PIV submission
| 17:02 Dec 4, 2019 |
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| English to Polish translations [PRO] Law/Patents - Medical: Pharmaceuticals | |||||||
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| 3 | wniosek złożony na mocy procedury wynikającej z Paragrafu IV (ustawy Hatch-Waxman Act) |
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| 3 | Podania związane z paragrafem IV |
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| Paragraph IV Certifications List |
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| Discussion entries: 1 | |
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Answers
9 hrs confidence: 
| piv submission wniosek złożony na mocy procedury wynikającej z Paragrafu IV (ustawy Hatch-Waxman Act) Explanation: 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. To seek this approval, a generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) is, in the generic applicant's opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product. This certification is called a "paragraph IV certification." The first company or companies to submit an application that (1) is determined by the agency to be "substantially complete" upon submission and (2) contains a paragraph IV certification to at least one of the patents listed in the Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days. https://www.fda.gov/drugs/abbreviated-new-drug-application-a... cccccccc . Z powyższych 145 wniosków, 73 złożono na mocy procedury wynikającej z Paragrafu IV. Zdaniem Teva, 39 jej wniosków złożono jako pierwsze – wnioski te, twierdzi Teva, odpowiadają rocznej sprzedaży produktów markowych w USA na poziomie ok. 25 miliardów USD. Jeśli Teva była pierwszą spółką, która złożyła takie certyfikaty na mocy Paragrafu IV, przysługuje jej do 180 dni wyłączności na wprowadzanie produktów na rynek. https://www.bankier.pl/static/att/emitent/2005-11/Quarterly_... |
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11 hrs confidence:
| piv submission Podania związane z paragrafem IV Explanation: To możę być to, że oni śledzą każde podanie wpływające do FDA lub sami je składają |
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Reference comments
7 hrs peer agreement (net): +1 |
| Reference: Paragraph IV Certifications List Reference information: As part of its ongoing efforts to assist generic drug applicants in preparing their applications, the Food and Drug Administration (FDA or the Agency) regularly publishes information relevant to 180-day exclusivity for generic drug applicants provided under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Generally, this list describes drug products for which one or more substantially complete abbreviated new drug applications (ANDAs) containing a “paragraph IV” (PIV) patent certification have been submitted to FDA. (For more information on 180-day exclusivity, see FDA’s draft guidance for industry on 180-Day Exclusivity: Questions and Answers (Jan. 2017).) Historically, this list has included the name of the drug product, dosage form, strength(s), reference listed drug (RLD)/new drug application (NDA) number, and, beginning on March 2, 2004, the date on which the first substantially complete ANDA(s) (or amendment or supplement to one) was submitted to the Agency that contained a paragraph IV certification. - https://www.fda.gov/drugs/abbreviated-new-drug-application-a... |
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