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.

India's patent office rejects Boehringer's application for pediatric antiretroviral

India's Patent Office in New Delhi earlier this month rejected German drug maker Boehringer Ingelheim's application for a pediatric version of the antiretroviral drug nevirapine, consequently allowing local generic pharmaceutical companies such as Aurobindo and Cipla to continue marketing low-cost versions of the medicine in the domestic market, the Business Standard reports.

24 Jun 2008

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Barr Laboratories, Inc. has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin (drospirenone and ethinyl estradiol) and Yaz (drospirenone and ethinyl estradiol) oral contraceptive products.

24 Jun 2008

Study shows generics now own 63% of Medicare Part D market

Wolters Kluwer Health, a division of Wolters Kluwer, has released the results of a study that looks at key statistical outcomes of the Medicare Part D (MPD) prescription drug program.

23 Jun 2008

Ranbaxy and Pfizer settle on Lipitor patent litigation

Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world's most-prescribed cholesterol-lowering medicine.

19 Jun 2008

Wall Street Journal examines efforts to encourage adoption of electronic prescribing technology

The Wall Street Journal on Tuesday examined several factors that are pushing physicians to adopt electronic prescribing technology, reporting that while the "possible benefits to doctors and patients are clear," there are obstacles that "hinder widespread adoption." Fewer than 10%, or about 35,000, of U.S. physicians currently use e-prescribing technology.

17 Jun 2008

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Pharmaceutical companies, which "have been waging war against inexpensive generic drugs for years at the national level," are now "taking their fights to the states, promoting proposals that would" bar pharmacists from automatically replacing prescriptions for brand-name drugs with generics, the Baltimore Sun reports.

17 Jun 2008

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

16 Jun 2008

Mylan wins generic Prilosec patent litigation

Mylan Inc. has announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 2007 District Court ruling stating that Mylan's 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe patents asserted against Mylan by AstraZeneca.

11 Jun 2008

Barr confirms patent challenge of Prevacid SoluTab tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

11 Jun 2008

Obama launches economic tour, promotes health care proposal

Presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) on Monday began a two-week economic tour in Raleigh, N.C., where he discussed his proposals to address the economy, health care and other issues, the AP/Philadelphia Daily News reports (Babington, AP/Philadelphia Daily News, 6/10).

11 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

Walgreen agrees to pay $35 million to settle allegations of improper medication switches for Medicaid beneficiaries

Walgreen has agreed to pay $35 million to settle allegations that the company improperly switched the form of generic medications prescribed to Medicaid beneficiaries to receive higher reimbursements from the program, the Hartford Courant reports (Levick, Hartford Courant, 6/5).

8 Jun 2008

FDA grants pediatric exclusivity for UCB's Keppra

UCB has announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

8 Jun 2008

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

In a national survey released today by the Alliance of Minority Medical Associations (AMMA), Americans noted that their highest health care priority is reducing the cost of prescription drugs. Furthermore, survey respondents shared overwhelming support for creating an approval pathway for generic, or follow-on biotechnology therapies, with 86% of likely voters stating their desire for such a system.

4 Jun 2008

Mylan confirms Azor patent challenge

Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor Tablets.

4 Jun 2008

Cephalon files patent infringement case against Watson Pharmaceuticals

Cephalon, Inc. today announced that it and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in U.S. District Court in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal tablet) [C-II].

3 Jun 2008

Mylan acquires generics businesses of Merck KGaA

Mylan Inc. today announced that it has acquired Merck KGaA's Central & Eastern Europe (CEE) generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic.

2 Jun 2008

Watson receives approval of Omeprazole delayed-release capsules

Watson Pharmaceuticals, Inc. has announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.

2 Jun 2008

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Brand-name prescription drug makers in fiscal year 2007 reached 14 agreements with generic drug makers to delay market entry of generic medications, according to a report released on Wednesday by the Federal Trade Commission, Reuters reports (Bartz, Reuters, 5/23).

28 May 2008

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

Officials from pharmacy benefit manager Express Scripts on Tuesday said the company has agreed to pay $9.5 million to settle lawsuits brought by 28 states and Washington, D.C., alleging it defrauded the states and D.C., the AP/Denver Post reports.

28 May 2008

Generic Drug News and Research

Further Reading

India's patent office rejects Boehringer's application for pediatric antiretroviral

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Study shows generics now own 63% of Medicare Part D market

Ranbaxy and Pfizer settle on Lipitor patent litigation

Wall Street Journal examines efforts to encourage adoption of electronic prescribing technology

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Mylan wins generic Prilosec patent litigation

Barr confirms patent challenge of Prevacid SoluTab tablets

Obama launches economic tour, promotes health care proposal

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Walgreen agrees to pay $35 million to settle allegations of improper medication switches for Medicaid beneficiaries

FDA grants pediatric exclusivity for UCB's Keppra

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

Mylan confirms Azor patent challenge

Cephalon files patent infringement case against Watson Pharmaceuticals

Mylan acquires generics businesses of Merck KGaA

Watson receives approval of Omeprazole delayed-release capsules

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

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