1. Merck files patent infringement petition against Aurobindo Pharma in the US over Janumet :
Pharma news – 27 August: Merck & Co’s subsidiary Merck Sharp & Dohme Corp. has recently filed a patent infringement petition in the US[1] court. This petition is filed against Aurobindo Pharma for allegedly creating a generic version of Merck’s patented product.
This petition was filed in the third week of August 2020 in the US District Court for the District of Delaware on four counts. Merck has claimed that Aurobindo Pharma has submitted the ANDA[2] for its generic version to the USFDA[3]. It further added that Aurobindo Pharma plans to manufacture and sell its generic version prior to the expiry of its 708 patents. Merck has also requested the court to prevent Aurobindo Pharma from marketing its generic version till the end of the patent period.
In June 2020, Merck had filed a petition against Dr. Reddy’s Laboratories in the US court. This case too was filed over patent issues on Janumet and Januvia.
As per paragraph IV of Patent Certifications, the sale of a generic version of the patented product is permitted even before the expiry of the patent. But for this to be feasible, the company is expected to get the FDA’s approval first.
Patent litigation cases are quite common in the US and these do not affect the performance of the company.
Janumet is a patented product of Merck & Co that is a combination of Metformin hydrochloride and sitagliptin phosphate. It is used for treating high blood pressure in type II diabetic patients. Its patent will expire on July 2022 in the US along with a six-month pediatric exclusivity.
Janumet earned around USD[4] 2 billlion revenues globally in 2019. Out of this, around USD 589 million was cloaked from the US market alone as per Merck’s annual report 2019.
Abbreviation : 1. United States
- Abbreviated New Drug Application
- United States Food and Drug Administration
- United States Dollar
2. AstraZeneca begins clinical trials of its Covid-19 drug in the United Kingdom :
Pharma news – 27 August: On 25 August 2020, AstraZeneca announced the beginning of its Covid-19 drug, AZD7442. It is a combination of two antibodies and is used to treat Covid-19.
Around 48 healthy people aged between 18 to 55 years are recruited for this project. This trial aims to provide information on the safety of the drug. Scientists believe that this drug is capable of treating Covid-19 and preventing its progression in infected patients.
The results of the trial are expected by the end of 2020.
Apart from this latest trial, AstraZeneca has also partnered up with the University of Oxford, This partnership was established for the development of a separate coronavirus vaccine.
3. U.S. Justice Department charges Teva Pharma of the price fixing of generic drugs :
Pharma news – 27 August: On 25 August 2020, the US[1] Justice Department charged Teva Pharmaceuticals for price fixing. The department claimed that Teva joined hands with other competitors to raise the price of generic drugs in the market.
The company has refused these allegations and is currently defending itself. It has also refused to go along with the settlement and pay any criminal penalty.
The next indictment was filed in the US District of Pennsylvania. Per this, Teva is filed with three counts for conspiring with companies like Glenmark Pharma, Apotex Corp, Taro Pharmaceutical Industries and Sandoz Inc.
In the first charge, Teva, Glenmark and Apotex pharma are alleged of increasing the price of Pravastatin and other generic drugs. In the second charge, Teva and Taro are accused of increasing the prices, rigging bids and allocating customers for drugs. These customers were usually patients who are consuming drugs used for treating arthritis, blood clots, skin, seizure and blood cost. In the third charge, Teva and Sandoz are accused of price fixing of drugs. The drugs used in brain cancer, hypertension, cystic fibrosis and arthritis are the ones involved in the third charge.
In the first charge, Teva, Glenmark and Apotex pharma are alleged of increasing the price of Pravastatin and other generic drugs. In the second charge, Teva and Taro are accused of increasing the prices, rigging bids and allocating customers for drugs. These customers were usually patients who are consuming drugs used for treating arthritis, blood clots, skin, seizure and blood cost. In the third charge, Teva and Sandoz are accused of price fixing of drugs. The drugs used in brain cancer, hypertension, cystic fibrosis and arthritis are the ones involved in the third charge.
Apotex, Taro and Sandox have already accepted their crimes and have agreed to pay the penalty.
In July 2020, a Grand jury returned an indictment against Glenmark for its role in the alleged conspiracy.
Abbreviation : 1. United States
4. Aleor Dermaceuticals receives USFDA’s approval for marketing its Desonide lotion :
Pharma news – 27 August: On 25 August 2020, drug major Aleor Dermaceuticals received the USFDA’s[1] approval for marketing its Desonide lotion. The strength of this lotion is 0.05 percent.
Desonide lotion is a generic version of the patented product, DesOwen lotion (0.05%) of Galderma Laboratories LP.
Desonide lotion is a low to medium potency corticosteroid. It is used for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
The market size of desonide lotion for the past 12 months ending on June 2020 was found to be around USD[2] 7 million. Alembic Pharma has around 129 ANDA[3] approval. Of these, 113 have received final approval and 16 have received tentative approvals from the USFDA.
Abbreviation : 1. United States Food and Drug Administration
2. United States Dollar
3. Abbreviated New Drug Application
5. Alembic Pharma receives FDA’s tentative approval for multiple strength of type-2 diabetes drugs:
Pharma news – 27 August: Alembic Pharma has received the USFDA’s[1] tentative approval for its Empagliflozin and Linagliptin tablets. Multiple strengths of these tablets have received the green signal from the regulatory body.
The company claimed that this product is the generic version of Glyxambi tablets. This tablet is a branded drug of Boehringer Pharmaceuticals Inc. It contains either 10 mg/5 mg or 25 mg/5 mg of Empagliflozin and Linagliptin.
This combination is used to improve glycemic control in adults with type-2 diabetes mellitus. Empagliflozin as such reduces the risk of cardiovascular death in adults with type-2 diabetes. But the effectiveness of this combination in reducing cardiovascular risk is unknown.
The market size of the 10 mg/5 mg and 25 mg/5 mg tablets is around $244 million. This is the estimated market size for 12 months ending in June 2020 as per the IQVIA[2].
Alembic Pharma is currently involved in a litigation case with Boehringer in the District Court of Delaware. The launch and subsequent sale of this product depend upon the outcome of this litigation.
Abbreviation : 1. United States Food and Drug Administration
2. Formerly known as Quintiles and IMS Health, Inc.
References :
- [1] – News 18 Business – 25 August 2020
- [2] – Economic Times – 25 August 2020
- [3] – Economic Times – 26 August 2020
- [4] – CNBCTV 18 – 25 August 2020
- [5] – Business Standard – 27 August 2020
- Pharma News – 23.01.2023 to 29.01.2023
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