The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry?
نویسندگان
چکیده
• Innovator drugs are given their own brand name and a common generic name that is shared with products certified as bioequivalent by a regulatory authority. • Characteristics—including names—that uniquely identify a seller’s product are entitled to legal protection against misappropriation. • Well-controlled studies and decades of use reveal that generic drugs approved by the Food and Drug Administration and European Medicines Agency are interchangeable with their innovator counterparts. • Widespread use of brand names persists within health care systems even after market exclusivity ends on those products, resulting in wasteful expenditures on products for which substantially cheaper, generic equivalents are available. • Allowing generic products to share the brand names of their corresponding innovator products could help reduce health care spending but would not prevent manufacturers from promoting their products or physicians from ensuring manufacturer-specific dispensing.
منابع مشابه
Teva v. Eisai: what's the real "controversy"?
The current system of regulating the multi-billion-dollar pharmaceutical industry via market exclusivity comes from the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The statute creates the framework for controlling the entry of generic drugs by a notification and certification system that heavily relies on the "Approved Drug Products with T...
متن کاملBrand-name drug manufacturers risk antitrust violations by slowing generic production through patent layering.
Patents on many blockbuster drugs will expire in the near future, opening up the doorways for generic production. Brandname drug companies lose an estimated half of their U.S. sales during the first six months of generic production alone. In an effort to forestall large sales declines, some brand-name pharmaceutical companies are scrambling to delay generic production. One measure brand-name ph...
متن کاملProduct-line extensions and pricing strategies of brand-name drugs facing patent expiration.
OBJECTIVE This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated wit...
متن کاملThe concept of: Generic drugs and patented drugs vs. brand name drugs and non-proprietary (generic) name drugs
Time and again the importance of generic prescribing has been emphasized, primarily to reduce the cost of drugs (Mukherjee, 2013). There are two concepts to be understood here, one is generic vs. patented drugs and the other is a drug’s “brand name” vs. “non-proprietary name” or “generic name.” Although, our article primarily describes the Indian scenario, it can be extrapolated to other countr...
متن کاملRecent trends in brand-name and generic drug competition.
OBJECTIVE To provide evidence on recent trends in: (1) market exclusivity periods (MEPs, the time between launch of a brand-name drug and its first generic competitor) for new molecular entities (NMEs); (2) the likelihood and timing of patent challenges under Paragraph IV of the Hatch-Waxman Act; and (3) generic drug penetration. METHODS IMS Health National Sales Perspectives data were used t...
متن کامل