Find Information about a U.S. Drug Patent Extension?

TOPIC: In the United States the Drug Price Competition and Patent Term Restoration Act of 1984 permits extension of the patent or market exclusivity period to recapture those years that a drug spent under FDA review during valuation of the original NDA application. Some drugs are automatically granted market exclusivity in excess of their patent life. For actual patent life extensions, originating companies must apply to the USPTO within 60 days of NDA approval. The FDA is then asked for official authorization of the claimed review period.

The first public announcement from an official (govt.) source of a patent term extension application is publication in the Federal Register of the FDA’s validation of the product’s regulatory review period eligible for restoration to the patent term. Typically, Federal Register notices lag behind NDA approval by at least two years. The text and summary portions of records often cite the legislative authority behind documents published. In this case, the authority is searched both as a Public Law and also with keywords. The patent assignee and name of drug can also be used in the search.

In this example, using the Federal Register (File 180), you want to find information about U.S. drug patent extensions for Mivacron. The Federal Register is a daily publication of the U.S. government that serves to notify the public of official actions by Federal agencies like the Federal Drug Administration (FDA).

COMMAND SUMMARY

BEGIN 180
SELECT PUB?()(LAW OR L)()98()417
SELECT DRUG()PRICE()COMPETITION(1W)PATENT()TERM()RESTORATION
SELECT S1 OR S2
SELECT S3 AND MIVACRON
TYPE S4/9/1

HOW TO...

RELATED HOW DO I...? SOLUTIONS

• Find clinical trials for a specific drug for a particular indication?
• Find a CAS Registry number for a drug?
• Find a U.S. trademark for a drug?
• Find a peer-reviewed chemical literature for a specific drug for a particular indication?
• Find top pharmaceutical drugs by sales for a particular year?

NEED HELP?

Contact the Dialog Knowledge Center
Within North America 1 800 3 DIALOG (334 2564)
Outside North America 00 800 33 DIALOG (33 34 2564)
Web Form www.dialog.com/contacts/webform

Stock #: 53318; Last modified: 14 Sep 2011

top