scholarly journals The trend in patent infringement litigation against generic drugs or biosimilars in Japan

2019 ◽  
Vol 15 (1) ◽  
pp. 10-17
Author(s):  
Sachiko Masuda
Keyword(s):  
Drug Use ◽  
Market Entry ◽  
Generic Drugs ◽  
Patent Infringement ◽  
Brand Name ◽  
Market Environment ◽  
Institutional Reforms ◽  
Drug Companies ◽  
Emerging Issues ◽  
Legislative Changes

The timing of market entry for generic drugs or biosimilars based on patent expiration is not always clear for producers of generic drugs and biosimilars or brand-name drug companies, because of an uncertainty due to patent infringement, the market environment, and legislation. In Japan, the policy of promoting the use of generic drugs began in the early 2000s, and the government’s target for generic drug use rate is 80% by 2020. In addition to this drastic change in the market environment, changes in legislation have complicated the timing of market entry for generic drugs and biosimilars. Although there is a relatively low number of patent infringement lawsuits filed against producers of generic drugs and biosimilars each year, emerging litigation issues are likely influenced by recent changes in the market environment and legislation. This article provides an overview of recent legislative changes, analyzes the trends in patent infringement litigation, and discusses litigation issues related to the stable supply of generic drugs and biosimilars in Japan. In light of the emerging issues in this field, producers of generic drugs and biosimilars will require more diligence to avoid patent infringement, and institutional reforms are suggested to reduce an increase in patent infringement litigation.

Recent Developments in Health Law

2012 ◽  
Vol 40 (1) ◽  
pp. 165-170
Author(s):  
Brenna Jenny
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Tort Law ◽  
Drug Manufacturer ◽  
Recent Change ◽  
Brand Name ◽  
Drug Companies ◽  
Drug Regulations ◽  
Recent Developments ◽  
The Individual

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.

scholarly journals A Review of Clinical Studies of Brand-name and Generic Drugs Used in Arrhythmia

2016 ◽  
Vol 25 (4) ◽  
pp. 417-429
Author(s):  
Kaoru Ito ◽  
Shunya Ikeda ◽  
Masaki Muto
Keyword(s):  
Clinical Studies ◽  
Generic Drugs ◽  
Brand Name

scholarly journals Cost Minimisation Study of the Impact of Generic Drugs on Glaucoma Management: 1-year Indian Experience

1970 ◽  
Vol 12 (4) ◽  
pp. 192-196
Author(s):  
Devindra Sood ◽  
Alka Pandey ◽  
Rajeev Sood ◽  
Nagesh Gupta ◽  
Ravinder Kumar Bajaj ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Open Angle Glaucoma ◽  
Eye Drops ◽  
Brand Name ◽  
Cost Difference ◽  
Medication Costs ◽  
Generic Medications ◽  
The Mean ◽  
The Cost ◽  
The Impact

Aim: To study the medication costs of various topical glaucoma medications using data collected from real world use by patients.Methods: Patients with primary open angle glaucoma treated at glaucoma clinics in 5 hospitals (1 rural and 4 urban) in northern India from 1 January to 30 June 2008 were enrolled. The number of days each bottle of medication lasted was recorded, and the mean cost per day was computed from the maximum retail price and mean number of days each medication lasted.Results: 790 of 801 eligible patients completed the study. The mean number of days that a bottle of medication lasted was found to be highest for Xalatan® and Xalacom® at 35.23 days and 35.00 days, respectively. The brand name prostaglandin analogues all lasted for a mean of more than 30 days: Xalatan, 35.23 days (SD, 4.14 days); Lumigan®, 31.37 days (SD, 5.31 days); and Travatan®, 34.84 days (SD, 6.51 days), while the generic eye drops lasted for about 21 days: latanoprost, 20.69 days (SD, 3.69 days) and bimatoprost, 21.39 days (SD, 4.34 days). The cost of the generic medication was less than the brand name medication in all groups (for example, bimatoprost, Indian rupees 9.76 versus Indian rupees 12.33) except for brimonidine/timolol (Indian rupees 8.73 versus Indian rupees 8.66). Further analysis in 2009 showed that, for latanoprost, brimonidine and brimonidine/timolol, the difference between the brand name and generic medications decreased in 2009 over 2008 (in the latanoprost group, the cost difference over the year reduced from Indian rupees 592 in 2008 to Indian rupees 523 in 2009); the cost difference for bimatoprost increased from 2008 to 2009.Conclusion: When both cost and number of days a bottle lasts were considered over the long term, use of generic medications might not minimise the cost of glaucoma medical management by much when compared with the brand name medication.

scholarly journals Can income-based co-payment rates improve disparity? The case of the choice between brand-name and generic drugs

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Yuki Ito ◽  
Konan Hara ◽  
Byung-Kwang Yoo ◽  
Jun Tomio ◽  
Yasuki Kobayashi
Keyword(s):  
Generic Drugs ◽  
Income Group ◽  
High Income ◽  
Medical Expenditure ◽  
High Income Group ◽  
Brand Name ◽  
Income Groups ◽  
Additional Payment ◽  
Brand Name Drugs ◽  
Payment Rate

Abstract Background Higher income population tend to prefer brand-name to generic drugs, which may cause disparity in access to brand-name drugs among income groups. A potential policy that can resolve such disparity is imposing a greater co-payment rate on high-income enrollees. However, the effects of such policy are unknown. We examined how patients’ choice between brand-name and generic drugs are affected by the unique income-based co-payment rates in Japan; 10% for general enrollees and 30% for those with high income among the elderly aged 75 and over. Methods We drew on cross-sectional price variation among commonly prescribed 311 drugs using health insurance claims data from a large prefecture in Japan between October 2013 and September 2014 to identify between-income-group differences in responses to differentiated payments. Results Running 311 multivariate logistic regression models controlling individual demographics, the median estimate indicated that high-income group was 3% (odds ratio = 0.97) less likely to choose a generic drug than the general-income group and the interquartile estimates ranged 0.92–1.02. The multivariate feasible generalized least squares model indicated high-income group’s higher likelihood to choose brand-name drugs than the general-income group without co-payment rate differentiation (p < 0.001). Such gap in the likelihood was attenuated by 0.4% (p = 0.027) with an US$1 increase in the difference in additional payment/month for brand-name drugs between income groups — no gap with US$10 additional payment/month. This attenuation was observed in drugs for chronic diseases only, not for acute diseases. Conclusions Income-based co-payment rates appeared to reduce disparity in access to brand-name drugs across income groups, in addition to reducing total medical expenditure among high-income group who shifted from brand-name drugs to generic ones due to larger drug price differences.

scholarly journals Comparison of the Properties of Brand-Name and Generic Nadifloxacin Creams

Medicina ◽  
2011 ◽  
Vol 47 (11) ◽  
pp. 89
Author(s):  
Yutaka Inoue ◽  
Miruto Matsumoto ◽  
Masayuki Kimura ◽  
Toru Tanaka ◽  
Ikuo Kanamoto
Keyword(s):  
Water Content ◽  
Absorption Spectroscopy ◽  
Infrared Absorption ◽  
Near Infrared ◽  
Generic Drugs ◽  
Infrared Absorption Spectroscopy ◽  
Brand Name ◽  
Yield Value ◽  
Lower Viscosity ◽  
Brand Name Drugs

Background and Objective. In external preparations, types and ratios of additives are not necessarily the same for brand-name drugs and generic drugs. Thus, the physicochemical properties of preparations may differ despite the fact that they contain the same ingredients or additives. This study examined differences in brand-name and generic versions of nadifloxacin (NFX) creams. Material and Methods. Three types of NFX creams (NFX-A, NFX-B, and NFX-C) were used. The viscosity of each preparation was determined, its yield value was calculated, and each preparation was subjected to light microscopy, x-ray powder diffraction, and near-infrared absorption spectroscopy. Results. Comparison of viscosity of different preparations revealed that NFX-B had a lower viscosity than NFX-A and NFX-C (14.5 vs. 24.6 and 17.9 Pa·s). NFX-B also had a lower yield value than NFX-A and NFX-C. Microscopy revealed that NFX-A and NFX-B had satisfactory emulsification although crystallization was observed with NFX-C. Near-infrared absorption spectroscopy revealed changes in the absorption spectra of NFX-B in comparison with those of NFX-A and NFX-C that were due to differences in water content and differences in fat and oil content. Conclusions. These findings confirmed that there were differences in the viscosity and flattening of NFX-A, NFX-B, and NFX-C. In addition, microscopy revealed differences in emulsification and it revealed the precipitation of NFX crystals in NFX-C. Near-infrared absorption spectroscopy revealed that differences in the type and amount of additives and water content in the creams had contributed to differences in the preparations.

scholarly journals DRUG UTILISATION STUDY OF STROKE AND OTHER PATIENTS ADMITTED TO GENERAL WARD OF NEUROLOGY UNIT AT QUATERNARY CARE PRIVATE HOSPITAL

2017 ◽  
Vol 9 (4) ◽  
pp. 23
Author(s):  
Laxman Wagle ◽  
Abel Abraham Thomas ◽  
Sunil Shrestha
Keyword(s):  
Drug Use ◽  
Prospective Observational Study ◽  
Private Hospital ◽  
Drug Utilisation ◽  
Generic Drugs ◽  
General Ward ◽  
Microsoft Excel ◽  
Use Patterns ◽  
Drug Classes ◽  
Drug Use Patterns

Objective: To study the profile of the patient, the pattern of their illness and their drug use patterns attending to general ward of quaternary care hospital.Methods: Prospective observational study of 2 mo was performed at neurology unit of the quaternary care private hospital, India. Patients aged above 20 y with at least one neurological drug in prescription were included to observe their demographic profile, illness pattern and drug use. The data was analysed and summarised as frequency and percentage using microsoft excel and presented as tables.Results: Among 60 patient that were enrolled, more were males (N=33, 55%) than females (N=27, 45%) and within the age group of 60-70 y (N=22, 36.67%). The majority of patients were diagnosed with strokes (N= 48, 80%) where the cerebrovascular accident was most common (N=16, 26.66%). Males (N=29, 60.4%) were more prone to get stroke than females (N=19,39.6%). An average number of drugs per prescription was 5.7, the percentage of antibiotics, generic drugs and injections were 36.6%, 0.05% and 44.14% respectively. A total of 28 different drug classes with 61 different drugs was utilised. Fourteen drug classes had been accounted for 90% of drugs utilisation. Clopidegrol+Aspirin have frequently used the drug.Conclusion: Most people attending neurology unit were elderly. Stroke occupies 1st list for the burden. Average drugs for neurology visit remain high. Wide types of drug classes are utilised in neurological wards

Taste acceptability of pulverized brand-name and generic drugs containing amlodipine or candesartan

2016 ◽  
Vol 511 (2) ◽  
pp. 1136-1137
Author(s):  
Sebastiano A.G. Lava ◽  
Maristella Santi ◽  
Mario G. Bianchetti
Keyword(s):  
Generic Drugs ◽  
Brand Name
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