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Next Page Export Data Import Data Reset Form Form Approved: OMB No. 0910-0338 Expiration Date: December 31, 2013 See PRA Statement on page 3. 1. Date of Submission (mm/dd/yyyy) APPLICATION TO MARKET.

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Paragraph IV Patent Certifications. Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

Paragraph IV Patent Certifications. Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

A Paragraph III certification is an ANDA filer's statement that it will not market its bioequivalent product until after the expiration of a patent listed as covering that product.

Paragraph III Certification means a certification that a generic applicant seeks FDA approval of its ANDA as of the date a patent listed in the Orange Book for a relevant NDA expires.

Paragraph I certification means a certification that a generic applicant seeks FDA approval of its ANDA for a relevant NDA for which no patent information has been filed in the Orange Book.

A paragraph IV filing is a subset of an ANDA application, where the generic applicant is claiming that the patent they are targeting is unenforceable either due to i) invalid or, ii) not infringed or iii) both invalid and non infringed by their product. FTF(First To File) & 180 Days Exclusivity.

A patent certificate is a certified copy of an approved patent application provided by the United States Patent and Trademark Office (USPTO). Having patent protection allows you to legally prevent others from making, using, marketing, or selling your invention.

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Book is that it has an NDA or abbreviated new drug application (ANDA) that has been approved and that has not been withdrawn for safety or effectiveness reasons or determined by FDA to have been withdrawn for safety or effectiveness reasons.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
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
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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