GENERIC DRUGS :

A generic drug is a medication created to be identical or bioequivalent to an already

marketed brand-name drug.

Key benefits: Significantly cheaper, FDA-approved, same quality standards, Increased access to healthcare.
ANDA: Key to Affordable Generic Drugs
ANDA (Abbreviated New Drug Application): the gateway for bringing affordable generic drugs to market. Here's how: Faster &
Cheaper , Safe & Effective , Lower Prices , Wider Access.
Hatch-Waxman Act: Balancing Innovation & Affordability :
1984 law impacting US pharmaceuticals:
Faster, cheaper generics: ANDA pathway eases approval for proven bioequivalent drugs.
Rewards innovation: Market exclusivity for brand-name drugs incentivizes R&D.
Balance: Patent challenges & extensions aim to balance both interests.
Results:
Lower drug prices: Generics save billions, increasing access to medication.
Innovation continues: Brand-name incentives drive new drug development.
Types of Patent Certification :
When an application submits an ANDA to the FDA, the applicant must certify one of four things under Section 505(j)(2)(a)(vii):
Para I certificate- no patent information has been submitted to FDA.
Para II certification- That submitted patents relevant to drug have expired.
Para III certification- that the patent will expire on particular date.
Para IV certificate- if applicant certifies that any used patent is invalid or will not be infringed by the generic drug.