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Availability and Regulatory Status of Major Antiretroviral Drugs (September 2009)

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Availability and Regulatory Status of Major Antiretroviral Drugs (September 2009) Availability and regulatory status of major antiretroviral drugs (September 2009) Medium price per patient per year (in U$) Suppliers International Preferred 2008 Dosage Nonproprietary Strengths form Lower Upper Name (INN) (adults) Low income Middle Middle Originator Generics income income Aurobindo Pharma Ltd.; Cipla Ltd.; Eastern Surgical Company; Emcure; Hetero Drugs 317 a 370 Ltd.; Laboratorio Elea S.A.C.I.F.y A; Abacavir tablets 300 mg 350 a GlaxoSmithKline (286-370) (353-401) Laborotorios Filaxis Argentina; Laborotorios (313-374) Richmond S.A.C.I.F; Matrix Laboratories Ltd.; Ranbaxy Ltd; Strides Arcolab Ltd. 238 a Matrix, Ranbaxy, Hetero; Cipla; Aurobindo; Tenofovir tablets 300 mg 166 a 207 a Gilead Sciences (238-420) Emcure; Aspen; Strides Arcolab Ltd. (151-207) (177-256) Apotex Mexico (Protein, S.A. de C.V.); Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Cristalia, productos quimicos 212 a 462 Bristol-Myers farmaceuticos Ltda.; Emcure; Hetero Drugs 100 mg 251 a (187-235) (242-1100) Squibb Ltd.; Laboratorio Dosa S.A; Laborotorios (187-310) Filaxis Argentina; Laborotorios Richmond buffered S.A.C.I.F; Ranbaxy Ltd.; Zhejiang Huahai tablets Pharmaceutical Co., Ltd. 208 b Bristol-Myers Aspen Pharmacare Ltd.; Aurobindo Pharma 150 mg Didanosine (172-244) Squibb Ltd.; Cipla Ltd. Aurobindo Pharma Ltd; Barr Laboratories, Inc; 242 a 238 a 220 Bristol-Myers 200 mg Cipla Ltd.; Laborotorios Richmond S.A.C.I.F; (197-310) (233-794) (217-235) Squibb Macleods Pharmaceuticals Ltd.; Ranbaxy Ltd.; 242 a 238 a 220 Bristol-Myers 200 mg Aurobindo Pharma Ltd; Barr Laboratories, Inc; (197-310) (233-794) (217-235) Squibb EC 223 799 997 Bristol-Myers Aurobindo Pharma Ltd.; Barr Laboratories, 250 mg capsules (214-223) (675-874) (613-997) Squibb Inc; Cipla Ltd.; Ranbaxy Ltd.; 288 1267 a 1269 Bristol-Myers Aurobindo Pharma Ltd.; Barr Laboratories; 400 mg (279-288) (507-1302) (1129-1386) Squibb Hetero Drugs Ltd.; Cipla Ltd.; Ranbaxy Ltd. Medium price per patient per year Suppliers International Preferred (in U$) 2008 Dosage Nonproprietary Strengths Lower Upper form Low Name (INN) (adults) Middle Middle Originator Generics income income income Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd; Cambogia Pharmaceutical Enterprise; Cipla Ltd.; Cosmos Ltd.; Cristalia, productos quimicos farmaceuticos Ltda.; Danpong-Adams Pharmaceutical Industry Ltd; Eastern Surgical 37a 40 a 48 a Company; Emcure; Hetero Drugs Ltd.; 150 mg GlaxoSmithKline (37-48) (37-45) (45-383) Laboratorio Dosa S.A; Laboratorio Elea Lamivudine tablets S.A.C.I.F.y A; Laborotorios Filaxis Argentina; Laborotorios Richmond S.A.C.I.F; Matrix Laboratories Ltd.; Neto Machado, Labogen SA; Ranbaxy Ltd.; Strides Arcolab Ltd.; The Government Pharmaceutical Organization; 59 b 61 b Aurobindo Pharma Ltd.; Cipla Ltd; Strides 300 mg GlaxoSmithKline (59-59) (55 - 66) Arcolab Ltd. Apotex Mexico (Protein, S.A. de C.V.); Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; 242 a 249 a 249 a capsules 250 mg GlaxoSmithKline Combino Pharm S.L.; Eastern Surgical Company; (242-242) (243-253) (243-253) Laboratorio Dosa S.A; Laborotorios Filaxis Argentina Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; Zidovudine Cambogia Pharmaceutical Enterprise; Cipla Ltd.; Combino Pharm S.L.; Cosmos Ltd.; Danpong- 103 a 104 a 113 a Adams Pharmaceutical Industry Ltd; Eastern tablets 300 mg (99-107) GlaxoSmithKline (99-114) (109-118) Surgical Company; Emcure; Hetero Drugs Ltd.; Matrix Laboratories Ltd; Ranbaxy Ltd.; The Government Pharmaceutical Organization; Xiamen Mchem Pharma Group Ltd. gel 497 a 1107 a ,e 994 a ,e 133/33 mg Abbott Laboratories Hetero Drugs Ltd.; Matrix capsule (429-511) (544-1122) (586-2016) Lopinavir/ritonavir heat 500 a 1036 a, e 1391 a, e stable 200/50 mg Abbott Laboratories Matrix; Aurobindo Pharma Ltd (500-535) (740-1180) (679-4210) tablet Medium price per patient per year (in U$) Suppliers International Preferred 2008 Dosage Nonproprietary Strengths Lower Upper form Low Name (INN) (adults) Middle Middle Originator Generics Income Income Income 2737 2704 2210 a Cristalia, productos quimicos farmaceuticos Ltda.; capsules 200 mg Roche (1350-3000) (2410-2767) (2164-2257) Laborotorios Richmond S.A.C.I.F; Saquinavir 1587 b tablets 500 mg Roche (968-2205) 469 511 Bristol-Myers 150 mg Emcure Pharmaceuticals Limited (450-488) (511-511) Squibb Atazanavir capsules 487 b Bristol-Myers 200 mg (439-534) Squibb Emcure Pharmaceuticals Limited 3215 1284 Fos-amprenavir tablets 700 mg GlaxoSmithKline (1430-5000) (1284-1287) 84 283 a 329 a Cipla Ltd.; Cristalia, productos quimicos farmaceuticos Ritonavir capsules 100 mg Abbott Laboratories (83-114) (99-811) (313-346) Ltda.; Hetero Drugs Ltd.; Strides Arcolab Ltd. Cipla Ltd.; Cosmos Ltd.; Eastern Surgical Company; Emcure; Hetero Drugs Ltd.; Laboratorio Dosa S.A; 406 446 a 538 a Merck Sharpe & Indinavir capsules 400 mg Laboratorio Elea S.A.C.I.F.y A; Laborotorios Filaxis (350-445) (389-457) (439-636) Dohme Argentina; Laborotorios Richmond S.A.C.I.F; Macleods Pharmaceuticals Ltd.; Ranbaxy Ltd.; Strides Arcolab Ltd Cipla Ltd.; Danpong-Adams Pharmaceutical Industry Ltd; Eastern Surgical Company; Hetero Drugs Ltd.; 1322 2631 a 250 mg 4840 a Roche Laboratorio Dosa S.A; Laboratorio Elea S.A.C.I.F.y A; Nelfinavir tablets (1248-1928) (2258-2631) (1470-4840) Laborotorios Filaxis Argentina; Laborotorios Richmond S.A.C.I.F; Macleods Pharmaceuticals Ltd. 625 mg 9198 c Roche (a) Prices extracted from WHO Global Price Report Mechanism - (http://www.who.int/hiv/amds/price/hdd/index.aspx,) accessed in May 2007; (b) Prices extracted from MSF drug price database for developing countries - "Untangling the web of price reductions" - 10th Edition - July 2007 (www.accessmed-msf.org/documents/Untangling10.pdf ); (c) Price extracted from POC-IT HIV Drug Guide - Johns Hopkins University - USA ( http://www.hopkins-hivguide.org/drug/index.html?navigationId=7591&siteId=7151) , assessed in May 2007; (d) GlaxoSmithKline information (press release - http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=840 ); (e) In 2007, a public announcement from Abbott laboratories have informed that the price of LPV/r capsules and tablets was be reduced to U$ 1,000 per patient per year in low- middle income countries (http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0442.htm ). Annex 2: Regulatory status of recommended 2nd line of antiretroviral drugs (September 2009) International Registration number in priority countries Nonproprietary (114) Formulation WHO FDA EMEA Name (INN) Originator Generics GlaxoSmithKline, Ranbaxy Cipla Ltd; Aurobindo tablets Laboratories Pharma Ltd; Matrix Abacavir GlaxoSmithKline 80 28 (300 mg) Ltd, Cipla Ltd, Matrix Laboratories Ltd, Laboratories Ltd GlaxoSmithKline; Aurobindo, Pharma tablets Cipla Limited, Gilead Ltd., Cipla Limited, Tenofovir Gilead Sciences, Inc. 67 14 (200 mg) Sciences, Inc. Gilead Sciences Inc., Matrix Laboratories Ltd buffered tablets Aurobind,o Pharma Ltd, Bristol Myers Squibb Bristol Myers Squibb 32 39 (100 mg) Bristol Myers Squibb buffered tablets Aurobindo Pharma Ltd, Bristol Myers Squibb Bristol Myers Squibb 31 13 (150 mg) Bristol Myers Squibb buffered tablets Aurobindo Bristol Myers Squibb Bristol Myers Squibb 14 13 (200 mg) Bristol Myers Squibb Didanosine EC capsules Aurobindo 1 (200 mg) EC capsules Aurobindo, Pharma Ltd, Bristol Myers Squibb Bristol Myers Squibb 29 2 (250 mg) Bristol Myers Squibb EC capsules Aurobindo, Pharma Ltd, Bristol Myers Squibb Bristol Myers Squibb 29 1 (400mg) Bristol Myers Squibb Alkem Laboratories Cipla Ltd; GlaxoSmithKline Ltd, GlaxoSmithKline; Aurobindo, Matrix Hetero Drugs Ltd; Laboratories Ltd; tablets Macleods Hetero Drugs Ltd; GlaxoSmithKline 55 63 (150mg) Pharmaceuticals Ltd; Aspen Pharmacare Ltd; Aurobindo; Matrix Lamivudine Ranbaxy Laboratories; Laboratories Ltd. Strides Arcolab Ranbaxy Laboratories Aurobindo; Macleods tablets Aurobindo; Matrix Pharmaceuticals Ltd; 2 17 (300mg) Laboratories Litd Hetero Drugs Limited Registration number in priority countries International (114) Nonproprietary Formulation WHO FDA EMEA Name (INN) Originator Generics capsules Combino Pharm S.L. Combino Pharm S.L. GlaxoSmithKline 75 8 (250mg) GlaxoSmithKline GlaxoSmithKline Matrix Laboratories Ltd; Hetero Drugs Ltd; Matrix Cipla Ltd; Combino Pharm Zidovudine Laboratories Ltd; tablets Aspen Pharmacare Ltd Combino Pharrm, Ranbaxy Laboratories 74 52 (300mg) GlaxoSmithKline GlaxoSmithKline Aurobindo Pharma Ltd; Ranbaxy Laboratories GlaxoSmithKline Aurobindo Pharma Ltd gel capsules Abbott Laboratories Abbott Laboratories Abbott Laboratories 89 1 (333/33 mg) Lopinavir/ritonavir Matrix Laboratories Matrix Laboratories Ltd, heat stable tablets Limited, Abbott Aurobindo Pharma Ltd, Abbott Laboratories 50 3 (200/50 mg) Laboratories Abbott Laboratories capsules Roche Roche Roche 20 1 (200 mg) Saquinavir tablets Roche Roche Roche 5 0 (500 mg) capsules Emcure Pharmaceuticals Atazanavir Bristol-Myers Squibb 6 1 (150 mg) Ltd; Bristol-MyersSquibb tablets Fos-amprenavir GlaxoSmithKline GlaxoSmithKline 5 0 (700 mg) capsules Ritonavir Abbott Laboratories Abbott Laboratories Abbott Laboratories 70 9 (100 mg) capsules Hetero Drugs Limited; Indinavir Merck Sharpe & Dohme Merck Sharpe & Dohme 88 46 (400 mg) Merck Sharpe & Dohme tablets Nelfinavir Roche Roche Roche 55 18 (250 mg) .
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