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Generic drugs

Generic Drugs

Rameshwar Reddy's picture
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“ GENERIC DRUGS” are the off patent drugs which are introduced into the market upon the expiry of the patent having the identical BIO-EQUIVALENCE”(Pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered to patients or subjects at the same molar dose under similar experimental conditions of the branded drug.)
They are boon and unequivocally Bane too.
BOON: They are safe and effective alternatives to brand name prescriptions
• Can help both consumers and the government reduce the cost of prescriptiondrugs
Factors Driving the Generics Growth:
Consumers becoming increasingly sensitive to pharmaceutical costs and aware of safety and efficacy standards for Generic products
Direct-to-consumer advertising is furthering the awareness and propensity towards generic substitution

FDA Efforts For Faster Approval Of Generic Drugs

sai's picture
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There's a huge backlog at the FDA's OGD, which has seen the number of submitted applications increase by 150 percent

According to the FDA, fewer generics are being approved for two reasons:

A shortage of personnel

and the number of faulty applications that generic companies submit.

OGD needs up to 100 more employees over the next three years to eliminate the build up--a move that would cost between $16 million and $19 million a year.

More funding to the Office of Generic Drugs (OGD) seems to be more logical option to improve adminstrative efficiencies.

Authorized generics : Is it good or bad ?

sai's picture
0

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

"Authorized generic drugs" are generic drugs from branded companies. Aka copycat version of their own brand drug. You will be wondering why do they (brand companies) do that. This way branded companies still make money even though their patent expires.