Fdas approved drug products with therapeutic equivalence evaluations orange book identifies drug products approved on the basis of. One of the most significant obstacles to drug competition is a patent listed in fda s orange book. About sanofi sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients needs. Improper listing of insulinpen patents in the orange book. Mercks drug is mk1293, an investigational followup biologic insulin glargine candidate for the treatment of. Listing a patent in the orange book allows the drug manufacture to trigger an automatic 30month stay of fda approval of any application for a competing drug product. Basaglar is similar to the insulin glargine injection lantus, and the approval of basaglar relied in part on the fdas finding of safety and effectiveness for lantus. Claims against sanofi for improper orange book listings and sham. However, fda guidance also states that innovators must not include. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and. Claims that sanofi improperly listed patent, engaged in. Antitrust liability risk when listing patents in orange. Lantus is a longacting manmadeinsulin used to control high blood sugar in adults with diabetes mellitus.
The orange book has long been a reliable resource for information about fda approved drugs. Court finds sanofi improperly listed insulin device patent. Sanofi decision presents opportunities to clear the patent. In december 2015, the food and drug administration fda approved the longacting human insulin analog basaglar insulin glargine injection. Court of appeals for the first circuit recently ruled that sanofi could potentially be held liable for an antitrust violation for improperly listing an insulin delivery devicerelated patent in the u. In re lantus direct purchaser antitrust litigation feb. It is not known if lantus is safe and effective in children less than 6 years of age with type 1 diabetes. Mercks nda included a paragraph iv certification challenging all of the 10 sanofi patents listed in the fda orange book for lantus and lantus solostar products. As such, theyre not interchangeable with the brandname products lantus. Orange book listing of drug delivery device patents after in re lantus, february 2020 1. The appellate panel also rejected sanofis argument that fdas regulations require listing in the orange book any patents that contain integral components of an approved drug product.
The lantus court also specifically noted the fda s refusal to address the issue on numerous occasions and reasoned that orange book listing of drug delivery devices without a drug was still an open question, such that either listing or not listing such devices could be considered reasonable. Based, in part, on their original contention that the fda approved the lantus solostar as a package change, the plaintiffs alleged in their amended complaint that it was obvious that the 864 patent should not have been listed in the orange book. The recent and upcoming expiration of patent protection for a number of insulin preparations will open up the insulin market worldwide to manufacturers of insulin copies or biosimilars, or as they are currently called due to us food and drug administration fda regulations, followon insulins table 1. Requirements, benefits, and possible consequences of. Failing to find sufficient facts pleading sham litigation. The mere listing of a patent can delay competition for months, or even years, and drive up expense for competitors. The lantus court also specifically noted the fdas refusal to address the issue on numerous occasions and reasoned that orange book listing of drug delivery devices without a drug was still an open question, such that either listing or not listing such devices could be considered reasonable. Sanofi reported that in the nda, merck included a paragraph iv certification challenging the patents and listed in the fda orange book for lantus and lantus. Lantus pharmacokinetics absorption bioavailability. Because of this, these biologics are not currently approved as interchangeable by the orange book, the fdas resource for therapeutic equivalence.
List of approved drug products containing glargine in the fda orange book on. Also in honor of this event, the fda issued a new version of volume 40 of the orange book in pdf format. The orange book has long been a reliable resource for information about fdaapproved drugs. The fda, for its part, will not answer many of these questions. Fda granted approval for eli lilly and companys basaglar insulin glargine injection, a longacting human insulin product indicated for glycemic control in patients with diabetes mellitus. Thus, the purple book is the orange book for biologics and can be used similarly to determine which biologic is biosimilar to or interchangeable with an originator 19,27. Improper listing of insulinpen patents in the orange book patently. This classaction antitrust decision from the 1st circuit reversed a lower court dismissal holding that consumers had alleged sufficient injury based upon sanofis improper listing of patents in the fda orange book approved drug products with therapeutic equivalence evaluations. In 2007, the fda accepted sanofis snda for the solostar and categorized it as a change to lantuss labeling or container. According to the fdas orange book, patent expirations on sanofis lantus and lantus solostar range from 2023 to 2028.
Except, for some reason, sanofis lantus and lantus solostar insulin glargine products are still showing up in an eob search for insulin. Sanofi patent included in the orange book for the companys lantus solostar. As to the orange book claim, fda regulations provide that, when filing a new drug application nda the applicant should include patents that claim the drug or a. Sanofi aims to block mercks lantus biosimilar biopharma. In applying for fda approval to market new drugs, drug manufacturers must list all patents that claim the drug or the method of using the drug in fdas orange book. The applicant may file a citizen petition and request guidance from fda. Basaglar and lantus cannot be freely substituted for each other. Drug delivery devices in the fda orange book after in re. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug. Listing the medical device part of a combination product. In a historic shift, fda transitions regulatory pathway for insulin and. Healthcare providers will be able to find these products in the purple book rather than the orange book from which they will be removed. With its original application, sanofi submitted a patent for listing in the orange book, which claimed the drug insulin glargine, and which was sold only in vials or cartridges for reusable. Antitrust liability risk when listing patents in orange book.
No crossover studies between lantus and basaglar have been published. Consistent with its ministerial role in orange book patent listing, fda. It is not known if lantus is safe and effective in children with type 2 diabetes. Lantus is not for use to treat diabetic ketoacidosis. Lantus fda prescribing information, side effects and uses. Orange book patents could face more challenges after appellate ruling.
Sanofi submitted patents for the lantus solostar, an insulin glargine disposable injector pen device, for orange book listing in 20. The electronic availability of the orange book brings this valuable tool to the web for healthcare. The regulation of followon biological products via 505b2 strike while the iron is hot. Murky fda device guidance kills sanofi antitrust suit law360. Sanofi ruling makes getting drugs on fda approved list. First circuit opines on listing device patents in the orange book march 16, 2020 by sara w. Sanofiaventis first obtained fda approval to market insulin glargine under the brand name lantus in 2000, and filed a patent for the drug set to expire in 2014.
Lantus followon biologic faces additional legal barriers. With its original application, sanofi submitted a patent for listing in the orange book, which claimed the drug insulin glargine, and which was. Drug delivery devices in the fda orange book after in re lantus. As to the orange book claim, fda regulations provide that, when. The fdas purple book lists all biologics with notations on which medications are originators, biosimilars, or interchangeables. I have a question about that pending with the orange book staff. Orange book patents could face more challenges after appellate. Following injection into subq tissue, neutralization of insulin glargine solution results in formation of microprecipitates from which the drug is slowly released. Sanofi improperly listed lantus patent in fdas orange book, appeals court finds first circuit reverses dismissal of direct purchasers suit alleging improper listing of patent on device drive mechanism delayed competition. In a holding that could significantly broaden the antitrust inquiry in the context of the hatchwaxman regulatory scheme, on february, 2020, the u. Fda tentatively approves mercks copycat of sanofis lantus. The plaintiffs repeated their assertion that since the 864 patent does not expressly mention lantus, lantus solostar, or insulin glargine, it is improper to list it in the orange book as claiming lantus solostar. Court of appeals for the first circuit held, in a direct purchaser antitrust action, that an innovative pharmaceutical company marketing an injectable drug product had improperly listed in fdas orange book a patent claiming a mechanism used in the drugs.
Sanofi tries to stop lantus biosimilar by getting supreme. The lawsuit was the result of the new drug application nda for the product. Sanofi sues mylan over lantus patents, seeking to defend. Basaglar is similar to the insulin glargine injection lantus, and the approval of basaglar relied in part on the fda s finding of safety and effectiveness for lantus. The us court of appeals for the first circuit held that pharmaceutical companies that wrongly list patents in fdas orange book must prove they acted in good faith to avoid antitrust liability. Claims against sanofi for improper orange book listings. Sanofi alleges that merck is infringing on 2 patents for a followon biologic to insulin glargine lantus. Approved drug products with therapeutic equivalence. The court found that the fda has expressly interpreted drug products which must be listed in the orange book to include prefilled drug delivery systems and the plaintiffs conceded that the lantus solostar was sold as a prefilled drug delivery system. On january 10, 2018, in in re lantus direct purchaser antitrust litig. First circuit permits antitrust claims for improperly. Id see also in re lantus direct purchaser antitrust litig. Food and drug administrations fda orange book ob for. Glargine fda orange book approved drug product list.
The potential attraction of these new insulins is clear, especially with the. The regulation of followon biological products via 505b. In 20, sanofi submitted patents associated with the solostar to the fda for listing in the orange book. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for lantus insulin glargine skip to. On march 23, 2020, fda removed from the orange book the listings for biological products that have been approved in applications under section 505 of the. Court finds sanofi improperly listed insulin device patent in fdas. A new breed of antitrust challenges to fdas orange book. While the complaint references a number of those patents, plaintiffs pare their. The fda clearly approved solostar as a disposable insulin injection device and therefore a drug product for orange book purposes. The principal questions on appeal are whether one of those patents was improperly submitted and whether that triggers potential antitrust liability, judge william j.
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