• February 24, 2005. Mark Wainberg in the Journal of the American Medical Association. Generic HIV Drugs — Enlightened Policy for Global Health.
• May 1, 2004. Scott R. Penzak, Edward P. Acosta, Michele Turner, Jorge A. Tavel, and Henry Masur in the Journal of Clinical Infectious Disease. Antiretroviral Drug Content in Products from Developing Countries. Also, see this news story published in The Advocate on this journal aricle: Study says generic anti-HIV drugs meet U.S. standards.

Related CPTech Pages

• Generic Biologics.
• Fixed-Dose Combination Antiretrovirals.
• Patents and Medical Research Use Exemptions (Bolar issues)
• Northern Generic and Southern Domestic Drug Companies.
• The Hatch-Waxman Act.
• World Health Organization Survey of Safe HIV/AIDS Drugs and Manufacturers
• Generic Paclitaxel (Taxol).
• Glucophage

• October 21, 2004. Bill Haddad. Report prepared for the UN Millenium Committee. Generic Medicines: The Solution or the Problem.
• Generic Drug Industry Dynamics. February, 2002. Report prepared by David Reiffen and Michael Ward for the FTC.
• How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry, a July 1998 report by the Congressional Budget Office
• Pharmacy Mark-Ups of generic drugs, from December 31, 1998 story in the Wall Street Journal by ELYSE TANOUYE, "Price Markups on Generics Can Top Brand-Name Drugs."
• Copy=Right - Generics Now. Webpage for the upcoming international summit on access to generic drugs. Includes pricing data for generic and branded drugs in a cross-section of countries.
• Ontario Brand/Generic Price Comparisons for Top 25 Genericized Products(2001). Table prepared by the Canadian Drug Manufacturers Association.

U.S. Patent Extentions

• 35 USC 156, regarding Extentions of Patent terms.
• March 19, 2002. Chris Adams and Gardiner Harris for the Wall Street Journal. Research on Drugs for 'Neglected Diseases' Urged.
• December 10, 2002. David Balto. Summary of Congressman Waxman's November 29 speech on abuses of the Hatch-Waxman Act.
• May 1, 2001. Press release from Senator John McCain. McCain, Schumer Unveil Initiative to Save Consumers $71 Billion on Prescription Drugs. Annouces the introduction of S.812, a bill that would close loopholes in the Hatch Waxman Act that are effectively used by the pharmaceutical industry to delay the market entrance of generic competition. Also, see the Public Citizen press release.
• June 24, 2001. Charles Ornstein for the Dallas Morning News. Law keeps generics in limbo.
• October 11, 2001. FTC Press Release. FTC to Study Generic Drug Competition. Annoucement of a proposed study to be conducted by the FTC: "The proposed study would examine whether the 30-month stay and 180-day marketing exclusivity provisions of the Hatch-Waxman Act have encouraged generic competition or facilitated the use of anticompetitive strategies."
• August 2000. Michie I. Hunt, Linda Kotis and Nancy Chockley. Published by the National Institute for Health Care Management. Prescription Drugs and Intellectual Property Protection. (pdf format)
• July 28, 1999. Stephen W. Schondelmeyer, PRIME Institute, College of Pharmacy, University of Minnesota. Patent Extension of Pipeline Drugs: Impact on U.S. Health Care Expenditures.
• November 16, 1998 article from Time Magazine on Searle & Co, The Mysterious Midnight Favor
• October 9, 1998, Public Citizen Release, Increase Drug Prices for Seniors, on an attempted patent extension for Claritin and Relafen.
• October 1998 Multinational Monitor Editorial An Allergy to Democracy, on an attempted patent extension for Claritin.
• February 27, 1996, Prepared Statement of Michael Kantor, United States Trade Representative, Before the Senate Judiciary Committee. This testimony concerns patent extentions given as an error in GATT legislation.
• October 24, 1995, James Love, Letter to Senator Dole on Chaffee/Pryor generic drug amendment, concerning patent extentions.

Lawsuits Relating to the "Evergreening" of Patents

• July 12, 2001. Gardiner Harris and Chris Adams. Drug Manufacturers Are Intensifying Courtroom Attacks That Slow Generics.
• June 9, 2001. Denise Gellene for the LA Times. Drug Makers: New Targets of Class-Action Lawsuits.
• June 8, 2001. Reuters. Novartis unit challenges Glaxo antibiotic patent.
• June 7, 2001. Reuters. Lawsuit over Schering conspiracy to block generic K-Dur20.

• CPT page on Data Exclusivity (heath registration data). On this topic, see in particular:
• CPT Testimony on Health Registration Data Exclusivity, Biomedical Research, and Restrictions on the Introduction of Generic Drugs. Hearings in the U.S. Senate, Committee on Appropriations, Subcommittee on Labor, Health and Human Services and Education and Related Agencies. The hearings focus on a proposal to extend US health registration protection from 5 to 10 years, in exchange for R&D royalty of 3 percent paid to NIH and 3 percent R&D reinvestment requirement. The proposal, which is pushed by Bristol-Myers Squibb to protect Taxol, is rejected.

FDA Documents

• May 10, 2001. Bernard Schwetz, Acting Principal Deputy Commissioner of the FDA. Testimony before United States Senate Committee on Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies. Includes this passage:

  "Generic drugs substantially reduce the cost of purchasing pharmaceuticals by typically offering price discounts from 50% to 75%."

• 1999. FDA's Center for Drug Evaluation adn Research report to the Nation. Improving Public Health Through Human Drugs.

  "The biggest difference between a generic drug and its brand name counterpart is usually price. A generic drug may be priced anywhere between 20 percent and 75 percent of the cost of the brand name version."

• July 6, 2004. UPI. FDA stays out of generic-branded drug feud.
• Jul 6, 2004. Leila Abboud for the Wall Street Journal. FDA Declines to Curb a Tactic Of Drug Firms Against Generics.
• July 3, 2004. Michael Yeomans for the Pittsburg Tribune-Review. Mylan wants the FDA to ban generic drug interference.
• December, 2000. Aiden Hollis, Department of Economics, University of Calgary. The Effect of Brand-Controlled “Pseudo-Generics” on the Canadian Pharmaceutical Market.

• June 28, 2001. CNNfn. Drug patent profit extended: Generic approval time grows, giving patent holders longer to reap earning.

• June 20, 2005. John Donnelly for the Boston Globe. AIDS drugs hit roadblock in Africa - Dispute over generics stalls treatment efforts.
• February 10, 2005. Marc Kaufman for the Washington Post. Biotech Drugs' Generic Future Debated: Medications Are Hard to Afford -- but May Also Be Hard to Copy.
• January 21, 2005. Harvey Bale, Director General of the IFPMA. Letter to the WHO Commission on Intellectual Property Rights, Innovation and Health, on Follow-on Pharmaceutical Patents.
• July 7, 2004. Cutting Edge Information press release. New Combination Drugs Ward-Off Generic Competition.
• June 26, 2004. Mukdawan Sakboon for the Thai Nation. Red Tape Is Blocking Access to Badly Needed Drugs.
• April 30, 2004. Sarah Lueck for the Wall Street Journal. White House Aims To Answer Critics Of Its AIDS Fight.
• March 25, 2004. The Economist. Me Too - Welcome new investment in the generic drug industry.
• July 16, 2003. Ben Hirschler for Reuters. U.S. says ready to use generic drugs in AIDS fight.
• March 1, 2003. Mamphela Ramphele and Nicholas Stern for the New York Times. Generic Drugs Can Make the Money Last.
• February 26, 2003. UN press release. UN welcomes drug companies’ pledge to expand access to generic essential medicines.
• February 18, 2003. Speech by Bill Haddad (CEO, Biogenerics, Inc.) at EC Brainstorming Meeting.
• January 27, 2003. Letter from President Bush to the Generic Pharmaceuticals Association.
• January 23, 2003. IMS Health. Generics Take Off in Brazil.
• January 16, 2003. Speech by Bill Haddad, (Chariman/CEO of Biogenics) to the EU Strategic Committee in Brussells.
• January 6, 2003. Inside Health Policy. Can patents not claiming substance in approved drug be listed? - GPhA, PhRMA Clash On Listing Of Some Drug Substance Patents.
• December 27, 2002. Milt Freudenheim for the New York Times. As Drug Patents End, Costs for Generics Surge.
• December 27, 2002. Kamran Reza Chowdhury for the Bangledesh Independent. Why not export more pharmacutical products?
• November 26, 2002. Financial Times editorial. Supply of copycat drugs fails to keep pace with demand.
• October 22, 2003. Reuters. FDA says Dr Reddy's generic drug Norvasc approvable.
• September 16, 2002. Richard Woodman for Reuters Health. Patents to Expire on Cancer Drugs.
• May 24, 2002. Medicins Sans Frontieres press release. HIV/AIDS Drug Deal in Ukraine Promotes Multinationals, Ignores Cheaper Generics That Could Treat More People.
• April 13, 2002. Nathan Ford and Ellen t-Hoen. Letter to the editor of the Lancet. Generic medicines are not substandard medicines.
• February 25, 2002. PhRMA Press Release. PhRMA, Health Care Advocates To Fight Efforts By Generic Industry To Jeopardize the Progress In Medical Research. Also, see the full statement of Richard Smith, PhRMA's Vice President of Policy and Research.
• January 31, 2002. Schneider Institute for Health Policy of Brandeis University. Report prepared for the Generic Pharmaceuticals Association. Use of Generics: A Prescription for Drug Cost Savings.
• January 8, 2002. Reuters. Paper: FTC Probes Drug Patent Listings.
• August 13, 2001. Bethany McLean for Fortune Magazine. A Bitter Pill. In-depth story on the patent expiration and legal battles surrounding prozac (Eli Lilly's blockbuster drug that lost patent protection August 2, 2001). Also contains a good explanation of the Hatch-Waxman Act.
• July 20, 2001. Gardiner Harris for the Wall Street Journal. Research Company Receives 2 Patents; Could Delay Generic Forms of Prilosec.
• July 16, 2001. Public Citizen press release and report. Pediatric Monopoly Extension for Drug Companies Badly Flawed, Gives Windfall Profits to Drugmakers and Drives Up Prices.
• June 2001. Timothy B. Coan and Ron Ellis. Report for USA Specialty Pharmaceuticals. Generic Biologics: The Next Frontier.
• June 4, 2001. Gumisai Mutume for the Inter Press Service. UN Chief Endorses Generic Drugs for Global AIDS Fund.
• April 17, 2001. Greg Aharonian for PR Newswire. Does Business Method Patent Prevent Generic Drug Competition?
• 1999. Gerald Mossinghoff for the Food and Drug Law Journal, Vol. 54, Number 2. Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process.
• December 20, 1998. Prepared by NERA, S J Berwin & Co and YRCR Ltd for the European Commission. Policy Relating to Generic Medicines in the OECD.
• September 1997. Fiona M. Scott Morton for the National Bureau of Economic Research. Entry Decisions in the Generic Pharmaceutical Industry.

Country Articles

• South Africa
  • November/December 1997, Rachael Burstein, Let them Eat Erthromycin, involves trademark disputes concerning generic drugs in South Africa.
• Malaysia
  • June 16, 2001. Brenda Lim for he New Straight Times. Price List of Drugs to Go Online.
• Finland
  • January 16, 2003. Helsingin Sanomat. Generic medicines bring changes to list of best-selling drugs in Finland.
• Japan
  • 1998, William T. Christiansen II, Patent Term Extention of Pharmaceuticals in Japan: so you say you want to rush that generic drug to market in Japan...Good Luck!
• Canada
  • October 26, 2001. Krista Foss for the Toronto Globe and Mail. You want to sell a generic drug that's safe and saves money. Should be simple, right? Not when you're up against a brand name like DuPont.
  • May 1, 2001. Andrew Duffy for the Ottowa Citizen. Drug delays waste millions: Study condemns slow approval of generic drugs
• USA
  • October 9, 2000, Jed Seltzer, in Reuters, Generics face steep fight with drug giants
  • CPT Page on Taxol. Includes information on a class action lawsuit against Bristol- Myers Squibb for delaying the market entry of generic Taxol, as well as extensive information on the government's role in the development of this blockbuster anti-cancer drug.
  • Alegra
    • July 3, 2001. PR Newswire. Aventis Pharmaceuticals Comments on ANDA Filing of Fexofenadine HCl 60 mg Capsules.
  • Augmentin
    • March 4, 2003. GSK press release. Paxil patent ruling issued.
    • March 4, 2003. Ben Hirschler for Reuters. Glaxo Loses Patent Case on Top Drug Paxil.
    • October 8, 2002. Associated Press. AFSCME Union Joins Drug Price Fight.
    • October 2, 2002. Reuters. New York Teachers Sue Glaxo Over Augmentin
    • October 2, 2002. Sky News. Glaxo Faces Patent Action.
    • September 19, 2002. NY State United Teachers press release. NYSUT files class action suit fighting rising prescription drug costs.
    • August 23, 2002. Associated Press. Glaxo Sues Generic Rivals.
    • May 24, 2002. Bloomberg News. Judge tosses out Glaxo patents for antibiotic: Allows rivals' low-cost versions.
    • May 23, 2002. GlaxoSmithKline press release. Federal District Court Rules in Augmentin® Patent Trial: GSK to Appeal Ruling.
  • Hytrin
    • December 28, 2001. Marsha Austin for the Denver Post. Coloradp AG sues 3 firms over drug.
    • July 23, 2000, Sheryl Gay Stohlberg and Jeff Gerth, in The New York Times, How Companies Stall Generics and Keep Themselves Health.
  • Prilosec
    • Stop Patient Abuse Now! website on Prilosec.
    • October 14, 2002. Rex Moore for the Motley Fool. A Patent Killing.
    • September 7, 2002. Ben Hirschler for Reuters. Can Prilosec Continue to Aid AstraZeneca?
    • August 8, 2002. Jed Seltzer for Reuters. Consumer Groups Ask for Probe of Prilosec Case.
    • June 6, 2002. Gardiner Harris for the Wall Street Journal. Prilosec's Maker Switches Users To Nexium, Thwarting Generics.
    • May 28, 2002. Jed Seltzer for Reuters. Prilosec Trial to Wrap Up.
    • May 13, 2002. Robert Langreth for Fortune. Hard to Swallow.
    • January 8, 2002. Jed Seltzer for Reuters. Prilosec trial to drag on, keeping generics at bay.
    • November 19, 2001. Rachel Zimmerman and Suzannah Rodgers. FDA Backs Marketing of Generic Version Of AstraZeneca's Prilosec by Andrx Corp.
    • November 16, 2001 Andrx Corporation press release. Andrx Receives Final FDA Marketing Approval for Generic Prilosec.
    • October 5, 2001. SPAN press release. Prilosec Patent Expires Tonight, But Legal, Regulatory Delays Will Cost Consumers Millions of Dollars.
    • July 20, 2001. Gardiner Harris for the Wall Street Journal. Research Company Receives 2 Patents; Could Delay Generic Forms of Prilosec.
  • Tamoxifen
    • May 30, 2002. Robert Pear for the Wall Street Journal. AARP Joins Three Lawsuits Against Large Drug Companies.
    • May 10, 2001. Melody Petersen in the New York Times. Suits Accuse Drug Makers of Keeping Generics Off Market.
    • December 31, 1998, Jayne O'Donnell in USA Today, article concerning DOJ investigation into possible price fixing agreement between Zeneca and Barr over Tamoxifen, arising out of the settlement of a 1993 patent infringement suit.
    • December 31, 1998, Barr Press Release, Barr Says Tamoxifen Patent Settlement Has Resulted in Significant Consumer Savings.
  • Tiazac
    • Stop Patietn Abuse Now page on Tiazac. Includes press release, news stories, and petition.
    • September 22, 2001. Leonard Zehr for the Globe and Mail. Biovail suffers legal setback.
  • Premarin
    • August 18, 1997, Citizens Against Government Waste, Premarin, Politics and the Public Health An Expose´ Revealing How Politics Trumped Science at the FDA. Here is the Press Release for the report.
    • July 21, 1997, Tom Schatz and Leslie Paige, Open Ed in Wall Street Journal, Politics Trumps Science at the FDA
    • May 6, 1997, Press Release, FDA Decision Recognizes Complexity Of Premarin Conjugated Estrogens. This is the statement by Wyeth-Ayerst Laboratories, a division of American Home Products Corp, the company that is seeking to keep generic forms of Premarian off the market.
    • May 5, 1997, FDA Press Release, FDA STATEMENT ON GENERIC PREMARIN. On May 5, 1997, the FDA also issued a FDA BACKGROUNDER ON CONJUGATED ESTROGENS, and issued a more detailed Memo on Approvability of a Synthetic Generic Version of Premarin.
    • April 2, 1997, Judy Mann, in the Washington Post, The Politics of Pharmaceuticals
    • November 5, 1996, Tom Cahill, FDA May Delay `Generic' Premarin.
  • Cardizem CD
    • September 29, 2001. David Ranii for the News and Observer. Generic drugs face legal hurdles.
    • August 1, 2001. AT-IP. Report on Andrx Pharmaceuticals, Inc., v. Biovail Corporation.
    • May 15, 2001. Sarah Webster for he Detroit News. Suit Charges Drug Conspiracy.
    • August 21, 1998, Class action lawsuit charging Andrx Pharmaceuticals, Inc., (Nasdaq: ADRX) Hoechst Aktinegesellschaft and Hoechst Marion Roussel, Inc. with conspiring to keep any generic competitor to Hoechst's leading hypertension medication, Cardizem CD. from coming to market.

      The lawsuit charges that "...in exchange for a bribe of $40 million per year from Hoechst, Andrx has entered into an agreement in restraint of trade with Hoechst to not sell its FDA-approved generic version of Cardizem CD in the United States.The lawsuit alleges that the purpose of the conspiracy between Hoechst and Andrx is to prevent any generic Cardizem CD from reaching the United States market, depriving all purchasers, including hypertension and angina sufferers, of the ability to purchase the drug at a fair price, thereby enabling Hoechst to maintain their dominance over once-a-day diltiazen, which lets them fix the price of Cardizem CD without competition.

      Apparently the FTC is also involved. (Reported by USA Today).
  • Warfarin.
    • December 17, 1998, Barr Press Release, Texas Judge Strikes Down Board of Pharmacy Anti-substitution Rule as Invalid; Barr Laboratories Successful in Court Challenge of DuPont Sponsored Restriction.
  • FTC Investigation into price fixing by Mylan.
    • December 21, 1998, FTC Press Release, Mylan, Nation's Second Largest Generic Drug Maker, Charged with Restraint of Trade, Conspiracy & Monopolization: Illegal Conduct Resulted in Price Increases of up to 3000 Percent for Two Anti-anxiety Drugs, FTC Alleges; Agency to Seek $120 Million in Consumer Refunds.

      The illegal activity allowed Mylan to dramatically increase the price of the two drugs used by millions of Americans, the Commission alleged. In January of this year, the company raised the wholesale price of clorazepate from $11.36 to approximately $377.00 per bottle of 500 tablets. And, in March, the wholesale price of lorazepam went from $7.30 for a bottle of 500 tablets to approximately $190.00

    • December 21, 1998, Mylan Press Release: Mylan Denies FTC Charge. Mylan also issued other press releases on December 22, 1998 and December 23, 1998.
    • December 22, 1998, Cambrex Press Release, Cambrex Corporation Responds to FTC Charges.
    • A number of law suits have been filed in this matter by state attorney generals and consumer class action cases.

• Generic Pharmaceutical Association.
• European Generic Medicines Association
• Stop Patient Abuse Now!