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Orange Book Vol. 42/Supps. 7 and 8 News, Plus an Interesting Type of Claim for VASCEPA

The Vol. 42/Supp. 7 of the FDA’s Orange Book contained only 36 newly listed patents. Maybe July is a slow month? Also, there were no patent delistings.  The Vol. 42/Supp. 8 of the FDA’s Orange Book contained only 33 new patents. Two months in a row with less than forty new patents? Maybe it’s the summer doldrums? There was a delisting request for a patent that was reissued. Ho hum! However, if you are a fan (or not a fan) of listing patents that claim a mechanical part of a drug administration device, there is something for you. Teva Branded Pharmaceutical Products listed 11,395,889 for several of their metered dose asthma inhalers. The ‘889 patent claims a dosage counter for the inhalers. You can see all of the changes by looking at the free “What’s New” for Supp. 8 that is available from a link on my Orange Book Companion home page. “Interesting” Method Claims I have been looking into the Paragraph IV certifications and Section viii statements that Hikma made in their ANDA for Amari

Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes

This posting is late since I am talking about Vol. 42, Supp. 6 of the Orange Book. The data for Supp. 6 was released by the FDA in mid-July. However, I updated my  Orange Book Companion  immediately when the data was released, so my subscribers received the new data on time. Similarly, if you are not a subscriber but enjoy checking out my free  Orange Book Companion  “ What’s New ” each month, that was also ready to view in mid-July. So, what is late? It’s this Supp. 6 news where I discuss a mass delisting of patents for a single product   in which all of the patents had what appears to be overly broad use codes . Please read on.   Supp. 6 added 52 new patents to the FDA’s Orange Book. However, unlike Supp. 5, there were a number of patents that were delisted or were newly tagged as being the subject of a delisting request. Two of four patents listed for Serenity Pharmaceuticals’ NOCTIVA ( desmopressin acetate)   were delisted. Both strengths of NOCTIVA are shown in the Orange Book as

Orange Book Vol. 42/Supp. 5 News

  For those who are interested in month-by-month changes to the patents listed in the Orange Book, and interested in new awards of exclusivity, I posted a link on my public  Orange Book Companion  home page to the free Orange Book Companion “ What’s New ” for Vol. 42, Supp. 5.  Supp. 5 added 44 new patents to the FDA’s Orange Book, and no patents were delisted. However, there was a bumper crop of Patent Term Extensions under 35 USC 156 (eleven, not including one patent that received its second one-year PTE under Sec. 156(e)(2)).  The extended patents have not yet been added to the list of  Sec. 156 extensions  shown at the USPTO. If you want to review the extended patents, just search for the phrase “new expiration date” (without the quotes) in the  What’s New  using your web browser. News has come out recently that Amarin, the Orange Book patent listing champion with 68 patents listed for its 1 gram strength of VASCEPA (icosapent ethyl), is planning a major downsizing in response to s

Orange Book Vol. 42/Supp. 4 News

Orange Book Insights  No. 33 – Orange Book Vol. 42/Supp. 4 News For those who have not checked yet, in mid-May I posted a link to my free Orange Book Companion “What’s New” for Orange Book Vol. 42, Supp. 4 on my public  Orange Book Companion  home page. Supp. 4 added 52 new patents to the FDA’s Orange Book, and showed the delisting of two patents.    One of the delisted patents was  7,323,463 , that had been listed for Allergan’s COMBIGAN ® . The’463 patent had been the subject of a patent delisting request. So the FDA has now acted on that request. The other delisted patent,  9,593,100 , had been listed for Array Biopharma’s MEKTOVI ®  ( binimetinib ) . The MEKTOVI ‘100 patent had not been the subject of a delisting request.   As I categorized the claims of the fifty-two newly listed patents in order to include that information in my  Orange Book Companion , I noticed one set of claims that was particularly interesting. The patent was  11,311,515  listed for an ophthalmic drug called

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!

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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