Generics Industry News Search
 |
|
|
|
|
|
|
|
| |
|
The European Union (EU) and India have resumed Free Trade Agreement (FTA) talks, amid claims that the EU is trying force India to accept pharmaceutical patent terms that go beyond world trade agreements.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Solution 1mg/mL (OTC) from the US Food & Drug Administration (USFDA). This approval of Cetirizine Hydrochloride Solution is under over-the-counter (OTC) product category. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application for ibutilide fumarate injection (the generic equivalent of Corvert from Pfizer Inc)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Cephalon Inc. agreed to buy Mepha Gruppe, one of two drugmakers being sold by Germany's Merckle family, to gain generic drugs and double the size of its international business....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis has sold Norgesplaster, its manufacturing facility for plasters and athletic tape and adhesive coating, in Vennesla, Norway, to a newly formed entity Norgesplaster AS. Norgesplaster AS is a legal entity owned by private Norwegian investors. The transaction covers all assets and contracts related to Norgesplaster. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
While many industries are struggling to survive the global financial meltdown, biological and pharmaceutical sectors remain active despite of the change of international economic climate. To many foreign companies, China remains attractive as the world's largest potential market for medical and healthcare services. As biological and pharmaceutical products rely heavily on the protection of intellectual property rights, it's essential for foreign companies in this field to gain thorough understanding of China's IPR protection system before entering this potentially largest market...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Food and Drug Administration has given tentative approval to a generic version of a bone cancer drug, FDA records show....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely laxative...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The government of India has brought into effect stricter norms for obtaining No Objection Certificates (NOCs) for pharmaceutical exporters...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Medicines Co. has filed a case in the U.S. District Court for the Eastern District of Virginia appealing a ruling by the U.S. Patent and Trademark Office and others that denies extension of its patent on a heart drug, according to an 8-K filing with the U.S. and Securities and Exchange Commission....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Watson Pharmaceuticals, Inc., today announced that it has completed the acquisition of Eden Biopharm Group Limited for approximately $15 million. Eden is a biopharmaceutical development and contract manufacturing company located in Liverpool, UK...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread (tenofovir disoproxil fumarate)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The U.S. District Court for the District of Delaware has ruled that Bristol-Myers Squibb may proceed with its patent infringement suit against defendants Mylan Pharmaceuticals Mylan and Matrix Laboratories over Bristol-Myers' patent covering the HIV treatment Sustiva, U.S. Patent No. 6,673,372...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough's brain tumor treatment Temodar (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis today announced the launch of Lercanidipine in five European countries. Lercanidipine is mainly used to treat high blood pressure....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a Nov. 10, 2009, District Court decision that the Company's generic version of Takeda's Prevacid (lansoprazole) SoluTab does not infringe U.S. Patent No. 5,464,632...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Switzerland's Novartis AG said on Friday it was making progress with a generic copy of Sanofi-Aventis SA's blockbuster anti-clotting drug, Lovenox, after an analyst said Novartis was gearing up to launch its version.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Just a few months after closing its $67 billion acquisition of Wyeth Pharmaceuticals, Pfizer Inc. stands ready to spend another $4 billion or so for Germany's leading maker of generic medications, according to news reports...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application to market its generic version of Novartis' breast cancer treatment Femara (letrozole) Tablets, 2.5 mg...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mulls vigil on deals between generic and innovator firms. Indian pharmaceutical companies, which are increasingly choosing to settle patent litigation with global drug majors in the US, would have to be more cautious now...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
United States Food and Drug Administration has revoked the ban imposed on India’s Lupin Ltd's manufacturing facility at Mandideep in Madhya Pradesh, the company announced...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5% prior to the expiration of U.S. Patent No. 5,827,529. Watson's lidocaine topical patch 5% is a generic version of Endo's Lidoderm(R). ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Swedish private equity group EQT will compete with Israeli Teva Pharmaceutical and US major Pfizer Inc to buy German generic drug maker Ratiopharm, German business daily Handelsblatt said today, citing financial sources. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Ranbaxy Laboratories Limited today announced the signing of Agreements with Biovel Lifesciences Private Limited, Bangalore, India, providing for the acquisition of product rights and a manufacturing facility, from Biovel. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5% prior to the expiration of U.S. Patent No. 5,827,529...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Lupin Pharmaceuticals, Inc. announced today that it has received final approval for the Company's Abbreviated New Drug Application for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
San Diego-based Santarus Inc. has sued to block Par Pharmaceutical from releasing a generic version of Zegerid capsules, Santarus' treatment for stomach ulcers....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A loophole in existing law allows manufacturers of brand-name drugs to pay competitors to keep cheaper, generic versions off the market. If there's to be health-care reform this year, it ought to close that loophole...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Cambridge-based biotechnology company Genzyme Corp. is joining in a lawsuit against a generic-drug maker, claiming it is infringing on two patents in its manufacture of a treatment for cholesterol....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL(R) (Colesevelam HCl) tablets, 625 mg. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Hatch-Waxman Act was originally designed to encourage generic drug companies to challenge the patents on name-brand medications, paving the way for cheaper drugs to occasionally enter the market before patents expire. Good, right? But somewhere along the way, the act's initial intent got twisted, leaving us with "pay-for-delay" deals that actually keep cheaper generic drugs off the market. In this arrangement, generics companies that challenge patents held by brand-name drug companies agree to settle by delaying their entry into a market in return for a payment....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Canada's Patented Medicines (Notice of Compliance) Regulations (the "Regulations") have become the de facto means of protecting patented pharmaceuticals in Canada. Some companies list their patents on the Patent Register maintained by the Minister of Health and then wait for a generic challenge...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
GlaxoSmithKline plc (ADR) sees little threat to its top selling drug Advair from generic competition, according to GlaxoSmithKline Chief Executive Andrew Witty....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 250mg, 500mg and 750mg tablets of Levofloxacin, which is used for treatment in a broad spectrum of bacterial infections. Levofloxacin is the generic name for the brand Levaquin, marketed in the United States by Ortho Mcneil (Johnson & Johnson). Wockhardt will launch the product immediately upon expiration of the patent on June 20, 2011. Levofloxacin is a very widely used antibacterial drug and belongs to the fluoroquinolone group. According to IMS, the total market for Levofloxacin tablets in the US is about $1.6 billion....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Patent settlements between drug companies will undergo European Commission scrutiny over concerns some may prevent consumers from obtaining lower-priced medicines...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. today confirmed that it was sued by Cephalon Inc. and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg, 150 mg and 250 mg. Armodafinil Tablets are the generic version of Nuvigil(R) Tablets, which are used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy and shift work sleep disorder. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Pennsylvania has reached a $22.5 million multi-state settlement with Abbott Laboratories, Fournier Industrie et Sante and Laboratories Fournier, S.A., who were accused of blocking competition from generic drug manufacturers.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your company press releases at GenericsWeb, please email us. |
|
|
|
| | |
Home