high risk) kymriah (tisagenlecleucel)acute lymphoblastic leukemia lamisil (terbinafine)fungal infections lescol (fluvastatin)hypercholesterolemia6652007−8% lioresal (baclofen)spasticity lotrel (amlodipine/benazepril)hypertension7482007−34% lucentis (ranibizumab)age-related macular degeneration2,398201217% ludiomil (maprotiline)major depressive disorder mayzent (siponimod) treatment for secondary progressive multiple sclerosis (spms) fda approved march 26, 2019 mellaril (thioridazine)schizophrenia myfortic (mycophenolic acid)prevention of transplant rejection579201212% navoban (tropisetron)chemotherapy-induced nausea and vomiting odomzo (sonidegib)locally advanced basal cell carcinoma ritalin (methylphenidate)adhd55420121% sandimmune/neoral (ciclosporin)prevention of transplant rejection8212012−9% sandostatin (octreotide)acromegaly1,51220125% sertraline sandoz (sertraline hydrochloride) depression, obsessive-compulsive disorder, panic disorder generic form of sertraline. signifor (pasireotide) cushing's disease simulect (basiliximab)prevention of transplant rejection sirdalud (tizanidine)spasticity spersallerg (antazoline/tetrahydrozoline)allergic conjunctivitis stalevo (carbidopa/levodopa/entacapone)parkinson's disease tasigna (nilotinib)chronic myelogenous leukemia (first-line treatment)998201239%nice formulary approval, january 2012 tegretol (carbamazepine)epilepsy, bipolar disorder41320076% tekamlo (aliskiren/amlodipine)hypertension tekturna/rasilez (aliskiren)hypertension termalgin (paracetamol)fever, mild pain tobi (tobramycin)prevention of pseudomonas aeruginosa infection in cystic fibrosis350 (us only)2012teva introduced generic in the us in 2013 tofranil (imipramine)major depressive disorder, enuresis trileptal (oxcarbazepine)epilepsy, bipolar disorder690 (us only)2007teva introduced generic in 2008 tyzeca/sebivo (telbivudine)chronic hepatitis b visudyne (verteporfin)age-related macular degeneration (wet form) voltaren (diclofenac)acute pain, inflammatory disorders (such as rheumatoid arthritis)759 (excl. otc)2012−4% zometa (zoledronic acid)prevention of bone fractures in cancer patients1,2882012−13% xolair (omalizumab)moderate-to-severe asthma not controlled by inhaled steroidschronic idiopathic urticaria50420124% zaditen (ketotifen)asthma, allergic conjunctivitis consumer health benefiber bialcol alcohol buckley's cold and cough formula bufferin chesteze comtrex cold and cough denavir/vectavir desenex doan's pain relief ex-lax excedrin fenistil gas-x habitrol keri skin care lamisil foot care lipactin herpes symptomatic treatment maalox nicotinell no-doz quinvaxem (pentavalent vaccine) otrivine prevacid 24hr savlon tavist theraflu vagistat tixylix voltaren in january 2009, the united states department of health and human services awarded novartis a $486 million contract for construction of the first us plant to produce cell-based influenza vaccine, to be located in holly springs, north carolina. the stated goal of this program is the capability of producing 150,000,000 doses of pandemic vaccine within six months of declaring a flu pandemic. in april 2014, novartis divested its consumer health section with $3,5 billion worth of assets into a new joint venture with glaxosmithkline, named gsk consumer healthcare, of which novartis will hold a 36,5% stake. in march 2018, gsk announced that it has reached an agreement with novartis to acquire novartis' 36.5% stake in their consumer healthcare joint venture for $13 billion (£9.2 billion). pet care interceptor (milbemycin oxime), oral worm control product sentinel flavor tabs (milbemycin oxime, lufenuron), oral flea control product deramaxx (deracoxib), oral treatment for pain and inflammation from osteoarthritis in dogs capstar (nitenpyram), oral tablet for flea control milbemax (milbemycin oxime, praziquantel), oral worm treatment program (lufenuron), oral tablet for flea control livestock acatalk duostar (fluazuron, ivermectin), tick control for cattle clik (dicyclanil), blowfly control for sheep denagard (tiamulin), antibiotic for the treatment of swine dysentery associated with brachyspira (formerly serpulina or treponema) fasinex (triclabendazole), oral drench for cattle that is used for the treatment and control of all three stages of liver fluke virashield, for use in healthy cattle, including pregnant cows and heifers, as an aid in the prevention of disease caused by infectious bovine rhinotracheitis (ibr), bovine virus diarrhoea (bvd type 1 and bvd type 2), parainfluenza type 3 (pi3), and bovine respiratory syncytial (brsv) viruses bioprotection (insect and rodent control) actara (thiamethoxam) atrazine (atrazine) larvadex (cyromazine) neporex (cyromazine) oxyfly (lambda-cyhalothrin) virusnip (potassium monopersulfate) controversies and criticism challenge to india's patent laws novartis fought a seven-year, controversial battle to patent gleevec in india, and took the case all the way to the indian supreme court, where the patent application was finally rejected. the patent application at the center of the case was filed by novartis in india in 1998, after india had agreed to enter the world trade organization and to abide by worldwide intellectual property standards under the trips agreement. as part of this agreement, india made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, afterwards they were, albeit with restrictions. these changes came into effect in 2005, so novartis' patent application waited in a "mailbox" with others until then, under procedures that india instituted to manage the transition. india also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application. the patent application claimed the final form of gleevec (the beta crystalline form of imatinib mesylate).: 3 in 1993 before india allowed patents on products, novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in india. the key differences between the two patent applications were that the 1998 patent application specified the counterion (gleevec is a specific salt - imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of gleevec - the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is separate from processes by which the drug itself is formulated into pills or capsules) - while the 1993 patent application did not. the solid form of imatinib mesylate in gleevec is beta crystalline. as provided under the trips agreement, novartis applied for exclusive marketing rights (emr) for gleevec from the indian patent office and the emr was granted in november 2003. novartis made use of the emr to obtain orders against some generic manufacturers who had already launched gleevec in india. novartis set the price of gleevec at us$2666 per patient per month; generic companies were selling their versions at us$177 to 266 per patient per month. novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch. when examination of novartis' patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling gleevec in india and by advocacy groups. the application was rejected by the patent office and by an appeal board. the key basis for the rejection was the part of indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. that section, paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy." at one point, novartis went to court to try to invalidate paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated trips. novartis lost that case and did not appeal. novartis did appeal the rejection by the patent office to india's supreme court, which took the case. the supreme court case hinged on the interpretation of paragraph 3d. the supreme court decided that the substance that novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that novartis did not present evidence of a difference in therapeutic efficacy between the final form of gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts. although the court ruled narrowly, and took care to note that the subject application was filed during a time of transition in indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing, innovation with affordability etc. had novartis won and had its patent issued, it could not have prevented generics companies in india from selling generic gleevec, but it could have obliged them to pay a reasonable royalty under a grandfather clause included in india's patent law. in reaction to the decision, ranjit shahani, vice-chairman and managing director of novartis india ltd was quoted as saying "this ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options." he also said that companies like novartis would invest less money in research in india as a result of the ruling. novartis also emphasised that it continues to be committed to good access to its drugs; according to novartis, by 2013, "95% of patients in india—roughly 16,000 people—receive glivec free of charge... and it has provided more than $1.7 billion worth of glivec to indian patients in its support program since it was started...." sexual discrimination on 17 may 2010, a jury in the united states district court for the southern district of new york awarded $3,367,250 in compensatory damages against novartis, finding that the company had committed sexual discrimination against twelve female sales representatives and entry-level managers since 2002, in matters of pay, promotion, and treatment after learning that the employees were pregnant. two months later the company settled with the remaining plaintiffs for $152.5 million plus attorney fees. marketing violations in september 2008, the us food and drug administration (fda) sent a notice to novartis pharmaceuticals regarding its advertising of focalin xr, an adhd drug, in which the company overstated its efficacy while marketing to the public and medical professionals. in 2005, federal prosecutors opened an investigation into novartis' marketing of several drugs: trileptal, an antiseizure drug; three drugs for heart conditions - diovan (the company's top-selling product), exforge, and tekturna; sandostatin, a drug to treat a growth hormone disorder; and zelnorm, a drug for irritable bowel syndrome. in september 2010, novartis agreed to pay us$422.5 million in criminal and civil claims and to enter into a corporate integrity agreement with the us office of the inspector general. according to the new york times, "federal prosecutors accused novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. but aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that novartis announced in february, the company denied wrongdoing." in the same new york times article, frank lichtenberg, a columbia professor who receives pharmaceutical financing for research on innovation in the industry, said off-label prescribing was encouraged by the american medical association and paid for by insurers, but off-label marketing was clearly illegal. "so it's not surprising that they would settle because they don't have a legal leg to stand on." in april 2013, federal prosecutors filed two lawsuits against novartis under the false claims act for off-label marketing and kickbacks; in both suits, prosecutors are seeking treble damages. the first suit "accused novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug myfortic in exchange for kickbacks disguised as rebates and discounts". in the second, the justice department joined a qui tam, or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: lotrel and valturna (both hypertension drugs), and the diabetes drug, starlix. twenty-seven states, the district of columbia and chicago and new york also joined. avastin outside the us, novartis markets the drug ranibizumab (trade name lucentis), which is a monoclonal antibody fragment derived from the same parent mouse antibody as bevacizumab (avastin). both avastin and lucentis were created by genentech which is owned by roche; roche markets avastin worldwide, and also markets lucentis in the us. lucentis has been approved worldwide as a treatment for wet macular degeneration and other retinal disorders; avastin is used to treat certain cancers. because the price of lucentis is much higher than avastin, many ophthalmologists began having compounding pharmacies formulate avastin for administration to the eye and began treating their patients with avastin. in 2011, four trusts of the national health service in the uk issued policies approving use and payment for administering avastin for macular degeneration, in order to save money, even though avastin had not been approved for that indication. in april 2012, after failing to persuade the trusts that it was uncertain whether avastin was as safe and effective as lucentis, and in order to retain the market for lucentis, novartis announced it would sue the trusts. however, in july novartis offered significant discounts (kept confidential) to the trusts, and the trusts agreed to change their policy, and in november, novartis dropped the litigation. valsartan in the summer of 2013, two japanese universities retracted several publications of clinical trials that purported to show that valsartan (branded as diovan) had cardiovascular benefits, when it was found that statistical analysis had been manipulated, and