Drugs brand name

Brand name drug Clinical trial Deception Discontinued drug Drug interaction... 

A brand name drug is a drug marketed under a proprietary, trademark-protected name. 

Third, a more rapid rafe of sales erosion in brand name producfs was observed in fhe case of more recenf pafenf expirations. This is especially so for fhe fop selling drug products which attract the most intensive generic competition. Three recent cases illustrate this phenomenon. Generic enalapril, laxmched in August 2000 as a substitute for the brand name drug Vasotec , obtained 66.4% of new prescriptions just 4 weeks after its launch. 

Therapeutic classes with three or more leading brand-name drugs in 2003. 

At the same time, expenditures on pharmaceutical products continue to grow and often outpace expenditures for other consumer products. Pharmaceutical expenditures concern not only consumers, but government payers, private health plans, and employers as well. Generic drugs offer opportimities for significant cost savings over brand-name drug products. 

The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. The study does not address other procedures for generic entry, and it does not address the patent restoration features of Hatch-Waxman. 

The brand-name drug products included in the study represent some of the largest drug products as measured by annual sales. They include blockbuster drugs such as Capoten, Cardizem CD, Cipro, Claritin, Lupron, Neurontin, Paxil, Pepcid, Pravachol, Prilosec, Procardia XL, Prozac, Vasotec, Xanax, Zantac, Zocor, Zoloft, and... 

Several brand-name drug companies have equity interests in generic subsidiaries and, thus, were requested to answer questions relating to both brand-name products and generic products. 

Before deseribing the seope of the study, it is important to understand the historical context in whieh Hateh-Waxman arose. Moreover, the generie approval process Hatch-Waxman implemented demands an understanding of the interaction of the patent system and the regulatory structure governing the approval of brand-name drugs. 

Those seeking to market a generic version of an existing post-1962 brand-name drug also had to perform their own safety and efficacy studies, much like the brand-name companies had to demonstrate the safety and efficacy of the brand-name dmg. The FDA did not have a streamlined... 

The FDA did establish, however, a procedure to determine the effectiveness of all drugs approved prior to 1962, and it established a policy of permitting the approval of a generic equivalent to a safe and effective pre-1962 brand-name drug. This generic approval procedure, however, did not apply to drugs approved after 1962. Id. 

According to the FDA, from the time Hatch-Waxman became effective in 1984 through December 31, 2000, 8,019 ANDAs were filed wifh the FDA." Of these applications, 7,536 (94 percent) raised no patent issues (i.e., the ANDAs did not contain a paragraph IV certification). A substantial portion of the total number of ANDAs, however, relate to the same brand-name product or NDA. Thus, the total number of ANDAs does not represent 8,019 unique brand-name drug products, and it is unclear as to how many unique brand-name drug products the total 8,019 ANDAs related. 

Four hundred eighty-three (483) (or six percent of the total number of ANDAs filed) contained Paragraph IV certifications. The 483 ANDAs relate to 130 unique brand-name drug products as measured by unique NDAs. The share of ANDAs with paragraph... 

For 1 of the 29 drug products, 2 different generic applicants were the first to file for each of the 3 different strengths of this drug product. In each strength, the brand-name company did not sue the generic applicant. As noted above, this brand-name drug product is only coimted once in the total of 29. 

The patents eovering the 22 brand-name drug produets in whieh the generic applicant prevailed involved formulation or method of use patents. In 3 instances (out of 6 where a drug substanee patent was at issue), a drug substanee patent was found invalid or not infringed. 

In light of the confidential nature of many of the provisions of these settlements, the following discussion has been written to ensure anonymity. Each lettered drug product corresponds to a distinct brand-name drug product. 

Among the license agreements described in Table 3-2, the four agreements with waiting periods (A, E, F, and H) related to brand-name drug products in which there was not yet a second generic applicant for the drug product as of January 1, 2001. 

One of the cross-royalty provisions provided the generic company with a 1 percent royalty on net sales of the brand-name drug product. Thus, the brand payment was in the form of a royalty on the brand-name drug company s drug product. 

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