2003 a strong year for generic approvals

2003 is turning out to be a positive year for generic drug approvals.


2003 a strong year for generic approvals

So far, 2003 is turning out to be a positive year for generic drug approvals. January started out strong with 65 dosage-form approvals and 33 chemicals approved, according to data obtained from Totowa, N.J.-based E. W. Thwaite Associates, a pharmaceutical consulting firm. February approvals slacked off slightly, with 41 dosage and 23 chemical approvals. The upward trend continued with 38 chemical and 74 dosage forms approved in March. April witnessed 31 chemical and 63 dosage forms approved, and May saw 24 chemical and 49 dosage-form approvals granted by the Food & Drug Administration.



First-time generic approvals by the FDA in 2003

GenericBrandNo. of dosage formsCompany
Etidronate disodiumDipronel2Genpharm
Loratadine OTCClaritin1Geneva
Strontium chl. inj.Metastron1Bio-Nucleonic
LoratadineClaritin Redi-Tabs1Wyeth
Loratadine/pseudoephedrine sulfateClaritin D-24 ER1Andrx
Acetaminophen w/codeine phos. tabletsTylenol2Andrx
Amphetamine & dextroamphetamineAdderall3Barr
Cefadroxil oral susp.Duracef3Ranbaxy
Ipratropium bromide nasal solutionAtrovent2Dey
Metformin ERGlucophage ER1Teva
Norepinephrine bit. inj.Levophed2Gensia Sicor
Promethazine HCl supp.Phenergan1G&W
Carbinoxamine maleate oral sol.Clistin Elixir1Mikart
Dexamethasone sodium phos. inj.Dexamethasone1APP
Dihydroergotamine mesylate inj.D.H.E. 45 Injection1Paddock
Minocycline HClMinocin3Par
Naproxen sod. ERNaprelan1Andrx
Tizanidine HClZanaflex2Barr
Betamethasone dipropionate gelDiproplene Gel1Altana
Brimonidine tartrate ophthalmic sol.Alphagan Ophth. Sol.1Bausch & Lomb
Moexipril HCl tabletsUnivasc2Teva
Quinapril HCl tabletsAccupril4Teva


While the number of approvals was down 9% compared with May of last year, approvals are up sharply compared with the same time period for 1997 through 2001. Leading the generic approvals in 2003 was Andrx, with 14 chemical and 29 dosage forms approved by the FDA. Ranbaxy, Barr, Altana, and Roxane rounded out the top five, accounting for 30% of all 2003 year-to-date ANDA approvals. Edward Thwaite, president of E. W. Thwaite Associates, said that the surge in generic approvals could be attributed in part to the FDA's investment of additional resources behind ANDA approvals and to the political pressure relating to generics, which, Thwaite said, are by definition less costly. Another factor contributing to the rise in ANDA approvals, according to Thwaite, can be attributed to recent FDA action that has resulted in a number of streamlining approaches designed to speed up the approval process. Thwaite noted that the bigger the generic company, the more professional and thorough its ANDAs tend to be. And that, he commented, translates into quicker approvals.


Generic ANDA Approvals

YearNo. of chemicalsNo. of dosage forms


Doug Long, VP of industry relations for IMS, a market research firm specializing in the pharmaceutical industry, commented that generic approvals have been on the upsurge in recent years due to two factors: the loss of patent protection for many big branded products and the fact that brand manufacturers have been, up until recently, in an innovation drought. Long noted that there were only 17 new molecular entities approved last year—the lowest since 1983. In addition, Long commented, retailers make higher margins on generics so they want to convert the brands to generics as quickly as possible. He added that rising copayments for brands help to make generics more attractive pricewise.


Leading 2003 company approvals

CompaniesNo. of chemicalsNo. of dosage forms


What does the future hold for generic approvals? Don't expect anything dramatic and remarkable, cautioned Thwaite. However, he did suggest that the upward trend is likely to continue. "We're going to see a speed-up in approvals, even though it might not be easily recognizable or observable."

IMS' Long is confident that generics will continue to grow. "But unless some of these patent challenges are successful, you're not going to see the big increase that you saw in 2001, 2002, and early in 2003."

Anthony Vecchione


Tony Vecchione. 2003 a strong year for generic approvals. Drug Topics Generic Supplement;147:14s.