Finding and Evaluating Generic Drug Market Entry Opportunities

Drug Patent Watch

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….

Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market

Drug Patent Watch

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.

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Bloomberg and Drug PatentWatch: A “Perfect Storm” Affecting Generic Drugs

Drug Patent Watch

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.

Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

Pharmacy Checkers

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. The KHN article concluded that the lack to generic availability in the U.S. generic for 3 of the drugs.

Novateur Ventures: Overlooked Generic Drug Strategy May Prevent COVID-19’s Cytokine Storm


Two generic anti-inflammatory drugs typically used in asthma treatments are being proposed for use with COVID-19 because of their potential to dampen disease progression and severity

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

Drug Patent Watch

The post Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984 appeared first on DrugPatentWatch - Make Better Decisions. This article was originally published by Garth Boehm, Lixin Yao, Liang Hana, and Qiang Zheng in Acta Pharmaceutica Sinica under a creative commons license. Abstract The key events in the….

CPhI: Dramatic changes ahead for the generics market

Outsourcing Pharma

Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.

Sandoz incorporates RFID technology on injectables

Outsourcing Pharma

The generic drug manufacturer is working with Kit Check to incorporate the company's drug supply-chain management technology into two of its products.

EU Faces Remdesivir Shortages Amidst Sharp Spikes in New COVID-19 Cases


Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir Tuesday in the face of rising demands

Announcing the 2020 Science in Society Journalism Awards winners


We are pleased to announce the winners of the 2020 Science in Society Journalism Awards, sponsored by the National Association of Science Writers: In the Book category, Bottle of Lies: The Inside Story of the Generic Drug Boom, by Katherine Eban, published by Ecco/HarperCollins In the Science Reporting category, “Cigarette Butts Are Everywhere.

Customer Success: Formulary Management

Drug Patent Watch

You can preview these tools at: Recent Generic Drug Launches Upcoming 180-Day Patent Challenge Exclusivity Expirations Anticipate…. In response to customer requests, we’ve built some new tools for formulary management. The post Customer Success: Formulary Management appeared first on DrugPatentWatch - Make Better Decisions. Customer Success Stories Featured Insights

PharmacyChecker Helps Americans Save 99% on Medications… Domestically

Pharmacy Checkers

More than ever, if an American compares drug prices on, they will learn that most generic drugs are far cheaper domestically than in Canada – or, in some cases, even India. Many of you know that prices on the same brand name drugs sold outside the U.S.

Truvada for PrEP: availability, cost and side effects


Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is a brand name of a combination drug, which contains two antiviral medicines: emtricitabine and tenofovir disoproxil.

Valisure Supports Drug Importation

Pharmacy Checkers

online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Food and Drug Administration to make sure those drugs will work as directed by their prescribers.

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is. It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”. The FDA’s Role in Protecting Our Drug Supply.

Teva shares slide as it faces illegal kickback charges from US government

Pharma Phorum

Shares in Teva were down sharply this week after the US Department of Justice filed a complaint that the company paid illegal kickbacks to patient groups to boost sales of its multiple sclerosis drug Copaxone (glatiramer).

Even Drugs Manufactured in America are not “Made in the USA”

Pharmacy Checkers

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. 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.

FDA hands Cassiopea its first approval, for acne drug Winlevi

Pharma Phorum

Cassiopea claims that a drug that works by inhibiting androgen hormones in the skin is “game-changing” as it tackles aspects of acne not addressed by other drugs, and limits the systemic side-effect issues that limit the use of oral alternatives.

Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

Pharma Phorum

She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment.

Should Blink Health advertise Canadian drugs on Google?

Pharmacy Checkers

The company Blink Health is advertising Canadian drugs on Google, even though it does not sell medication from Canadian pharmacies. Blink Health advertising under the key phrase “drug prices in Canada” Launched in early 2016 , Blink Health offers consumers the ability to purchase prescription medicines from its app or website and pick them up from local pharmacies in their neighborhoods. Brand drugs cost way more at Blink Health than in Canada.

Buscopan vs Mebeverine | OTC IBS treatment


Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Drugs 67, 1343–1357 (2007).

China Opens the Door to Personal Medicine Imports and Third-Party Online Platform Sales

Pharmacy Checkers

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! The changes were part of a major overhaul of the Drug Administrative Law of the People’s Republic of China (DAL). A summary in English can be found here: Summary of Revised Chinese Drug Administration Law.

Amazon’s Pharmacy Should Support Importation to Offer Lower Drug Prices

Pharmacy Checkers

With drug prices in the spotlight of our national healthcare debate, one could certainly view Amazon’s entry last year into the pharmacy space as a welcome development. Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. drugs.

Mallinckrodt Receives Court Approval of “First Day” Motions to Support Business Operations

The Pharma Data

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. DUBLIN , Oct. 14, 2020 /PRNewswire/ — Mallinckrodt plc (“ Mallinckrodt ” or the “Company”) today announced that it has received approvals from the U.S. Bankruptcy Court for the District of Delaware for its “First Day” motions related to the Company’ s voluntary Chapter 11 petitions filed on October 12, 2020.

Canada’s Message to the U.S. on Drug Importation: We care more about our citizens than you.

Pharmacy Checkers

The pharma-funded and industry opponents of drug importation from Canada just love to talk about how “ even the Canadian government opposes importation.” That’s personal drug importation. When I write that Canada opposes importation, I mean the wholesale drug importation currently proposed by the Trump administration. to import drugs from Canada. This is mainly due to Canada’s fear of drug shortages.

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The FDA can prevent the importation of such drugs – but the agency is actually encouraged by law not to do so if the import is for personal use only. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

PMPRB launches consultation on revised Draft Guidelines

Pharma in Brief

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ). Medicines falling below these thresholds, as well as biosimilars and generics, will be classified as Category II.

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. Job vacancies seem to be endemic for foreign drug establishment FDA inspectors. Clearly, the FDA acknowledges the relative strength of the EU on drug safety.

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

No, not for raising a drug price – otherwise the jails would overflow with pharma execs – but for financial fraud related to his work as hedge fund manager. Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug. Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market.

Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit

Pharmacy Checkers

Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”. Our company, verifies online pharmacies, and compares drug prices among those accredited in our online pharmacy Verification Program. Its mission is to end the crisis of high prescription drug prices in America, and to do so on a bipartisan basis.

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S.

Trump’s Pakistani Imported Chloroquine Phosphate: FDA Inspections vs. EU Testing to Ensure Drug Safety

Pharmacy Checkers

In late March, drug giant Bayer Pharmaceuticals, out of the goodness of its heart, agreed to donate three million tablets of chloroquine phosphate to help the Trump administration get this drug into U.S. This post isn’t about our constant partisan divide or even Bayer or other evil drug companies, although they are referenced. I’m a big fan of testing prescription drugs to see if they have the right stuff (to put it eloquently). Bayer said it would donate the drugs.

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Prescription Justice was founded in 2015 to help end the crisis of a high drug prices in America. for drug safety. Part J(3) states: “ Drugs imported from Canada.

COVID-19 Pandemic Coverage


Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? “Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment.