Update Announcement & New Features!

  I have updated the beta version of my  Purple Book Companion ™  through April 2022. The FDA's "Purple Book" contains information about approved biologic drugs. This includes patents that some BLA sponsors assert cover their biologics, as well as exclusivities that may prevent the FDA from approving competitive biosimilars of innovator biologics for a certain period of time. My  Purple Book Companion  focuses only on the listed patents and the granted exclusivities. For biologics that have patents and their expiration dates listed in the FDA's Purple Book, the  Purple Book Companion  (" PBC ") additionally provides the title of each patent, the types of claims in each patent, and further includes a link to the text of the patent at the USPTO. So there is no need to individually copy and paste patent numbers into the USPTO's search utility in order to view the patents. Just click the link. New Features : The original version of the  PBC  only had an inde

A New Dosage Form in the Orange Book & New Patents in the Purple Book

New Dosage Form in the Orange Book   One day in mid-August of the year I turned sixteen I came down with what I thought was the worst cold that I had caught in many years. I had a constant runny nose for two weeks straight. That was accompanied by itchy throat and eyes. Finally, after two weeks of this suffering I went to a doctor. After I described this bad cold to him, he asked me if I ever had pollen allergies. When I told him “no” he answered, “well you have them now”!   That started me on a lifetime of allergy treatments that continue to this day. I did not need corrective lenses for many years. However, when I finally needed them I felt that I should not risk using contact lenses due to itchy eyes during allergy season for which eye drops and oral antihistamines were of limited help.   Now the FDA has approved a new type of contact lens on February 25. 2022 that could have “let me have my cake and eat it, too”! It is Johnson & Johnson’s  Acuvue Theravision with Ketotifen  con

Orange Book Companion(R) free "What's New" for Orange Book Vol. 42/Supp. 2 is now available. Plus learn about a new OBC feature!

The free version of the Orange Book Companion 's "What's New" for Vol. 42/Supp. 2 of the FDA's "Orange Book" is now available on the OBC home page . Just click on the prominent " What's New for Patents and Exclusivity " link. Sixty-one new patents were listed in the Orange Book during February, and one patent was delisted. And while you are there, please take a look at free samples of my new  Orange Book Companion  feature. That is  Patents Grouped by Patent Family . Instead of the usual list of patents for a product in numerical order, the patents for a product are grouped by patent family. I used an alternating color scheme of yellow and blue cells in each table so that users can easily see where each family starts and ends. So if you are a fan of drugs whose trade name or generic name starts with "A" you will be able to see exactly what this new feature will give you. Just click on the free sample links, " Tradename-A Fami

Purple Book Companion™ (beta) Announcement

In a January, 2021 Orange Book Insights posting , I reported that the Purple Book for biologic products might soon start including patents. Based upon that news, I was looking forward to creating an enhanced way to look at biologics patents in the same way that my Orange Book Companion ® gives users an enhanced way of looking at Orange Book patents.  So I am now happy to announce the availability of a beta version of my Purple Book Companion ™ (“ PBC ”)! Since this is a beta, it is free for everyone to use. So please take advantage of this offer, and please send any comments, questions, or suggestions that you might have to the email address found on the PBC homepage. Since Purple Book patent listings are fairly new, and were only required on a prospective basis, there are not a lot of such listings. In fact, there are only four products for which patents have been submitted to the FDA: * Avastin® (from Genentech): 22 patents * Humira® (from Abbvie): 65 patents * Lucentis® (from Genen

When are eight 0.5g capsules not equivalent to four 1g capsules?

Orange Book Insights No. 29 – When are eight 0.5g capsules not equivalent to four 1g capsules?  Amarin is still keeping its patent attorneys busy. The Supplement 10 “What’s New” of my Orange Book Companion showed that they listed two more patents for VASCEPA® (icosapent ethyl). Patents Nos. 11,116,742 and 11,154,526 made it 66 patents listed for VASCEPA 1g, and 63 patents listed for VASCEPA 500mg (“half-gram”).  While the ‘742 and ‘526 patents were listed for both the 1g and half-gram strengths of VASCEPA, that new listing started me wondering about the three patents that were listed for the 1g strength but were not listed for the half-gram strength. With 63 patents in common, what was so different about those three patents that Amarin did not list them for the half-gram strength? After all, shouldn’t claims that cover a method of treatment by administering a certain dosage of icosapent ethyl cover the use of both the 1g and half-gram strengths of VASCEPA? Just administer the correc

"What's New" Giveaway Announcement

Orange Book Insights No. 28:  I recently thought of a new way to introduce users of the FDA’s “Orange Book” to my enhanced alternative, the Orange Book Companion ® (“OBC”) . I am doing this by giving something away for free. This is something that everyone who is interested in Orange Book patent and exclusivity information will be able to access, and I intend to continue providing this free information at least through 2022. So, what am I giving away? It is the  OBC ’s monthly “ What’s New ” file, currently based, a s of the Jan. 15, 2022 publication of this blog posting,  on Volume 41, Supplement No. 12 of the  FDA’s monthly PDF Orange Book  Cumulative Supplement . Each month the OBC' s " What's New " will change  as the FDA publishes their monthly Cumulative Supplements . The OBC 's  What’s New  file is a highly enhanced alternative to the “ Patent And Exclusivity Drug Product List ” found in each FDA monthly Cumulative Supplement .   Until now the  OBC ’s month

Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY?

  Orange Book Insights No. 27 –  Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY ? Two nasal sprays containing azelastine hydrochloride were approved under NDA 213872 on June 17, 2021. They were named ASTEPRO ALLERGY (Prod. No. 001) and  Children’s  ASTEPRO ALLERGY (Prod. No. 002). Both have a strength of 0.2055mg/spray. The directions for use are also identical. For example, Prod. No. 001 has the same directions for use by children as Prod. No. 002. Similarly, Prod. No. 002 has the same directions for use by adults as Prod. No. 001. The inactive ingredients of the two versions are identical and listed in the same order. What brought these products to my attention was the Supplement 7 “What’s New” of my Orange Book Companion . The “What’s New” showed that, after the June 17 approval of the both products, three patents were listed for Prod. No. 001, but none for the Prod. No. 002 “children’s” version. The claims of the three listed patents did not