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What are the requirements for tigecycline patent extension approval?

See the DrugPatentWatch profile for tigecycline

To obtain a patent extension for a drug like tigecycline, the requirements are typically governed by the regulations outlined in the United States Code Title 35, Section 156. This section of the law provides guidelines for pharmaceutical companies seeking to extend the patent term of their products. The extension is granted to compensate for the time taken during the drug development and regulatory approval process. Specific conditions must be met to qualify for a patent term extension, including the submission of an application to the United States Patent and Trademark Office (USPTO) within certain time frames after obtaining regulatory approval for the drug. The extension can be granted for a period of up to five years, but the total patent term including the extension cannot exceed 14 years from the date of drug approval. It is essential for pharmaceutical companies to adhere to these requirements to secure a patent extension for drugs like tigecycline.

Sources:
- [1] https://www.drugpatentwatch.com/p/tradename/TIGECYCLINE
- [2] https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156
- [3] https://www.drugs.com/availability/generic-tygacil.html


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