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Going, going, gone By Kathy Method, Clinical Senior Editor, Centralized Content Group
Patents set to expire soon on many brand-name drugs
Time is running out on the U.S. patents for many of the most popular brand-name drugs. Unless original exclusivity dates are somehow extended, over the next several years generic versions of many well-known best-selling drugs will become available.
Pharmacists will need to stay abreast of these changes as consumers struggling to cope with the high cost of prescription medications turn to them with the question "Is there a generic for that?" Increasingly, over the next several years, the answer will be yes.
Off patent in 2009 and 2010
Patents have already expired or are soon to expire in 2009 for several brand-name
drugs. From GlaxoSmithKline (GSK), the blockbuster Valtrex
hydrochloride) for the treatment of genital herpes and cold sores goes off patent this
year. Teva has received tentative approval from the Food and Drug Administration (FDA) to begin
marketing its generic version in December.1 Also going off patent is Mepron
antiprotozoal used for the treatment of pneumonia in patients with compromised immune systems.
Mepron is also used to treat Lyme disease.
(lansoprazole), Takeda's blockbuster heartburn and acid reflux medication, will see its patent
expire in 2009 and will be marketed in an over-the-counter version by Novartis, which has acquired the
Three big-name drugs for the treatment of migraine — Ortho-McNeill's Topamax
(dihydroergotamine); and GSK's Imitrex
(sumatriptan) — are going off patent this
year. A generic version of Topamax already has been approved by FDA.3 GSK is evaluating in trials a
spinoff Imitrex-plus-naproxen combination drug, Trexima, which it hopes to launch to replace lost
Generic formulations of Lamictal
(lamotrigine), GSK's treatment for bipolar disorder and epilepsy,
which has lost its patent protection, have been approved by FDA. GSK obtained FDA approval in June,
however, to market its Lamictal XR
(extended release) epilepsy drug, again in the hope of replacing
sales expected to be lost to the generic.6
Patents for many blockbuster brand-name drugs begin expiring at a rapid pace in 2010 and will continue for the next few years. Facing increased competition from generics, drug companies are busy developing
new pipeline drugs and devising strategies to try to hold onto sales for their drugs facing patent expiration.
(atorvastatin) — Pfizer's blockbuster cholesterol pill goes off patent in March 2010. Lipitor is the
best-selling drug in the world, with nearly $13 billion in sales.7 Pfizer has struck a deal with Ranbaxy
Laboratories that will enable release of the generic form outside the United States before patents run out,
but delays U.S. release until November 2011.8
(anastrozole) — AstraZeneca's after-surgery treatment for postmenopausal women with early
breast cancer was set to expire in December 2009, but an extension was granted so that pediatric studies
could be made. It now looks as if June 2010 is the earliest a generic version could become available.9
(donepezil) — Pfizer/Eisai is to lose patent protection in 2010 on this treatment for symptoms
of early Alzheimer's. Teva has gained tentative FDA approval to market its generic version; however,
Eisai and Teva are locked in a patent challenge, keeping the generic off the market for now.10
(losartan) — In April 2010, Merck loses U.S. market exclusivity for Cozaar, its widely prescribed
best-selling treatment for high blood pressure and diabetes. Cozaar is expected to earn at least $3.4
billion in 2009, but generic competition from Teva is likely to quickly chip away at these revenues.11
(levofloxacin) — The patent for Johnson & Johnson's broad-spectrum antibiotic Levaquin was
due to expire in December 2010, but a pediatric study extended the expiration date to June 2011. The
drug ultimately won approval for use in children exposed to anthrax.12
(tamsulosin) — Boehringer Ingelheim/Astella's popular prescription for the treatment of
complications of an enlarged prostate was originally scheduled to go off patent in 2009, but delays will
make a generic version unavailable until March 2010. Ranbaxy acquired exclusive rights to sell the
generic, still under the brand name Flomax, for two months before the patent officially expires.13
Also set to expire in 2010 are Wyeth's blockbuster heartburn medicine, Protonix
cancer drug Hycamtin
(topotecan); Bayer's Climara
(estradiol) hormone-replacement therapy;
(saquinavir), used with ritonavir to treat HIV infection; and UCB's Keppra
(levetiracetam) for the treatment of epilepsy.
2011 and beyond
(fluticasone/salmeterol) — GSK lost some patent protection on its best-selling asthma drug
Advair (also known as Seretide
), in 2009, but additional indications make it more likely for generic
versions to be released in 2011.
(clopidogrel) — Bristol-Myers/Sanofi-Aventis' blockbuster blood-thinning agent for patients with
MI, stroke, and PAD goes off patent in 2011. Sales of Plavix were nearly $5 billion in 2008.14 After much
legal wrangling, Apotex should begin marketing the generic version by the end of the year.15
Several best-selling antipsychotic and antidepressant drugs are expected to go off patent this year, among
them AstraZeneca's second-largest seller, Seroquel
(quetiapine), the 16th-best-selling drug and an
antipsychotic used to treat schizophrenia; Zyprexa
(olanzapine; Eli Lilly), the eighth-best-selling drug,
also used to treat schizophrenia; and the antidepressant Effexor XR
(venlafaxine). Wyeth's best-selling
drug for treatment of depression and panic disorder, Effexor is the subject of a legal struggle between
Wyeth and Teva. Teva can begin selling its generic formulation in 2010.16
Bristol-Myers/Sanofi-Aventis will lose exclusivity for Aprovel
(irbesartan), an angiotensin II receptor
antagonist for treatment of hypertension, in 2011. Pfizer will lose the glaucoma drug Xalatan
(latanoprost ophthalmic solution).
In addition, patents are scheduled to expire in 2011 for Astelin
(azelastine, Wallace) antihistamine nasal
(nafarelin, Roche) nasal spray for precocious puberty and endometriosis; Actos
(pioglitazone, Takeda) for type 2 diabetes; the fertility drug Follistim
(follitropin beta, Organon); and Viramune
(nevirapine, Boehringer Ingleheim), an anti-HIV drug.
Among drugs scheduled to come off patent in 2012 is AstraZeneca's cholesterol-lowering drug Crestor
(rosuvastatin). The company also loses its patent on the asthma drug Symbicort
(budesonide/formoterol) the same year.
Merck loses its top-selling asthma drug, Singulair
(montelukast), as well as its migraine medication, Maxalt
(rizatriptan), in 2012. Merck is working at developing a new migraine medication, but is having
difficulty bringing it to market.17
GSK's patent on the diabetes drug Avandia
(rosiglitazone) expires in 2012; Novartis' Zometa
(zoledronic acid) bisphosphonate cancer drug and its Diovan
(valsartan) antihypertensive both expire in
2012; and Forest Laboratories loses its patent on the antidepressant Lexapro
, also known as Cipralex
(escitalopram), in 2012.
Also in 2012, first patent protection disappears for Pfizer's Viagra
1. Teva Pharm announces tentative approval of generic Valtrex.
October 5, 2007.
Novartis receives approval from FDA to market Prevacid. World Pharma News.
May 18, 2009.
3. US Federal Food and Drug Administration. FDA approves generic Topamax to prevent seizures [FDA press release]. April 1, 2009.
4. Smith A. Glaxo's new drug may save migraine sales. CNNMoney.com. October 12, 2005.
5. Trexima (sumatriptan/naproxen sodium) demonstrated migraine-free response across multiple attacks. Medical News Today.
June 9, 2007.
6. Update 1 — GlaxoSmithKline gets US Lamictal XR approval. Reuters. June 1, 2009.
7. Flooded generic pipeline looms as branded patents expire. Drug Store News
. August 18, 2008.
8. Pfizer and Ranbaxy settle Lipitor patent litigation worldwide. Medical News Today
. June 23, 2008.
9. AstraZeneca receives six months pediatric exclusivity patent extension for Arimidex (anastrozole) from the FDA. PRNewswire. November 29, 2007.
10. Barkhoff AF. Eisai wins preliminary injunction against Teva's generic Aricept. Orange Book Blog.
11. 2-in-1: Merck and Schering-Plough. Will the combination pill create a true industry leader? www.Pharmafocus.com. April 8, 2009.
12. Levaquin approved for pediatric anthrax exposure. FDANews
. May 14, 2008.
13. Astellas and Boehringer Ingelheim reach settlement agreement with Ranbaxy on Flomax patent case. PRNewswire. November 8, 2007.
14. Strong Plavix sales push Bristol-Myers into the black for 'Q4. Cardiovascular Business
. February 4, 2009.
15. Sanofi-Aventis and Bristol-Myers Squibb prevail before the US. Court of Appeals for the Federal Circuit in the US Plavix patent infringement case [press release]. December 12, 2008.
16. Wigginton C. Wyeth's battle for Effexor continues. Law.com. September 19, 2006.
17. Rockoff JD. Merck suffers blow developing new migraine drug. Wall Street Journal
. April 21, 2009.
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