Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Drug Patent Watch

MARCH 12, 2025

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. 11 Must-know FAQs about the Drug Approval Process in Japan. Freyr Solutions.

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Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drug development?

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Drug Patent Watch

SEPTEMBER 10, 2024

The generic drug market has experienced significant growth over the past few decades, driven by the passage of the Hatch-Waxman Act in 1984 and subsequent legislation. Today, the market is more competitive than ever, with generic drugs accounting for over 90% of all prescriptions in the United States.

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Drug Patent Watch

SEPTEMBER 19, 2024

The generic drug market in the United States is characterized by significant price volatility and shortages, driven by the structure of the market and the incentives for manufacturers. To address these issues, several market-based proposals have been put forth to optimize generic drug cost and availability.

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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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Drug Patent Watch

SEPTEMBER 23, 2024

The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.

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Drug Patent Watch

SEPTEMBER 30, 2024

Patent expirations have a significant impact on the pharmaceutical industry, particularly on the generic drug market. When a drug’s patent expires, other manufacturers can produce and market generic versions of the drug, leading to increased competition and lower prices.

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Drug Patent Watch

SEPTEMBER 11, 2024

This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients. One of the most promising applications of nanotechnology is in generic drug development, where it offers unparalleled opportunities to enhance efficacy, safety… Source

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Patent Watch

JANUARY 22, 2025

The Unseen Journey of Generic Drugs: A Look into the Regulatory Pathway Have you ever wondered how generic drugs make it to the market? As a healthcare professional or a pharmaceutical enthusiast, understanding the pathway to generic drug approval can be fascinating. But what happens when the patent expires?

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Drug Patent Watch

AUGUST 27, 2024

The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of advanced manufacturing technologies (AMTs). These innovations aim to enhance drug quality, efficiency, and customization.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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STAT News

MARCH 3, 2023

” Cipla, which is one of the world’s largest generic drug manufacturers, was recently cited by inspectors from the U.S. Food and Drug Administration for a litany of violations at a plant in India.

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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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Pharmaceutical Technology

SEPTEMBER 15, 2022

increase in revenue from 2020 to 2021 from sales of Revlimid, its multiple myeloma therapy, with a global analyst consensus sales forecast of $12.8bn for 2021, according to GlobalData’s Drugs Database. However, other challenges facing biopharmaceutical companies include growing generic drug competition, which places pressure on drug prices.

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Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage.

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STAT News

AUGUST 22, 2022

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S.

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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.

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Drug Patent Watch

SEPTEMBER 25, 2024

Generic drug manufacturers face significant challenges when attempting to navigate around REMS (Risk Evaluation and Mitigation Strategies) imposed by brand-name drug companies. These strategies, intended to ensure drug safety, are sometimes misused to delay generic competition.

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World of DTC Marketing

APRIL 12, 2021

The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages.

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Pharmacy Checkers

MAY 22, 2020

One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. has the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19.

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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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STAT News

AUGUST 3, 2022

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S.

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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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 →

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BioTech 365

FEBRUARY 3, 2021

This New Year, SMB Generic Drug Manufacturers Take Back Control with MDH Insight’s Trailblazing EmpowerRM® Pharma Chargeback Software This New Year, SMB Generic Drug Manufacturers Take Back Control with MDH Insight’s Trailblazing EmpowerRM® Pharma Chargeback Software PEMBROKE PINES, Fla.–(BUSINESS

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Drug Patent Watch

AUGUST 20, 2024

Digital twins are revolutionizing the pharmaceutical and biopharmaceutical industries by integrating physical plants, data collection, data analysis, and system control. […] Source

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BioSpace

AUGUST 29, 2023

Lupin Pharmaceuticals' recall of Tydemy birth control is the latest in a string of problems with India-based generic drug manufacturers.

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. FAQs Q: What is the difference between a biosimilar and a generic drug?

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

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FDA Law Blog

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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pharmaphorum

JUNE 6, 2022

The costs associated with the supply chain, rather than solely the cost of making the drug, raise the end price of medications, which are then passed onto consumers. MCCPDC’s site says it can lower prices by directly opening the pathway from manufacturers to consumers, decreasing medicine costs by cutting unnecessary expenses.

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