Drug Patent Watch

OCTOBER 24, 2024

The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. Food and Drug Administration… Source

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Drug Patent Watch

APRIL 8, 2025

Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts.

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Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage.

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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. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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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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Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

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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 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 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 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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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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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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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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Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.

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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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Drug Patent Watch

DECEMBER 9, 2024

This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents? This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?

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Pharmaceutical Technology

SEPTEMBER 15, 2022

BioNTech has shifted its focus towards oncology, with the company expecting the first results from a Phase II trial of its first-in-class CAR-T drug, BNT211, for multiple solid tumours. However, other challenges facing biopharmaceutical companies include growing generic drug competition, which places pressure on drug prices.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year.

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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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Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.

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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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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy.

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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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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Pharmaceutical Technology

DECEMBER 15, 2022

Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. In June, generic drug manufacturing giants wrote to the EU to request help with rising costs so that their products remain viable.

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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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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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pharmaphorum

JUNE 6, 2022

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . “Manufacturers get a bad rap as being the source of high pricing for patient meds.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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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

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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FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. 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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