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esreddy ☆ 2006-04-28 10:14 (6954 d 23:24 ago) Posting: # 93 Views: 11,613 |
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If a generic got tentatiev approval, after how many days it will goes into market. any information is valuable |
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Helmut ★★★   Vienna, Austria, 2006-04-28 18:58 (6954 d 14:40 ago) @ esreddy Posting: # 94 Views: 9,102 |
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❝ If a generic got tentatiev approval, after how many days it will goes into ❝ market. Hi esreddy, this depends on the country. E.g., in Germany 14 days are not uncommon... — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Essar ● 2006-05-10 13:36 (6942 d 20:02 ago) @ esreddy Posting: # 124 Views: 9,068 |
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❝ If a generic got tentatiev approval, after how many days it will goes into ❝ market. any information is valuable Since you have used the word "ANDA", I will be answering this question with respect to US. If a generic has been granted tentative approval, it could be because that generic applicant has filed a Paragraph III certification: This means that he has agreed that he will market the product only after Innovator's patent has expired. That means as soon as the Innovator's patent expires, this generic applicant can enter the market. This is commonly referred to as Day 1 launch (Day 1 signifying the first day after expiry of Innovator' patent). Regards, Essar |
Ing. Helmut Schütz