[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)] [Notices] [Pages 36928-36929] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2011-15691] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-E-0226] Determination of Regulatory Review Period for Purposes of Patent Extension; BROVANA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for BROVANA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to http://www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product BROVANA (arformoterol tartrate). BROVANA is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BROVANA (U.S. Patent No. 6,589,508) from Sepracor Inc. (now Sunovion Pharmaceuticals, Inc.), and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration and that FDA determine the product's regulatory review period. In a letter dated June 1, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BROVANA represented the first permitted commercial marketing or use of the product. FDA has determined that the applicable regulatory review period for BROVANA is 3,118 days. Of this time, 2,819 days occurred during the testing phase of the regulatory review period, while 299 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: March 26, 1998. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on March 26, 1998. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 12, 2005. The applicant claims December 8, 2005, as the date the new drug application (NDA) for Brovana (NDA 21-912) was initially submitted. However, FDA records indicate that NDA 21-912 was submitted on December 12, 2005. 3. The date the application was approved: October 6, 2006. FDA has verified the applicant's claim that NDA 21-912 was approved on October 6, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 745 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by August 22, 2011. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 20, 2011. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on [[Page 36929]] http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 2, 2011. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2011-15691 Filed 6-22-11; 8:45 am] BILLING CODE 4160-01-P Looks like the boys in Marlborough are trying to get the patent extended for another 2 years if I read this right.
We were told that the Brovana patent is good through 2016. Hope that is true, came from home office. Now if they would start working on combining it with budesonide or Ip we could extend it even more and have something else to sell
Thats BS- drug done in 2014, we lost a case vs generic co.'s and they will launch combo not us, Brovana team is done, this week/month there will be many smart Brovana reps resigning- good luck as this will be a horrible yr for Brovana & Sunovion ask your mgr how the mtg went @ HQ- total mess... PIPs will
Jesus Christ, man, as many times as management has openly lied to the whole sales organization (including you!), you believe everything they tell you? You were a perfect hire then for this organization. Oh, by the way, do a google search on Brovana patent, will you? By the way, all those drug combos with ciclesonide, levalbuterol, ipatroprium, arformoterol, were on the Sepracor pipline chart in 2009. Japs nixed them, and nothing survives from that pool of drugs.
The Sunovion lawyers are actually working instead of sleeping, who knew? But why in the world did it take them so long to file for the patent extension???? Teva's ANDA was submitted back in October 2009! If the Brovana patent extension is approved then the Apr 3, 2012 expiry becomes Apr 18, 2014 and Sunovion can pocket another $240 million over 2 years. Itβs about time someone did something right at this company.
Yawn. this thread pops up every other month. Likely created by reps from the other divisions that sweat their jobs on a daily basis. The Brovana team has been one of the few bright spots of the Sunovion sales force. Sunovion just hired a new leader for Oncology. We have no Oncology drugs approved in the US, but are most likely looking to acquire some drugs. Who do you think is going to be the sales force for the Oncology drugs? Here's a clue.....what starts with B and rhymes with Rovana?
I agree this BS post pops up every other month, and that the Brovana reps are a moneymaker for the company. However, you're dreaming if you think the company will make the Brovana salesforce the Oncology salesforce. What the heck does Brovana have to do with Oncology? It's not the hospital salesforce that people thought it would be. In fact, Brovana reps call on more Primary Care than most of the other salesforces (because that's where a lot of their business is.) It's not a knock at the Brovana salesforce, it's just where much of their business ended up being. Oncology is considered a specialized saleforce and just like the company did with Latuda, they will go outside the company and hire reps with Oncology experience. As much as that sucks, and I agree with most of you that pharma sales is pharma sales and if you can sell one drug, you can sell them all... The unfortunate truth is that Sunovion clearly doesn't feel that way, and the company will yet again go outside rather than giving opportunities to their current willing and able employees. Sad, but true.
Ok I had to post after seeng this... Stop all your ranting and raving just for a second... 1) You work at SUNOVION...Yes SUNOVION....the absolute arm pit of the pharma industry in an industry that is the arm pit of all sales industries... 2) You sell a damn liquid LABA that gets put into a nebulizer... There is not an ounce of real clinical information on what you sell or what you need to know to use this drug!!! A monkey can understand the most difficult parts of this drug regarding the whole PI, disease state and competition. Because of this you have NO REAL VALUE to your customers or to the organization! 3) This industry is dying and you are becoming less effective and have less value every month. You are boasting you are part of the wonderful Brovana team in an industry that is dying and embarrassing to work in due to no real skills needed to hold this job, selling a drug that is like take an OTC aspirin, in a disease state that is basic A&P, and while a good part of your business is through HHC where you have 0 influence. Not to mention you are getting your ass kicked by the competition. So with all of that said...Congratulations on landing and keeping a job selling Brovana at Sunovion. I'm sure your family, friends, and others who you tell this to are proud and impressed! It's nice to be the tallest midget in a room for of basketball players I guess. Seriously, get a clue!!
You forgot to add we make a lot more money!!!! Getting our ass kicked by the competition? Who Perforomist???? BBBBLLLLLAAAAHHHHH
I'm sure your family and friends are proud of you......someone who is full of hate, negative and most likely complains about everything. I feel bad for you...turn that frown upside down!
prob not a day rep, ny is only market where pfmist is beating us- it will be over soon- yay force rankings!