FDA generic drug approvals rose in 2023 in bid for improved access
Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
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The Regulatory Maze: How Generic Drugs Navigate FDA Approval
Drug Patent Watch
JULY 24, 2024
In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source
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How to Navigate the Generic Drug Market Post-COVID
Drug Patent Watch
JULY 25, 2024
The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis. As the world continues to recover…
How to find low-competition generic drug opportunities
Drug Patent Watch
JULY 9, 2024
To find low-competition generic drug opportunities, focus on drugs with limited competition due to small patient populations, complex formulations, or […] Source
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Uncovering Lucrative Low-Competition Generic Drug Opportunities
Drug Patent Watch
JUNE 19, 2024
One area that has garnered significant attention is the realm of low-competition generic drugs. These are off-patent medications that, for various reasons, have yet to attract a significant number of generic manufacturers, creating a potential goldmine for […] Source
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How to Develop a Competitive Edge in Generic Drug Development
Drug Patent Watch
JULY 25, 2024
Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market. Here are some key strategies and insights from industry…
Influencers of Generic Drug Utilization
Drug Patent Watch
OCTOBER 16, 2023
In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.
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Innovative Financing Models for Repurposing Generic Drugs
Drug Patent Watch
APRIL 11, 2024
A paper presented at the 2nd International Conference on Systems Medicine, AI, and Drug Repurposing proposes a novel approach to overcoming the financial barriers associated with repurposing generic drugs through… Source
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CpHI Europe: Quality improvements key for the surviving the generic drugs market
Pharmaceutical Technology
OCTOBER 25, 2023
Experts discuss the key trends in quality improvements and API reshoring for the generic drugs market at CpHI Europe.
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Factors that May Predict the Likelihood of Generic Drug Marketing Applications
Drug Patent Watch
OCTOBER 2, 2023
The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.
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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted
STAT News
DECEMBER 2, 2022
The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment.
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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access
STAT News
MARCH 30, 2023
Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.
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Novartis begins plans to spin off generic drug business
Bio Pharma Dive
AUGUST 25, 2022
After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.
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Health Canada disclosing more information on pending generic drug submissions
Pharma in Brief
FEBRUARY 25, 2024
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).
Novartis forecasts improving generic drug business as it weighs unit's future
Bio Pharma Dive
JULY 19, 2022
The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year.
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Finding and Evaluating Generic Drug Market Entry Opportunities
Drug Patent Watch
OCTOBER 6, 2020
Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.
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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review
Drug Patent Watch
OCTOBER 12, 2021
International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.
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Strategies for Pricing Generic Drugs
Drug Patent Watch
JUNE 8, 2021
When it comes to pricing generic drugs, there are a number of factors that come into play. In countries without drug price regulations, the pricing is based largely on profitability.…. The post Strategies for Pricing Generic Drugs appeared first on DrugPatentWatch - Make Better Decisions.
FDA and EMA team up to expedite complex generic drug development
Pharmaceutical Technology
FEBRUARY 8, 2024
This initiative builds on the original parallel scientific advice programme launched by the FDA and EMA in 2021.
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FTC targets middlemen in generic drug shortages probe
pharmaphorum
FEBRUARY 15, 2024
The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines
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Shark Tank's Mark Cuban Dives into Generic Drug Market
BioSpace
JANUARY 14, 2021
Billionaire entrepreneur Mark Cuban, best known as the owner of the Dallas Mavericks and an investor on the ABC business reality series “Shark Tank,” is diving into generic drugs with a new startup, dubbed Mark Cuban Cost Plus Drug Company.
How PBMs and Discount Cards Impact Generic Drug Prices (video)
Drug Channels
JUNE 22, 2022
In the video below, I discuss how generic drug pricing and the rise of patient-paid, discount card prescriptions pose a risk to pharmacy benefit plans and the PBM business. Recently, I explored the complex web of relationships and conflicts that support today’s discount card economics.
Medicare could save up to $3.6 billion by purchasing generic drugs at Mark Cuban prices
Scienmag
JUNE 20, 2022
billion by purchasing generic drugs at Mark Cuban prices Abstract: [link] URL goes live when the embargo lifts A brief research report found that Medicare could have saved up to $3.6 billion by purchasing generic drugs at the same prices as the Mark Cuban Cost Plus Drug […]. Medicare could save up to $3.6
Amazon expands drug subscription program to Medicare members
Bio Pharma Dive
JUNE 20, 2024
RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.
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Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market
Drug Patent Watch
AUGUST 12, 2020
Just because a drug has received FDA approval does not mean that it is available in the marketplace. The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch - Make Better Decisions.
FDA welcomes alternative approaches to generic drug development
The Pharma Data
MAY 5, 2021
FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. FDA webinar on product specific guidance for generic drugs . In FY 2019, 252 were issued, as were 208 in FY 2018. . Source link.
Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs
Pharmaceutical Commerce
JANUARY 23, 2024
Study describes how a game theoretic model can successfully analyze how adoption of blockchain technology can reveal quality information.
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FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters
FDA Law Blog
SEPTEMBER 6, 2023
As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.
Sponsored | China’s Establishing Patent Linkage System More Favorable to Generic Drug Companies o.
BioSpace
NOVEMBER 29, 2020
For the medical industry, China's proposed patent linkage system can be more favorable to generic drug companies than the U.S. The fourth Amendment of the China Patent Law has been deliberated and was passed on October 17, 2020. It will come into force on June 1, 2021.
Global Generic Drugs Market Report 2021: The New Generics Era – The Patent Cliff, Types of Generic Drugs, Simple Generics, Super Generics, Biosimilars, ANDA Approvals – ResearchAndMarkets.com
BioTech 365
MAY 28, 2021
Global Generic Drugs Market Report 2021: The New Generics Era – The Patent Cliff, Types of Generic Drugs, Simple Generics, Super Generics, Biosimilars, ANDA Approvals – ResearchAndMarkets.com Global Generic Drugs Market Report 2021: The New Generics Era – The Patent … Continue reading →
Bloomberg and Drug PatentWatch: A “Perfect Storm” Affecting Generic Drugs
Drug Patent Watch
SEPTEMBER 15, 2020
This likely means fewer generic entrants and less opportunities for consumers to enjoy…. The post Bloomberg and Drug PatentWatch: A “Perfect Storm” Affecting Generic Drugs appeared first on DrugPatentWatch - Make Better Decisions.
GCC Generic Drug Market Trends, Share, Size, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com
BioTech 365
JUNE 25, 2021
GCC Generic Drug Market Trends, Share, Size, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com GCC Generic Drug Market Trends, Share, Size, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “GCC Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast (..)
Sandoz Resolves Legacy Federal Government Civil Investigation in the U.S. Regarding Generic Drugs
BioTech 365
OCTOBER 1, 2021
Regarding Generic Drugs Sandoz Resolves Legacy Federal Government Civil Investigation in the U.S. Regarding Generic Drugs Company previously disclosed settlement agreement in principle and fully provisioned for this resolution Basel, … Continue reading →
Canada Generic Drug Market Industry Trends, Share, Size, Growth, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com
BioTech 365
OCTOBER 4, 2021
Canada Generic Drug Market Industry Trends, Share, Size, Growth, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com Canada Generic Drug Market Industry Trends, Share, Size, Growth, Opportunity and Forecasts 2021-2026 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Canada Generic Drug Market: Industry Trends, (..)
Our Generic Drug Supply Is Sick
NY Times
SEPTEMBER 18, 2021
Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.
Teva to Pay $225M in DOJ Generic Drug Price-Fixing Settlement
BioSpace
AUGUST 21, 2023
Three years after the initial case, Teva Pharmaceuticals is finally settling its drug price-fixing charges with the Department of Justice for $225 million, payable over a five-year period.
AbbVie asks Supreme Court to uphold attorney-client privilege in AndroGel lawsuit
Fierce Pharma
JULY 11, 2024
Supreme Court to overrule a lower court's ruling that the company must turn over records of communications with its lawyers regarding a patent lawsuit it filed against a generic drug maker more than a decade ago.
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Brazil Generic Drug Market (2021 to 2026) – Industry Trends, Share, Size, Growth, Forecast and Opportunities – ResearchAndMarkets.com
BioTech 365
NOVEMBER 18, 2021
Brazil Generic Drug Market (2021 to 2026) – Industry Trends, Share, Size, Growth, Forecast and Opportunities – ResearchAndMarkets.com Brazil Generic Drug Market (2021 to 2026) – Industry Trends, Share, Size, Growth, Forecast and Opportunities – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Brazil Generic (..)
United States Drug Patent Prices Database 2021: Brand vs. Generic Drug Price Gap, find generic entry opportunities – ResearchAndMarkets.com
BioTech 365
APRIL 28, 2021
United States Drug Patent Prices Database 2021: Brand vs. Generic Drug Price Gap, find generic entry opportunities – ResearchAndMarkets.com United States Drug Patent Prices Database 2021: Brand vs. Generic Drug Price Gap, find generic entry opportunities – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The … Continue reading (..)
Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost
Pharmacy Checkers
JULY 11, 2019
I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don’t lead to greater affordability or even access here in the U.S.
Can reforms restore faith in India’s pharma industry after cough syrup scandals?
Pharmaceutical Technology
SEPTEMBER 29, 2023
India is known as the 'pharmacy of the world', producing a substantial quantity of generic drugs globally. However, its lax regulatory oversight has resulted in persistent drug recalls and scandals that have stained the country’s manufacturing reputation.
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Novartis raises drug sales forecast, plans new stock buybacks
Bio Pharma Dive
JULY 18, 2023
The pharma company, which will soon split off its generic drug unit, plans to repurchase up to $15 billion of its shares through the end of 2025.
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Demand Management Solution Helps a Generic Drugs Manufacturer Reduce Costs and Address Supply Chain Complexities | Infiniti’s Recent Client Engagement
BioTech 365
JANUARY 7, 2021
Demand Management Solution Helps a Generic Drugs Manufacturer Reduce Costs and Address Supply Chain Complexities | Infiniti’s Recent Client Engagement Demand Management Solution Helps a Generic Drugs Manufacturer Reduce Costs and Address Supply Chain Complexities | Infiniti’s Recent Client Engagement … Continue reading →
Maximizing ROI with Branded Generics: A Comprehensive Guide
Drug Patent Watch
JUNE 18, 2024
Branded generics are generic drugs that are marketed under a brand name by the manufacturer. Branded generics can be an attractive option for both consumers and pharmaceutical companies, offering cost savings while leveraging brand recognition. […] Source
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