As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts. Must be careful in its development process to avoid trade dress infringement issues.
Sure, tablet and capsule size and shape may influence patient compliance, and color sameness may make it easier for pharmacist and patients to recognize potential medication dispensing errors, but OGD must also be cognizant of the legal implications of their directives or desires. It is certain that there will be additional flexibility if generic companies can fully justify differences and OGD determines that the difference will not likely impact substitution problems.
Let the developer beware! Your efforts are being watched by more than the FDA!
