Get Indicate Patent Certification

The Indicate Patent Certification is a crucial document for those submitting applications to market new or abbreviated new drugs. This guide will help you navigate the process of filling out this certification effectively, ensuring all necessary information is accurately provided.

Follow the steps to complete the Indicate Patent Certification

1. Click the ‘Get Form’ button to access and open the Indicate Patent Certification form in your browser.
2. Begin by entering the date of submission in the format mm/dd/yyyy. Ensure the date is accurate and reflects when you are submitting the certification.
3. Provide the name of the applicant, including the company or individual's full name in the designated field.
4. Enter the applicable telephone number for the applicant, including the country and area codes.
5. Similarly, fill in the facsimile (FAX) number, including the necessary country and area codes.
6. Complete the applicant address section accurately, ensuring to include street address, city, state, and ZIP or postal code.
7. If applicable, include the name, address, and contact information for the authorized U.S. agent.
8. Fill in the product description fields, such as established name, proprietary name, dosage form, strengths, and route of administration.
9. Indicate if the proposed indication for use pertains to a rare disease and whether it has received FDA orphan designation.
10. Select the appropriate application type (NDA, ANDA, or BLA) and identify if an NDA if applicable.
11. Complete additional sections as required by selecting any relevant submission sub-types and providing reasons for submission.
12. If applicable, fill in the establishment information, including the establishment name and address.
13. Review the certification section and agree to the conditions regarding safety information updates and regulations.
14. After completing the form, digitally sign and date it, ensuring that all signatures are present for the applicant and any authorized agents.
15. Finally, review the entire form for accuracy and completeness before saving changes, downloading, printing, or sharing the form as needed.

Take the next step in your application process by completing the Indicate Patent Certification online today.