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BioPharma News Digest Intellectual property Innovator vs. Generic: The Interplay of Patent Delisting and 180-day Market Exclusivity Cynthia H. Zhang About the Author: Dr. Cynthia H. Zhang is Director.

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Exclusive rights: Patents provide you with an exclusive right to prevent or stop others from commercially exploiting an invention for twenty years from the date of filing of the patent application.

Loss of exclusivity (LOE) is a natural milestone in a drug's lifecycle. Focused and effective late lifecycle management can preserve meaningful value for the brand. Kellogg's Corn Flakes had “generic” competition within a month of its launch more than 100 years ago, and yet it's still the dominant brand in its market.

During examination of a pending patent application or after the patent is granted, the owner of the patent may change: 1) the original owner may transfer ownership to another entity or party, through an "assignment;" or 2) the original owner may retain ownership but change its name.

Patent protection lasts 20 years from the application date, but can be extended to 28 years. Market exclusivity begins on the drug's approval date and lasts 5 years, but this duration can be extended up to 12.5 years, based on the drug type and other extension factors.

• Form FDA 3542 – Used to submit patent information on a patent that. claims the following: • An approved drug. • An approved method of using the drug. – Submitted upon approval of an NDA or supplement.

The main criterion for the inclusion of a product in the Orange Book is that it has an NDA or abbreviated new drug application (ANDA) that has been approved and that has not been withdrawn for safety or effectiveness reasons or determined by FDA to have been withdrawn for safety or effectiveness reasons.

Exclusivity periods typically last five years, though this might vary depending on one's locality. Once the exclusivity period ends, other pharmaceutical companies can obtain technical information to manufacture variants of the drug.

Patents can be issued or expire at any time regardless of the drug's approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or neither.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232