Azithromycin patent expiration date

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That, of course, piques our interest; and it leads to research so that we can get clarification. Section 4 b 1 of the QI Act includes three transition provisions: The first applicant fails to azithromycin patent tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which expiration date application is filed. The statute does not specifically reference the date does weed make adderall stronger the submission of a Paragraph IV certification. That opens the possibility that an ANDA applicant could simultaneously qualify and expiration date eligibility for day exclusivity see our previous post here. This exclusivity, patent expiration azithromycin is provided expiration date under section j 5 B iv of the Act, would begin to run from the date of the commercial marketing identified in section j "date" B iv. It will do so only if a subsequent paragraph IV applicant becomes eligible for full approval a within days after Lupin begins commercial marketing of Azithromycin for Oral Suspension USP. As of the month forfeiture date i. But there was a saving grace "azithromycin patent" there for Lupin. The Agency will make every effort to ensure the accuracy of the information disclosed in this list.

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This is a continuation of application Ser. The present invention is directed to a valuable new form of azithromycin 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A , viz. Azithromycin is the U. Azithromycin was independently discovered by Bright, U. As previously crystallized from ethanol and water e. Because of its hygroscopic nature, it is most difficult to prepare and maintain this prior monohydrate product in a form having a constant, reproducible water-content. It is particularly difficult to handle during formulation, since at higher relative humidity levels which are generally required to avoid electrostatic problems e.

azithromycin patent expiration date

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