Generic Drug News and Research

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Generic Drugs are official nonbrand names by which medicines are known. Generic names usually refer to the chemical name of the drug.

WHO says governments must do more to improve access to essential medicines

An alarming lack of availability of essential medicines in the public sector drives patients to pay higher prices in the private sector or go without, according to a WHO study reported in the online edition of The Lancet. The results confirm that governments must do more to improve access to essential medicines as part of their efforts to make national health systems more efficient and equitable.

2 Dec 2008

Mylan confirms first-to-file patent challenge of AMRIX capsules

Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules.

1 Dec 2008

Watson Pharmaceuticals receives FDA approval for generic Wellbutrin XL

Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength.

26 Nov 2008

Generic drug competition benefits Ontarians

Following yesterday's release of the Competition Bureau's report, "Benefiting from Generic Drug Competition in Canada: The Way Forward," the Ontario Pharmacists' Association (OPA) is emphasizing that competition in the generic drugs industry is already benefiting Ontarians through accessible, high quality, cost-effective professional pharmacy care.

26 Nov 2008

Barr Labs confirms patent challenge of Amrix extended-release capsules

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.

26 Nov 2008

Teva announces agreement on generic Pulmicort Respules patent challenge

Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva's U.S. generic version of AstraZeneca's Pulmicort (Budesonide) Respules including all claims for patent infringement and damages.

25 Nov 2008

AstraZeneca settles U.S. Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals

AstraZeneca has announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA.

25 Nov 2008

Researchers develop new strategy for broad spectrum anti-viral drugs

Bavituximab, an anti-viral drug developed by UT Southwestern Medical Center researchers, shows promise as a new strategy to fight viral diseases, including potential bioterrorism agents.

24 Nov 2008

Barr announces agreements on Nasacort AQ, Allegra D-12 and Allegra patent challenges

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has entered into separate settlement agreements related to ongoing patent challenges for Nasacort AQ (triamcinolone acetonide) nasal spray, Allegra D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra (fexofenadine) 30mg, 60mg and 180mg tablets.

19 Nov 2008

Mylan receives FDA approval for Fluoxetine capsules

Mylan Inc. has 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 Fluoxetine Capsules USP, 10 mg and 20 mg.

18 Nov 2008

Fitch Ratings revises Merck & Co.'s outlook

Fitch Ratings has affirmed Merck & Co.'s (Merck) ratings, and revised the Rating Outlook to Negative from Stable.

18 Nov 2008

Transition from CFC to HFA asthma inhalers

In less than 3 months, life-saving albuterol inhalers used by nearly 40 million patients with respiratory disorders will no longer be sold.

10 Nov 2008

Mylan receives final approval for generic version of antiepileptic Keppra

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 Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra.

4 Nov 2008

FDA grants tentative approval for 75th generic anti-retroviral drug

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief (PEPFAR).

29 Oct 2008

Malaria medication hydroxychloroquine prevents diabetes in arthritis patients

The use of an antimalarial medication may prevent the onset of diabetes in patients with rheumatoid arthritis, new Geisinger research shows.

28 Oct 2008

Expensive new diabetes drugs don't necessarily produce better outcomes

The annual cost of prescription diabetes drugs nearly doubled to $12.5 billion between 2001 and 2007, according to a study by researchers at the Stanford University School of Medicine and the University of Chicago. The researchers say the findings raise questions about whether the higher cost actually translates into improved care and better outcomes.

28 Oct 2008

Mylan confirms generic Lescol patent challenge

Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

22 Oct 2008

Mylan receives tentative FDA approval for generic versions of Benicar and Uroxatral

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

22 Oct 2008

Barr Laboratories confirms Opana ER tablet patent challenge

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

22 Oct 2008

Teva granted FDA approval for Fentanyl transdermal system

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.

20 Oct 2008