How Long Is A Drug Patent Good For?

New Drug Approvals

patent protectionPatents are good for 20 years after the invention of a drug–not after the drug comes to market. It can easily take eight years for the pharmaceutical companies to gather enough data to get approval for their new invention from the U.S. Food and Drug Administration. Meanwhile the FDA can send the drug company back for more clinical studies  (experiments using humans as subjects to test the drugs’ efficacy and side effects) and more data, and all the while the patent clock is ticking.

That’s why the name of the game for pharmaceutical companies is working to extend those patents for a top-selling drug

read all at

How Long Is A Drug Patent Good For? – Drugsdb.com http://www.drugsdb.com/blog/how-long-is-a-drug-patent-good-for.html#ixzz2evb9L5rn

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FDA Grants Forest Drug Combo QIDP Status

New Drug Approvals

Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation from FDA

NEW YORK–(BUSINESS WIRE)–Sept. 12, 2013–Forest Laboratories, Inc. (NYSE:FRX), an international pharmaceutical manufacturer and marketer, today announced that the U.S. Food and Drug Administration (FDA) has designated its investigational drug, ceftazidime/avibactam, a qualified infectious disease product (QIDP). The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act (FDASIA), which was signed into law in 2012. The QIDP designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA’s fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act………

READ ALL AT

http://www.pharmalive.com/fda-grants-forest-drug-combo-qidp-status

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Eisai Co. Ltd. announced that Halaven (eribulin mesylate), an anti-cancer agent, has now been launched in Russia

New Drug Approvals

Eribulin

Eribulin mesylate

Eisai R&D Management Co., Ltd.

13/9/2013

Halaven is a novel anticancer agent discovered and developed in-house by Eisai and is currently approved in more than 50 countries, including Japan, the United States and in Europe. In Russia, Halaven was approved in July 2012 for the treatment of locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens including an anthracycline and a taxane. Approximately 50,000 women in Russia are newly diagnosed with breast cancer each year, with this type of cancer being the leading cause of death in women aged 45 to 55 years. read all at…………………….

http://www.dddmag.com/news/2013/09/eisai-launches-halaven-cancer-drug-russia

Eribulin mesylate (Halaven; Eisai) — a synthetic analogue of the marine natural product halichondrin B that interferes with microtubule dynamics — was approved in November 2010 by the US Food and Drug Administration for the treatment of metastatic breast cancer.

Family members of the product…

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FDA OKs Abraxane With Gemcitabine for Pancreatic Cancer

New Drug Approvals

U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER

-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-

-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-

SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation  (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.  Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

read all at

http://www.pharmalive.com/fda-oks-abraxane-with-gemcitabine-for-pancreatic-cancer

Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles…

View original post 134 more words

FDA OKs Abraxane With Gemcitabine for Pancreatic Cancer

New Drug Approvals

U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER

-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-

-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-

SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation  (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.  Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

read all at

http://www.pharmalive.com/fda-oks-abraxane-with-gemcitabine-for-pancreatic-cancer

Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles…

View original post 134 more words

FDA OKs Abraxane With Gemcitabine for Pancreatic Cancer

New Drug Approvals

U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER

-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-

-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-

SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation  (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.  Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

read all at

http://www.pharmalive.com/fda-oks-abraxane-with-gemcitabine-for-pancreatic-cancer

Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles…

View original post 134 more words

FDA OKs Abraxane With Gemcitabine for Pancreatic Cancer

New Drug Approvals

U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER

-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-

-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-

SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation  (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.  Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

read all at

http://www.pharmalive.com/fda-oks-abraxane-with-gemcitabine-for-pancreatic-cancer

Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles…

View original post 134 more words