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2014 Update - First Time Brand-to-Generic Switches

Micardis, Micardis HCT by Boehringer Ingelheim

In January 2014, FDA approved Actavis' telmisartan immediate-release tablets, 20 milligram (mg), 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's (BI) Micardis. Micardis is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure, and to reduce cardiovascular risk in patients older than 55 years of age unable to take ACE inhibitors. A combined generic telmisartan-hydrochlorothiazide (Micardis HCT), which also contains a diuretic, received FDA approval in Feb 2014. According to Fierce Pharma, BI global sales of Micardis/Micardis HCT exceeded $2.2 billion in 2013.

Rapamune by Pfizer

Rapamune (sirolimus) is a selective immunosuppressant drug used to prevent kidney transplant rejections. On January 7, 2014, the patent expired for Rapamune, and the FDA approved the generic 0.5 mg tablet version of sirolimus; the 1 mg strength has also received tentative approval. Zydus received the 180-day marketing exclusivity on sirolimus preventing sales by other generic manufacturers for 6 months.

Pfizer’s Rapamune garnered sales of $203 million in 2013, according to IMS data. The patent on the oral solution form of sirolimus also expires in 2014.

Loestrin 24 Fe by Warner Chilcott (Actavis)

Warner Chilcott's Loestrin 24 Fe is an oral contraceptive agent FDA-approved in 2006. Loestrin 24 Fe combines the estrogen ethinyl estradiol with the progestin norethindrone. Warner Chilcott was acquired by Actavis in October 2013. Actavis Pharma has discontinued Loestrin 24 Fe, but replaced it with an equivalent product called Minastrin 24 Fe. In addition, Amneal's generic equivalent became available the first week of January 2014 under the name of Lomedia 24 Fe. According to IMS market data, annual Loestrin 24 Fe U.S. sales were over $510 million in June 2013. Most women can now get birth control free through their health insurance, thanks to Obamacare.

Asacol by Warner Chilcott (Actavis)

Asacol (mesalamine) is used in the treatment of Crohn’s disease or ulcerative colitis and its patent was set to expire in January 2014. However, according to FDA, no generic versions of the delayed-release mesalamine 400 mg are available. Instead, many brand (and higher-priced) versions exist in slightly different forms. Why is this? In June 2014, Asacol 400 mg delayed-release tablets were discontinued by the manufacturer, who then introduced an equivalent (but newly patented) product - Delzicol. One possible objective - to delay competition from a more affordable generic mesalamine. Zydus is expected begin marketing generic Asacol HD in 2015-2016.

Avelox by Bayer HealthCare

Generics for the oral antibiotic Avelox (moxifloxacin) became available in the first quarter of 2014. Currently, four approvals for lower-cost versions of Avelox are noted by the FDA, including those by generic drug makers Teva, Dr. Reddy’s, Torrent, and Aurobindo. Moxifloxacin, a fluorquinolone, is used to treat different types of bacterial infections of the skin, sinuses, lungs (pneumonia, bronchitis), or stomach. In addition, the 0.5% ophthalmic solution of moxifloxacin (Vigamox, Moxeza) has been tentatively approved by the FDA, but brand patent loss is not expected until 2019 or 2020. Ophthalmic moxifloxacin is indicated for treatment of conjunctivitis (pink eye).

Evista by Eli Lilly

Evista (raloxifene) by Eli Lilly lost patent protection in March 2014. Raloxifene is approved to treat or prevent osteoporosis in postmenopausal women. Raloxifene is also used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are otherwise at risk of breast cancer. Teva will start shipping raloxifene by the end of March. Evista remained a top 100 drug in years 2011-2013 and had over $800 million in U.S. sales in 2013 alone.

The U.S. Preventive Task Force now recommends that doctors offer tamoxifen or raloxifene to high-risk patients as a breast cancer preventive.

Nexium by AstraZeneca

AstraZeneca's Nexium (esomeprazole), popularized as the "purple pill", may be the most well-known brand name drug turning generic in 2014. The heartburn and ulcer treatment blockbuster will lose its patent in May 2014. Nexium reaped over $6 billion in 2013 and has been long ranked as a top 5 drug by sales. Nexium will not only go generic in 2014, but an over-the-counter (OTC) version of the product, Nexium 24HR is now approved. However, Nexium 24HR may have an uphill battle if not priced right; the U.S. market is already well-saturated with OTC proton pump inhibitors. In 2013, Hanmi launched esomeprazole stronium; this product is not AB-rated and is not automatically substitutable for Nexium.

Lunesta by Sunovion

If you watch TV, you have probably seen Sunovion's Luna Moth slowly flutter across your screen. The brand, Lunesta (eszopiclone) is an oral insomnia agent and the last of the "Z" drugs to go generic, in 2Q 2014. Low cost generic competitors include zaleplon (Sonata) and zolpidem (Ambien). The Lunesta brand brought in over $825 million in 2013. These nonbenzodiazepine medications cause relaxation to help you fall asleep and stay asleep. But these drugs have some serious side effects too - unusual sleep-related behaviors, like sleep-driving, sleep-eating, and even sleep-sex, have occurred - and the patient has no memory of the event (retrograde amnesia) come morning.

Celebrex by Pfizer

Celebrex (celecoxib) is a well-known and widely prescribed COX-2 inhibitor NSAID used for pain and arthritis. The FDA approved the first version of generic Celebrex in May 2014. Teva Pharmaceuticals gained the 180-day exclusivity rights, and will market the 100 mg, 200 mg, and 400 mg strengths, and may launch their generic celecoxib as early as Dec. 2014. Mylan also has marketing rights for the 50 mg capsule.

Several companies are anxious to market the generic Celebrex - and understandably so - in 2013 Celebrex brought in over $2.9 billion in sales for Pfizer.

Actonel by Warner Chilcott (Actavis)

Warner Chilcott, acquired by Actavis in October 2013, is losing several brands in 2014. Their osteoporosis brand Actonel (risedronate) became available generically in June. Actonel is a bisphosphonate that alters the cycle of bone formation and breakdown in the body to help increase bone mass and prevent bone fractures. Risedronate is also used to treat Paget's disease of the bone.

According to FDA, several generic manufacturers are lined up to start marketing risedronate in June - including Teva, Apotex, and Mylan. Actonel brought in over $500 million in sales for Warner Chilcott in 2012.

Xeloda by Hoffman La Roche/Genentech

Xeloda (capecitabine) is an oral medication used to treat advanced breast or colorectal cancer that has spread to other parts of the body. In September of 2013 the FDA approved generic versions of Xeloda made by Teva in the 150 mg and 500 mg strengths. Generic versions of Xeloda became available in March 2014.

Xeloda is widely used by patients with cancer, but a 30 tablet supply of Xeloda can cost over $1000, so generic options can save hundreds of dollars. Insurance may pay for a large portion of the drug. Genentech may be able to offer copay assistance on the brand, as well, if the patient prefers.

Nasonex by Merck

Nasonex is a drug with a puzzling patent status. Nasonex (mometasone furoate monohydrate) is a nasal corticosteroid used to treat and prevent symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. The Nasonex patent was set to expire in July 2014, but a court ruling has extended that date through 2017. To confuse matters, Apotex has a mometasone formulation up for FDA approval that will not compete with the Nasonex patent. Plus, Sanofi's OTC Nasacort (triamcinolone) made its debut in 2013. In 2011-2013, the Nasonex brand brought in over $3.1 billion in U.S. sales for Merck.

Exforge/Exforge HCT by Novartis

Exforge is a single-tablet combination of an angiotensin receptor blocker (ARB) (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension; Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) adds a diuretic. These agents were the first to combine a calcium channel blocker and ARB into one tablet. The Novartis patent for Exforge and Exforge HCT is approaching its expiration in October 2014; in fact, several generic equivalents are already approved by the FDA. However the exact launch dates of the generics are not known. U.S. sales for Exforge products have been low as of late - hovering just around $350 million in 2012.

Copaxone by Teva Pharmaceuticals

Leading generic manufacturer Teva Pharmaceutical also has a leading brand product - Copaxone (glatiramir injection) - a major blockbuster for multiple sclerosis (MS) treatment. Copaxone may be available generically from Momenta, Sandoz and Mylan as early as May 2014. Copaxone brought in over $3.6 billion in revenue in 2013. But things are quickly changing in the MS market - oral agent Tecfidera (dimethyl fumarate) is now approved, and is expected to be the next MS blockbuster for Biogen Idec. Analysts expect Copaxone sales to decline over 50 percent by 2016. Teva is trying to quickly move patients over to the new 3 times per week Copaxone formulation, approved in January.

TOBI Nebulizer Solution by Novartis

TOBI (tobramycin) nebulized solution is an aminoglycoside antibiotic used to fight lung infections and mucous buildup caused by bacteria in patients with cystic fibrosis. Tobramycin solution is inhaled into the lungs using a nebulizer, which can be cumbersome. The patent on TOBI was due to expire in October 2014, but the generic is already marketed due to agreements with Teva Pharm. In March, 2013 the FDA approved Novartis' TOBI Podhaler, an inhaled powdered solution that is more easily and efficiently administered via a handheld device. The TOBI Podhaler may help to offset the losses due to generic competition from the nebulized solution. Sales of nebulized TOBI in 2011 were $159 million.

Avandamet by GSK

Avandamet was FDA-approved in a generic formulation in May 2014. Avandamet, a combination tablet of metformin and rosiglitazone, is used along with a diet and exercise program to treat type 2 diabetes. In November, 2013, the FDA determined that data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and the sulfonylureas. Therefore, the prescribing and dispensing restrictions put into place in 2010 for rosiglitazone medicines were lifted. Teva has received 180 days of generic drug exclusivity for the generic formulation.

Diovan by Novartis

Valsartan, the generic for Novartis' high blood pressure drug Diovan, was FDA-approved for a commercial launch by Ranbaxy in June 2014. The drug lost patent in 2012, and Ranbaxy has the 180-day exclusivity on the drug, meaning no other generic manufacturer can launch valsartan for that time period. Ranbaxy was late in their launch due to quality issues at most of their manufacturing plants. In addition to high blood pressure, valsartan is also used to treat heart failure and to lower the risk of death after a heart attack. Valsartan is in a class of drugs known as angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Ranbaxy's New Jersey-based Ohm Laboratories will make the 40, 80, 160, and 320 mg doses.

Pennsaid 1.5% by Nuvo/Mallinckrodt

In May, 2014 topical diclofenac sodium solution 1.5% , the generic formulation of Pennsaid, was FDA-approved. According to the FDA, Apotex Pharmaceuticals is currently supplying this generic product. Both Paddock and IGI Labs also have tentative FDA approvals to manufacturer the 1.5% solution. Nuvo/Mallinckrodt received approval for the higher strength Pennsaid 2% in 2014. Topical diclofenac 1.5%, an NSAID, is used to treat pain and swelling associated with knee osteoarthritis and delivers the active drug through the skin directly to the site of inflammation and pain.

Finished: 2014 Update - First Time Brand-to-Generic Switches

Flashback: FDA Drug Approvals 2013

In 2013, the U.S. Food and Drug Administration (FDA) approved 27 New Molecular Entities (NMEs). According to the FDA, an NME contains an active ingredient that has not been previously…



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