Generic Medicine, and its Marketing Procedure?
Generic medicine is the medicine which is manufactured as the same as already established branded marketed product and show the same quality, performance, route of administration, strength, safety, efficacy, potency even same bioequivalence. The mechanism of action is the same as the branded medicine. In simple way you say as the substitute of the branded medicine and you will get the same benefit as branded medicine.
How it work the same as brand-name medicines?
All type of generic medicine must show the same biological activity as the established branded medicine in terms of safety, efficacy, potency, strength, dosage form, route of administration and labelling also. The generic medicine must meet the same quality standard as branded medicine.
As the generic medicine use the same active ingredient as the branded medicine so it work the same as the braded medicine perform the defined job. The generic must undergo the strict review by the competent authority and the authority must visit and audit the manufacturing and testing facility of the respective pharmaceutical firm and approved the generic medicine for the market
It may not the carbon copy of the branded medicine and a minor difference may be accepted in terms of inactive ingredients but the potency may not vary in significant amount. There is also a permutable limit to handle this case. Most of the cases this generally not more than 3.5% from the label claim.
This minor difference may be seen in batch to batch in branded medicine same as generic medicine. When the generic medicine is produced in commercial grade then minor variation may occur in purity, safety, efficacy, potency, strength etc. but not in significant amount and this minor limit is always acceptable.
Why Generic medicine looks different from the brand medicine?
The trademark law doesn’t allow the similar looking product in the market. As the brand medicine is present in the market so generic medicine can’t present in the same. The brand medicine and the generic medicine contains the same Active pharmaceutical ingredient but their color, flavor and other characteristics which didn’t directly affect the quality, safety, potency and efficacy may be different.
Why cost is less than the brand medicine?
To develop a brand medicine the pharmaceutical farm or other research firm have to invest a great amount of cost and they have to submit the animal and clinical studies to the competent authority for the approval process but the generic medicine producer don’t face this type of investment. They have to produce the same brand medicine with so called little investment. The price in this case dawn to (80~85)% compare to brand medicine.
The generic medicine is just the copy of the brand medicine and patient get it less cost and this cost down to least when multiple company produce the same generic medicine for the same target market. In this case strong regulation may impose the market to prevent the substandard generic medicine.
The manufacturing firm must submit an abbreviated new drug application (ANDA) to the competent authority for the approval of generic medicine stated that the generic medicine has the same the brand medicine. The applicant must show that the generic medicine is the same in terms of following condition-
To be confirm that generic medicine is the same as brand medicine
- Must have the same strength as the brand medicine
- It contains the same dosage form as product as brand product
- It has the same route of administration as the brand product
- It must contains the same inactive material
- It must manufacture in the same facility as brand medicine
- The stability of the must be same as brand medicine
- Container closure system must be appropriate
- label must be same as the brand medicine
Example of different Brand-Name medicine with Generic Name and Available Marketed Product
| Brand Name-Medicine | Innovator | Generic Name | Available Marketed Product |
|---|---|---|---|
| Altace | Hoechst AG | Ramipril | Cardace, Cardiopril, Ramipres |
| Amaryl | Hoechst Marion Roussel | Glimepiride | Duetact, Azulix, Diaglim |
| Ambien | Sanofi Aventis | Zolpidem | Zolfresh, Sobrium, Sove |
| Ativan | Pfizer | Lorazepam | Calmese, Lopez, Trapex |
| Calan sr | Farbwerke Hoechst AG | Verapamil sr | Calaptin, Vasopten, Veramil |
| Celexa | Klaus Bøgesø | Citalopram | Citadep, C-Pram, Citara |
| Coumadin | Karl Link and Harold Campbell | Warfarin | Sofarin, Uniwarfin, Warf |
| Diabeta | Squibb & Sons | Glyburide | Glybovin, Glinil, Daonil |
| Dilantin | Heinrich Biltz | Phenytoin | Celetoin, Dilantin, Garoin |
| Effexor | Pfizer | Venlafaxine | Alium, Flavix, Sentosa |
| Flonase | Sir David Jack FRS | Fluticasone | Flomist, Fluticone, Nasocom |
| Fosamax | Merck | Alendronate | Alant, Bifosa, Restofos |
| Glucophage | Jean Sterne | Metformin | Glumet, Emnorm, Formin |
| Glucotrol | Pfizer | Glipizide | Diacon, Glez, Glide |
| Hytrin | Abbot | Terazosin | Olyster, Teradip, Terapress |