Generic manufacturers

A generic manufacturing process for PAG involves the addition of base to aluminum chloride solution... 

The generic manufacturer may not place a copy of either the original product or the new pharmaceutical form on the market for a period of 11 years after the approval of the original product (i.e. 10 years + 1 year added to the global market exclusivity period, because of new indications). 

The generic manufacturer may not submit an ANDA for the original product until 5 years after approval of the original form. 

The generic manufacturer may not submit an ANDA for the new pharmaceutical form until 11.5 years after approval of the original product (i.e. 5 years from the date of approval of the new form + 0.5 years for the paediatric application). 

When a generic manufacturer completes an Abbreviated New Drug Application (ANDA), the bioequivalency test data are highly likely to be the section... 

For generic bioequivalence the generic manufacturer would be expected to use the same chiral material as the innovator (most probably a racemic mixture or pure active isomer, though it is possible that in some rare instances the innovator might have discovered a valid reason for using some mixture of R and S other than 50/50). Thus, as with development bioequivalency, it would not normally seem necessary to use stereoselective assays for the separate determination of R and S isomers. However, one can conceive of possible situations where clinically significant differences in R-to-S ratios could be caused by even relatively small differences in absorption rate [6,7]. 

Bristol-Myers Squibb licensed its AIDS drug, Reyataz, free of charge to two generic manufacturers in South Africa and India. This decision will make available the generic form of the drug to sub-Saharan Africa AIDS victims at affordable prices. Reyztaz was first marketed in the United States in 2003 and its patent expires in 2017. 

Pharmacokinetic studies are so important in the pharmaceutical arena, that they play the central role in FDA approval of generic versions of drugs. A generic drug manufacturer has to demonstrate to the FDA s satisfaction a capability to manufacture the drug with appropriate levels of quality. But beyond that, the generic manufacturer need... 

Cir. 2001) Glaxo Group, Ltd v. Ranbaxy Pharms., Inc., 262 F.3d 1333, 1338 (Fed. Cir. 2001) (discussing district court s decision to grant preliminary injunction because generic manufacturer could not pay NDA holder s potential damages) see Chisum on Patents, 20.04(e)(iv) (Matthew Bender). 

Because some additional uses may only be discovered late in a drug s patent life (or even after the patent has expired), a company may be reluctant to spend the time and money to obtain formal FDA approval of new uses primarily to benefit generic manufacturers. Optimal medical practice, however, calls for access to sound and persuasive data on new indications. Some method needs to be foimd to encourage sponsors to seek new indications during more of a product s patent life and - if possible - beyond. 

The Hatch-Waxman Act dramatically altered the nature and terms of generic competition after 1984. First, the Act established an Abbreviated New Drug Application (ANDA), which substantially reduced the cost of generic entry. Second, the Act allowed generic manufacturers to conduct their testing prior to patent expiration. This allowed generics to enter the market much more quickly after patent expiration than previously. 

The purpose is to evaluate the bioburden, spore bioburden, and endotoxin present on rubber stoppers and unprocessed glass vials. The similarity of contents and equipment may be coincidental as the similar and common inventory are used by the generic manufacturers. 

Most of the top 25 companies are involved in discovery research targeted at the synthesis of new chemicals with new chemical structures, new modes of action and low rates of application that can be protected by international patents and that will give the inventing company an advantage over its competitors. Other generic manufacturers also invest in research but this is more applied in terms of manufacturing opportunities and formulation advances. 

Developing stability data for an ANDA product generally requires fewer laboratory studies than those required with an NCE. The primary goal of an ANDA should be to mimic the stability profile of the innovator product, barring any intellectual property issues that might prevent the generic manufacturer from formulating a sim-... 

---