Generics

Alzheimer generic launched in the US

Generics/News | Posted 28/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).

Generic Parkinson’s drug hits US market

Generics/News | Posted 21/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.

ANI Pharmaceuticals acquires 22 generics from Teva

Generics/News | Posted 14/08/2015

US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 13 July 2015 that it had acquired 22 previously marketed generics from Teva Pharmaceutical Industries (Teva).

Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world

Generics/Research | Posted 07/08/2015

Essential cancer and supportive drug shortage in the US seriously affects cancer care, and increases cost pressure on the health system. These drugs are mostly off-patent generics. Collaborative efforts of FDA, pharmacists, physicians and pharmaceutical companies slightly improve this problem. However, these measures are partial. For an issue of multiple complexities there is no single magic stick that could solve it. The underlying economic issues and lack of incentives for production need to be addressed to arrive at innovative and permanent solutions for this multifactorial problem [1, 2].

Generic bivalirudin approved in US

Generics/News | Posted 07/08/2015

US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).

Effect of price caps and reference pricing on generics entry

Generics/Research | Posted 31/07/2015

In a study carried out by Brekke and co-authors on the impact of price caps in combination with reference pricing on generics entry was investigated [1].

Actavis hit with lawsuit over generic version of weight-loss drug

Generics/News | Posted 31/07/2015

US-based obesity specialist Orexigen Therapeutics (Orexigen) and its North American partner, Takeda Pharmaceuticals (Takeda), have sued Actavis (Allergan’s US generics business) over its generic version of the weight-loss drug Contrave (naltrexone/bupropion).

Effect of co-insurance and reference pricing on generics entry

Generics/Research | Posted 03/07/2015

To study the impact of reference pricing on generics entry Brekke and co-authors developed a novel Salop-type model where a brand-name producer competes with several generics makers in terms of prices [1].

Indian pharma industry to get government support

Generics/General | Posted 03/07/2015

In a bid to promote the manufacture of pharmaceuticals in the country, the Indian Government has announced plans to set up a Rs 500-crore venture capital fund to provide cheaper loans to firms looking to establish or upgrade manufacturing facilities.

Mylan launches generic asthma inhaler in UK

Generics/News | Posted 03/07/2015

US generics manufacturer Mylan announced on 8 June 2015 that it had launched the first bioequivalent alternative to GlaxoSmithKline (GSK)’s asthma inhaler Seretide/Advair (fluticasone/salmeterol) in the UK.

Effect of reference pricing on generics entry

Generics/Research | Posted 26/06/2015

Reference pricing can produce substantial savings, but what conditions are the most likely to result in cost savings? This was a question addressed by Brekke and co-authors from the University of Minho in Portugal in their Working Paper [1].

Generics of ADHD drug launched in US

Generics/News | Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

Malaysian physicians have negative perceptions of generics

Generics/Research | Posted 12/06/2015

A study investigating the knowledge, perceptions and behaviour of physicians from private medical centres in Malaysia regarding generics found that the majority of physicians had negative perceptions about the safety, quality and efficacy of generics [1].

Osteoporosis and ADHD generics launched in USA

Generics/News | Posted 12/06/2015

On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.

Drug evergreening strategies in India

Generics/Research | Posted 05/06/2015

A study of drug patent evergreening in India found that this is a strategy that has been used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents. It is also a strategy still being used in India despite the efforts of Section 3(d) of the Indian Patent Act to curb such practices [1].

Generics applications under review by EMA – April 2015

Generics/General | Posted 05/06/2015

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

FDA receives application for first generic of HIV drug dolutegravir

Generics/News | Posted 05/06/2015

India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).

Physicians’ perceptions of HIV generics in France

Generics/Research | Posted 29/05/2015

A study of French physicians in HIV clinics found that, while the majority of these physicians were willing to prescribe antiretroviral generics, a quarter of physicians were openly opposed to antiretroviral generics [1].

Patients’ perceptions of HIV generics in France

Generics/Research | Posted 22/05/2015

In a study of patient perceptions of HIV generics in France, Jacomet and co-authors found that while the majority of patients accepted antiretroviral generics, a third of the patients were openly opposed to antiretroviral generics [1].

Generics of high blood pressure medication launched

Generics/News | Posted 22/05/2015

On 31 March 2015, generics majors Mylan, Sandoz and Teva Pharmaceutical Industries (Teva) announced the US launch of their respective generic amlodipine and valsartan combination tablets in four dosages.

Patients’ and physicians’ perceptions of HIV generics

Generics/Research | Posted 15/05/2015

A study of adult HIV positive outpatients and their physicians in clinics across France found that a third of patients and a quarter of physicians are openly opposed to antiretroviral generics [1].

TWi and Takeda settle dispute over anti-reflux generic

Generics/News | Posted 15/05/2015

Taiwan-based TWi Pharmaceuticals (TWi) announced on 27 April 2015 that it had entered into a settlement agreement with Takeda Pharmaceutical Company, Takeda Pharmaceuticals USA and Takeda Pharmaceuticals America (Takeda) to settle and dismiss all outstanding patent litigation related to TWi’s generic dexlansoprazole.

Statin generics improves adherence

Generics/Research | Posted 08/05/2015

Switching from a brand-name statin to a generic statin has been shown to improve adherence, researchers in Sweden report [1].

FDA approves first generics of antipsychotic drug

Generics/News | Posted 04/05/2015

The US Food and Drug Administration (FDA) announced on 28 April 2015 the approval of the first generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole).

Poland’s experience with generic imatinib

Generics/Research | Posted 27/04/2015

In July 2014, Poland became the first country in the European Union (EU) to introduce a generic form of the chronic myeloid leukaemia (CML) treatment imatinib. This, and the dearth of reliable information related to CML patients in Europe who have taken generic imatinib, make the country uniquely positioned to monitor the process of switching from the brand-name drug to its generic, according to author Patrycja Rusicka of the Medical University of Warsaw, Poland [1].

Soaring generics prices come under increased scrutiny

Generics/General | Posted 27/04/2015

The US Department of Health and Human Services (HHS) is to investigate the soaring prices of generics in the US.

Safety and cost considerations of generic and originator gabapentin

Generics/Research | Posted 17/04/2015

The launch of generic garbapentin prompted researchers from the Chulalongkorn University and the King Chulalongkorn Memorial Hospital in Bangkok, Thailand, to carry out a study to compare the safety and effectiveness of generic gabapentin compared to originator gabapentin (Neurontin) [1].

IDT Australia gets FDA nod for 23 generics

Generics/News | Posted 17/04/2015

IDT Australia announced on 13 April 2015 that the US Food and Drug Administration (FDA) had accepted the transfer of ownership of 23 generics to the Australia-based company.

Brazilian patients positive about generics

Generics/Research | Posted 10/04/2015

A study looking at patients perceptions on generics in Brazil concludes that, although Brazilian patients have a positive attitude towards generics, more work is needed to increase the use of generics in the country.

Effectiveness of generic and originator gabapentin in lower back pain

Generics/Research | Posted 10/04/2015

Researchers from the Chulalongkorn University and the King Chulalongkorn Memorial Hospital in Bangkok, Thailand, carried out a study to compare the effectiveness of generic gabapentin Sandoz compared to originator gabapentin (Neurontin) [1].

France outlines plans to promote generics

Generics/General | Posted 10/04/2015

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, in 2012, in order to combat rising healthcare costs, the French Government introduced measures to increase generic drug use in the country [1]. Now the government has gone a step further and is introducing a national action plan to encourage the use of generics in the country.

Comparison of generic and originator gabapentin

Generics/Research | Posted 03/04/2015

The cost of treatment for patients with neuropathic lower back pain is higher than those with non-neuropathic lower back pain. Originator gabapentin (Neurontin), an anticonvulsant, the efficacy has been proven for pain improvement among patients with neuropathic pain. In Thailand, gabapentin has usually been prescribed for patients having chronic back pain associated with lumbar radiculopathy, however, the high cost of originator gabapentin (Neurontin) has been found to be a problem for patients. Although generic gabapentin has recently been launched in Thailand, there is limited clinical evidence to prove its effectiveness compared to the originator.

Shire grabs Par’s attention with patent lawsuit

Generics/News | Posted 03/04/2015

Shire has served its rival Par Pharmaceutical (Par) with a patent infringement lawsuit in New Jersey Federal Court over Par's application to market a generic version of Shire's attention deficit hyperactivity disorder medication Adderall XR.

Dr Reddy’s US drug pricing comes under scrutiny

Generics/General | Posted 03/04/2015

Dr Reddy’s Laboratories, the India-based generics drugmaker, has been asked to share drug-pricing information with the attorneys general of California and Texas in November 2014. The two US States take their lead from an investigation into generics pricing at the national level.

Generics utilization policies necessary to sustain Medicaid

Generics/Research | Posted 27/03/2015

A review of the history and expansion of generics utilization policies and their critical role in the US Medicaid system in an era of reduced budgets concluded that such policies are a necessary component for preservation of the Medicaid system [1].

Actavis loses Atelvia patents

Generics/News | Posted 27/03/2015

Teva Pharmaceutical Industries (Teva) has won a legal battle against Actavis after a federal judge invalidated two patents protecting the post-menopausal osteoporosis drug Atelvia (risedronate sodium delayed-release tablets, 35 mg). Actavis acquired Atelvia in 2013 when it bought Irish drugmaker Warner Chilcott [1], which continues to produce the drug as an Actavis subsidiary.