Generic Drug Trends: Generics Pipeline Predicts Continued Market Share Gains Through 2014
Original Article by: Dalia Buffery, MA, ABD American Health & Drug Benefits November/ December 2010
The outlook for generics for the next 4 or 5 years continues to shine, judging from patent expiration dates for many of the top-selling drugs. The generics pipeline, therefore, practically ensures that the past several years trend of increasing market share for generics will continue with a vengeance. This does not bode well for brand-name manufacturers, which will each be losing billions in annual sales (Table), but it does foretell greater access to top-rated yet, less expensive medications a positive step overall in the current state of economic morass.
But while the success of nonbiologic generics continues, the future for biogenerics or biosimilars remains in limbo, despite the passing of the Biologic Price Com petition and Innovation Act earlier this year. This first legislation toward the creation of a path for biosimilars still requires much work, as Rasmus Rojkajaer, MD, PhD, Head of Global Biologics Research & Develop ment at Mylan, suggested on behalf of the Generic Pharmaceutical Association to industry attendees at the November 3 public hearing convened by the US Food and Drug Administration. Dr Rojkajaer stressed the need to ensure that patients gain access to more affordable biogeneric and biosimilar products, while at the same time maintaining incentives to innovate new medicines.
As a result, the predictable increased growth in generics market share will continue to consist for the most part of nonspecialty drugs, even while the pharmaceutical research and development efforts are leaning heavily on specialty rather than nonspecialty products.
Of the current 50 top-selling nonspecialty drugs, 25 should become available in a generic formulation within the next 5 years, according to Brian W. Kolling, PharmD, Director, Pipeline and Trend Forecasting, Part D, at Prescription Solutions. Specifically, significant generic activity will occur in 5 key clinical areas: cardiovascular (CV) disease, central nervous system (CNS), diabetes, gastrointestinal (GI), and respiratory conditions. This includes the patent expiration for 2 of the top-selling statins: Lipitor in 2011 and Crestor in 2016, which garnered >$5 billion and >$2 billion, respectively, in 2009 sales, and the top GI drug (Nexium), with >$5 billion (see Table below).
As shown in the Table, of the 29 major nonspecialty drugs to lose patent in the next 5 years, almost half (N = 14) had billions of dollars in sales in 2009, amounting to just under $43 billion ($42.8 billion) combined. Of the 10 top-selling agents worldwide, 3 top CV agents in 3 different classes: a statin (Lipitor), an angiotensin receptor blocker (Diovan), and an antiplatelet (Plavix), will lose patent by 2012, to the tune of $10.94 billion (in 2009) combined in lost revenue to their manufacturers.
In addition, the patent expiration of 8 key CNS drugs—with billions of dollars in 2009 sales, each, for 5 of them (Abilify, Cymbalta, Lexapro, Seroquel, and Zyprexa) further reinforces the potential impact of this trend toward greater access to generic medications on patient management, as well as on overall drug cost reductions for patients and health plans.
Therefore, despite the lack of significant progress on the biosimilars front by the end of 2010, the outlook for nonspecialty generic drug activity remains bright and will continue to lead the rapidly approaching 80% in generic market share as a percentage of total prescriptions written in the United States, and with it the increased access to popular drugs, albeit wrapped in new clothes, as well as considerable cost reductions for patients, health plans, and employers.
| Brand Name (generic) | Manufacturer | Expected Generic Launch | 2099 Annual Sales ($ thousands) |
|---|---|---|---|
| Cardiovascular Diseases | |||
| TriCor (fenofibrate) | Abbott | March 2011-July 2012 | 1,224,894 |
| Lipitor (atorvastatin calcium) | Pfizer | November 2011 | 5,363,193 |
| Avapro (irbesartan) | Bristol-Myers Squibb | March 2012 | 398,768 |
| Plavix (clopidogrel bisulfate) | Bristol-Myers Squibb | May 2012 | 4,223,124 |
| Atacand (candesartan cilexetil) | AstraZeneca | December 2012 | 152,603 |
| Diovan (valsartan and hydrochloro-thiazide, USP) | Novartis | September 2012 | 1,328,515 |
| Niaspan (niacin) | Abbott | September 2013 | 716,589 |
| Crestor (rosuvastatin calcium) | AstraZeneca | July 2016 | 2,308,138 |
| Central Nervous System Conditions | |||
| Zyprexa (olanzapine) | Eli Lilly | July 2014 | 1,855,436 |
| Lexapro (escitalopram oxalate) | Forest | March 2012 | 2,334,422 |
| Seroquel (quetiapine fumarate) | AstraZeneca | March 2012 | 3,117,591 |
| Geodon (ziprasidone hydrochloride) | Pfizer | September 2012 | 873,952 |
| Provigil (modafinil) | Cephalon | April 2012 | 883,339 |
| Abilify (aripiprazole) | Bristol-Myers Squibb | April 2015 | 3,083,351 |
| Lunesta (eszopiclone) | Sepracor | May 2014 | 813,087 |
| Cymbalta (duloxetine hydrochloride) | Eli Lilly | July 2014 | 2,404,353 |
| Diabetes | |||
| Avandia (rosiglitazone maleate) | GlaxoSmithKline | March 2012 | 407,906 |
| Actos (pioglitazone hydrochloride) | Takeda | August 2012 | 2,531,621 |
| Gastrointestinal Conditions | |||
| Aciphex (rabeprazole sodium) | Eisai | May 2013 | 996,052 |
| Nexium (esomeprazole sodium) | AstraZeneca | April 2014 | 5,014,827 |
| Respiratory Conditions | |||
| Clarinex (desloratadine) | Schering/Merck | January 2012 | 181,215 |
| Xopenex nebulizer (levalbuterol) | Sepracor | August 2012 | 356,898 |
| Singulair (montelukast sodium) | Merck | August 2012 | 3,027,378 |
| Advair (fluticasone propionate, salmeterol xinafoate) | GlaxoSmithKline | TBD | 3,653,410 |
| Other Categories | |||
| Xalatan (latanoprost) | Pfizer | March 2011 | 457,121 |
| Levaquin (levofloxacin) | Ortho-McNeil-Janssen | June 2011 | 1,373,131 |
| Uroxatral (alfuzosin hydrochloride) | sanofi-aventis | Jylu 2011 | 174,034 |
| Boniva (ibandronate sodium) | Genentech | March 2012 | 511,277 |
| Actonel (risedronate sodium, calcium carbonate) | Warner Chilcott | June 2014 | 435,977 |