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T o p T w e n T y pay- f o r - D e l ay D r u g s :
H o w D r u g I n D u s t r y Pay o f f s D e l ay g e n e r I c s ,
I n f l at e P r I c e s a n D H u r t c o n s u m e r s
Too often, consumers are forced to shoulder a heavy financial burden, or even go without needed
medicine, due to the high cost of brand-name drugs. Our research indicates that one significant cause is the practice called “pay for delay,” which inflates the drug prices paid by tens of millions of Americans. In a pay-for-delay deal, a brand-name drug company pays off a would-be competitor to delay it from selling a generic version of the drug. Without any competition, the brand-name company can continue demanding This list of 20 drugs known to be impacted by pay-for-delay deals represents the tip of the iceberg. Annual reports by the Federal Trade Commission (FTC) indicate that generic versions of as many as 142 brand-name drugs have been delayed by pay-for-delay arrangements between drug manufacturers since 2005.1 However, because the details of these deals rarely become public, consumers have largely been kept in the dark about the extent of the problem. Information about these twenty specific drugs affected by pay-for-delay deals has been made public thanks to legal challenges brought by the FTC, consumer class action lawsuits, research by legal experts, and public disclosures by drug makers. Key findings of our analysis of these 20 drugs impacted by pay-for-delay deals:
ranging from cancer and heart disease, to drugs for five years, on average, and as $98 billion in total sales of these drugs while the generic versions were delayed.
This report is published by U.S. PIRG and Community Catalyst. July 2013.
U.S. PIRG—When consumers are cheated or the voices of Community Catalyst is a national, non-profit consumer advocacy
ordinary citizens are drowned out by special interest lobbyists, organization that works in partnership with national, state and U.S. PIRG speaks up and takes action. We uncover threats local organizations, policymakers, and philanthropic foundations to public health and well being and fight to end them, using to ensure consumer interests are represented in communities, the time-tested tools of investigative research, media exposés, courtrooms, statehouses and on Capitol Hill. Our Prescription grassroots organizing, advocacy and litigation. Our mission is Access Litigation project has built a coalition of 130 consumer, senior to deliver persistent, result-oriented public interest activism and labor organizations that challenge drug industry practices that that protects consumers, encourages a fair, sustainable block consumer access to affordable medicines, including the pay- economy, and fosters responsive, democratic government. for-delay deals concerning Provigil, Cipro, K-Dur, and Tamoxifen. More information at www.communitycatalyst.org.
Impact of pay for Delay on consumers
While the specifics of pay for delay are only now beginning to be understood by the public, the consequences of this price-inflating practice are all too real for consumers and taxpayers. The drug Provigil, prescribed for sleep disorders and multiple sclerosis-related fatigue, offers a case study: Experts expected a generic version of Provigil to go on the market in late 2005, but brand-name manufacturer Cephalon paid more than $200 million to four different generic drug manufacturers, who kept their generics off the market until 2012.2 In the meantime, many patients had to pay up to $1,200 each month for the drug, or manage without it. In 2010, the FTC estimated that a pay-for-delay deal for a single drug could cost an individual consumer and their health plan an extra $4,590 over 17 months.3 Extended over the average five-year length of a pay-for-delay deal, that amounts to $16,200 in wasteful spending per patient, per drug, This not only forces consumers to pay higher premiums and out-of-pocket costs, it also means that taxpayers foot higher drug bills in Medicare and other programs. The FTC estimated in 2010 that these deals cost consumers and taxpayers $3.5 billion each year in higher drug costs.4 But for drug companies, pay-for-delay deals can translate to a windfall in higher profits. As the CEO of Cephalon, the drug company that makes Provigil, reportedly said about the deal that kept generic Provigil off the market, “That’s $4 billion in sales that no one expected.”5 methoDology:
Our list of the Top Twenty Pay-for-Delay Drugs details 20 drugs impacted by one or more known pay-for-delay deals which include a payment by the brand-name drug company in exchange for an agreement by the generic drug maker to delay bringing a generic to market. As described above and detailed in the endnotes, informa- tion about these 20 specific drugs affected by pay-for-delay deals has been made public thanks to legal chal- lenges brought by the FTC, consumer class action lawsuits, research by legal experts, and public disclosures by When computing the average difference between brand-name and generic drugs, we included only those drugs for which there was both a brand-name and generic price available. We did not include the estimated prices for the five generic drugs that are currently delayed.
To estimate the combined total sales of these 20 brand-name drugs while the generic versions were delayed, we conservatively assumed a 10% annual growth rate in drug sales revenue for brand-name drugs before the generic entered the market. Starting from the most recent available sales revenue before generic entry, we then estimated sales for the previous years. For instance, with annual sales for Adderall XR at $1.5 billion the year before generic entry, sales for the two previous years were estimated to be $1.364 billion and $1.239 billion, for a total of $4.103 billion. We did not project sales revenue forward for drugs currently protected by pay- Top 20 Generics DelayeD by pay-for-Delay Deals
prescription Drug
condition the
annual sales
length of
price of brand-name Drugc
(and Drug Maker)
Drug is commonly
before Generic
pay-for-
prescribed to Treat
($ millions)
Delay Deal
price of Generic Drug ($)
adderall Xr
YED aggrenox
DELA (Boehringer Ingelheim) Stroke risk, blood clots
UNTIL 2015
androGel
maceuticals/ Low testosterone in patients with DELA Abbott Laboratories)
UNTIL 2015
effexor Xr
lamictal
YED nexium
DELA (AstraZeneca)
UNTIL 2014
YED niaspan
DELA (Abbott Laboratories)
YED nuvigil
DELA (Cephalon/Teva)
UNTIL 2016
nolvadex/Tamoxifen
propecia
provigil
sinemet cr
Wellbutrin Xl -150 mg
A Annual Sales are U.S. sales as reported at www.Drugs.com for the last full year C Unless otherwise indicated, drug prices are as available at 14 CVS locations in before generic entry, unless otherwise indicated.
Boston, MA, for the default dosage and quantity, as advertised at www.GoodRx.
com on 6/10/2013 or 6/13/2013. These drug prices are typical of those available B Unless otherwise indicated, the time between settlement and generic entry was calculated conservatively, rounding up the month of known settlements, and rounding down the month of generic entry. This length of time is assumed to be a † For drugs not yet available as generics, prices are conservatively estimated to be 25 reasonable proxy for the length of delay caused by pay-for-delay settlements. ENDNOTES:
1 Based on data compiled from annual Pharmaceutical Agreement Filings, FY2005-FY2012, schering.shtm; See also Hemphill, supra note 6 (reporting a settlement including payment posted on the FTC website at http://www.ftc.gov/bc/healthcare/drug/index.htm. and an agreed delay of generic entry for 4 years). 2 FTC. V. Cephalon, Complaint, Feb. 13, 2008, at 3, available at http://www.ftc.gov/os/ 22 The cost of brand-name K-Dur was not available at website listing prices and availability at caselist/0610182/080213complaint.pdf (noting that “Cephalon bought off all four of its 70,000 pharmacies nationwide. See www.GoodRx.com.
potential competitors” by “paying more than $200 million collectively” in exchange for their agreement to delay generic “entry until April 2012.”) 23 Hemphill, supra note 6 (reporting a settlement in 2005 that included payment and an agreed delay of generic entry for 3 years). 3 Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions, An FTC Staff Study, Jan. 2010, at page 4, available at http://www.ftc.gov/ 24 Delayed consumer access to a generic of Lipitor occurred from April 2010 to Nov. 2011, inclusive, amounting to a delay of 20 months, or 1.7 years, based on the expiration of the Pfizer patent on Lipitor’s active ingredient on approximately March 24, 2010 (see Patricia Hurtado, Pfizer, Ranbaxy Sued Over Alleged Anti-Competitive Scheme, Bloomberg News, February 09, 2012, available at http://www.businessweek.
5 Cephalon CEO Frank Baldino as quoted on the Provigil pay for delay deals in the com/news/2012-02-09/pfizer-ranbaxy-sued-over-alleged-anti-competitive-scheme.
Philadelphia Business Journal, Hurdles ahead for Cephalon, Mar 20, 2006, available at html) and the generic entry on Nov. 30, 2011. Pfizer’s settlement on June 18, 2008 http://www.bizjournals.com/philadelphia/stories/2006/03/20/story1.html.
with Ranbaxy included a delay of generic launch until Nov 30, 2011. See Pfizer 6 Scott Hemphill, An Aggregate Approach to Antitrust Using New Data and Rulemaking to and Ranbaxy settle Lipitor patent litigation worldwide, Press Release, June 18, 2008, Preserve Drug Competition, Columbia Law Review, Jan. 2009, at 11, Table 2: Settlements available at http://www.pfizer.be/sites/be/nl/media/press_bulletins/in_general/Pages/ with Monetary Payment (reporting a settlement in 2006 that included payment and PfizerandRanbaxysettleLipitorpatentlitigationworldwide.aspx. an agreed delay of generic entry for 3 years). However, because the first two generics 25 2012 U.S. sales, at http://www.drugs.com/stats/top100/2012/sales.
introduced by Teva and Impax Labs were ‘authorized generics’ allowed under an exclusive licensing agreements provided in Teva’s pay-for-delay settlement, the delay of true generic 26 Estimated delay of 6.1 years based upon a pay-for-delay agreement on or about April competition and resulting lower prices was probably 5.8 years, until approx. June 2012. 14, 2008, which delayed generic access from May 2008 to anticipated generic launch See Tracy Staton, FDA hits Shire with early nod for Adderall XR copycat, FiercePharma, on May 27, 2014, inclusive. See In re Nexium (Esomeprazole) Antitrust Litigation, No. June 25, 2012, available at http://www.fiercepharma.com/story/fda-hits-shire-early-nod- 12-md-02409-WGY (D. Mass.) Document # 95, filed Jan. 22, 2013, at page 27, available adderall-xr-copycat/2012-06-25. (noting FDA’s approval of a third generic of Adderall at http://www.wexlerwallace.com/wp-content/uploads/2013/03/In-Re-Nexium- XR “ushers onto the market a lower-priced rival” to the first two generics). Esomeprazole-Ant.pdf; See also Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of generic entry for 6 years).
7 2012 U.S. sales not publicly available; 2011 U.S. sales at https://host1.medcohealth.com/ art/corporate/anticipatedfirsttime_generics.pdf.
27 2012 U.S. Sales, at http://www.drugs.com/stats/top100/2012/sales.
8 Adam Greene, Analyzing Litigation Success Rates, RBC Capital Markets Industry Comment, 28 Greene, supra note 8 (reporting a settlement in April 2005 with anticipated generic launch Jan. 15, 2010, at http://amlawdaily.typepad.com/pharmareport.pdf, at Appendix in September 2013); Hemphill, supra note 6 (reporting a settlement including payment and C (reporting a settlement in Aug. 2008 and anticipated generic launch in July, 2015, an agreed delay of generic entry for 8 years). Generic entry was delayed from at least resulting in a delay from Sept. 2008 to June 2015); and Hemphill, supra note 6 (reporting May 2005 to August 2013, amounting to 100 months, or 8.3 years. a settlement including payment and an agreed delay of generic entry for 7 years). 29 2011 U.S. Sales from Medco/Express Scripts, at https://host1.medcohealth.com/art/ 9 2009 U.S. sales data not publicly available; listed data are for “the calendar year of corporate/anticipatedfirsttime_generics.pdf.
settlement [2006] or the twelve months preceding settlement, or where unavailable, the closest available year” from Hemphill, supra note 6.
30 Teva settles Nuvigil litigation with Mylan, April 30, 2012, Bloomberg, available at http:// www.bloomberg.com/apps/news?pid=newsarchive&sid=acXTuf7zOK34 (reporting April 10 Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of 2012 settlement including delayed entry until June 2016 in exchange for exclusive licensing 11 2012 U.S. sales, at http://www.drugs.com/stats/top100/2012/sales. 31 2001 U.S. sales data are not publicly available; listed data are for 1993 “the calendar year of settlement or the twelve months preceding settlement, or where unavailable, the 12 FTC v. Watson Pharma, 09-cv-00955 (N.D. GA), Second Amended Complaint, May 28, closest available year” from Hemphill, supra note6.
2009, at para. 65 (disclosing that pay-for-delay agreements on September 13, 2006 included an agreed delay of generic entry until August 31, 2015) available at http:// 32 Hemphill, supra note 6 (reporting a settlement in 1993 that included a payment and an www.ftc.gov/os/caselist/0710060/090528androgelfinalcmpt.pdf. Thus pay-for-delay agreed delay of generic entry for 9 years).
settlements delayed generic Androgel from at least Jan. 2007 to Aug. 2015, amounting to 33 Nolvadex price is calculated as 50% of the price of $197.23 for 60 tablets, as reported in Bennish et. al v. Barr Labs, 00-cv-74948 (E.D. MI) Doc #1, Complaint, Nov. 9, 2000, at 13 2000 U.S. Sales, at http://www.ftc.gov/os/2003/03/bristolmyerscmp.pdf, para. 4.
para. 62, available through PACER.gov (citing a www.drugs.com price on Oct. 4, 2000). 14 FTC enforcement action (In the Matter of Bristol-Myers Squibb Company, Docket No. 34 2012 U.S. Sales not publicly available. 2011 U.S. Sales from Medco/Express Scripts, at C-4076, at http://www.ftc.gov/os/2003/03/bristolmyerscmp.pdf) reports a settlement https://host1.medcohealth.com/art/corporate/anticipatedfirsttime_generics.pdf.
on December 2, 1994, and generic entry in “late March 2001.” This equals a delay from approximately Jan. 1995 to March 2001 inclusive, equaling 75 months, or 6.25 years; See 35 Hemphill, supra note 6 (reporting a settlement in 2006 that included payment and an also Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay agreed delay of generic entry for 7 years).
36 2011 U.S. Sales, at http://www.drugs.com/stats/top100/2011/sales, citing IMS Health.
15 The cost of brand-name Buspar is not available at website www.GoodRx.com, which lists 37 Multiple pay-for-delay settlements starting in December 2005 allowed for generic entry prices and availability at 70,000 pharmacies nationwide. in April 2012, causing a delay in generic access from Jan. 2006 to at least March 2012, 16 Caduet has the same active ingredient as Lipitor, and is subject to the same patents. See inclusive, amounting to 75 months, or 6.25 years. Greene, supra note 8, at Appendix C; Lipitor, note 24, below, and Greene, supra note 8, at Appendix A; See also Hemphill, See also Hemphill, supra note 6 (reporting a 2006 settlement that included payment and an supra note 6 (reporting a settlement including payment and an agreed delay of generic agreed delay of generic entry for 6 years).
38 2006 U.S. sales data not publicly available. Presented are for 1995 “Annual U.S. sales, 17 1996 U.S. sales, see Bayer Settles Cipro Patent Squabble, ICIS Chemical Business, Jan. 27, in millions of dollars, measured in the calendar year of settlement or the twelve months 1997, available at http://www.icis.com/Articles/1997/01/27/6512/bayer+settles+cipro preceding settlement, or where unavailable, the closest available year. “ as reported in 18 Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay 39 Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of of generic entry for 7 years); In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323, 1130 (Fed. Cir. 2008)(noting at footnotes 7, 8 that multiple settlements 40 Reported amounts are half of the 2006 U.S. sales for both for both 150mg and 300 mg on approximately Jan. 27, 1997 included payments totaling $398 Million, and doses of Wellbutrin XL were $1,670,516 at http://www.drugs.com/top200_2006.html. agreements to delay generic until entry until Jan. 2004) available at http://www.ftc.gov/ This is a conservative estimate, because the 150mg dose is more commonly prescribed than os/2010/04/100429ciprostatement.pdf.
19 Greene, supra note 8, at Appendix C (reporting a settlement in Oct. 2005 and anticipated 41 Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of generic launch in July 2010, amounting to 56 months, or 4.7 years); See also Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of generic 42 1997 U.S. Sales data are not publicly available. Reported data are for 1995 “Annual U.S. sales, in millions of dollars, measured in the calendar year of settlement or the twelve 20 2000 U.S. sales data not publicly available; listed data are for “the calendar year of months preceding settlement, or where unavailable, the closest available year” as reported settlement [1997] or the twelve months preceding settlement, or where unavailable, the closest available year” from Hemphill, supra note 6.
43 Hemphill, supra note 6 (reporting a settlement including payment and an agreed delay of 21 An FTC enforcement action reported pay-for-delay settlements in June 1997 delayed generic access until Sept 2001, resulting in a delay from at least July 1997 to at least Aug. 2001, amounting to 48 months, or 4 years. See http://www.ftc.gov/opa/2001/04/

Source: http://www.uspirg.org/sites/pirg/files/reports/Top_Twenty_Pay_For_Delay_Drugs_USPIRG.pdf