Home Active Pharmaceutical Ingredients (API)Empagliflozin MSN Labs and Dr. Reddy`s Labs launched Patented Anti-Diabetic Pill Jardiance (Empagliflozin), leads to a Potential Legal Battle

MSN Labs and Dr. Reddy`s Labs launched Patented Anti-Diabetic Pill Jardiance (Empagliflozin), leads to a Potential Legal Battle

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Keypoints

  • MSN Laboratories on Monday has launched the most affordable copies of Jardiance (Empagliflozin), the top-selling patented anti-diabetes pills sold by German drugmaker Boehringer Ingelheim (BI).
  • Dr. Reddy’s Labs has launched copies of Jardiance, a hit anti-diabetes pill sold by German drugmaker Boehringer Ingelheim (BI).
  • Jardiance (Empagliflozin) has a valid patent in India until 2025.
  • This will be the first instance that Dr. Reddy`s lab has launched copies of a brand with a valid patent.
  • Cipla and Lupin also market the Empagliflozin under license from BI.
  • Boehringer Ingelheim notes, “We have information about a generic Empagliflozin molecule launch by a domestic pharma manufacturer, which could be an instance of patent infringement.

 

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MSN Labs and Dr. Reddy`s Labs launches Patented Anti-Diabetic Pill Jardiance (Empagliflozin).

Hyderabad-based drugmaker MSN Laboratories on Monday said it has launched the most affordable copies of Jardiance (Empagliflozin), the top-selling patented anti-diabetes pills sold by German drug maker Boehringer Ingelheim (BI).

MSN said its Empagliflozin tablets to be sold under brand name ‘EMPAONE’ will cost Rs 15.90 and Rs 18.90 for each 10 mg and 25 mg tablet respectively, while Jardiance 10 mg and 25 mg prices costs Rs.51.3 and Rs 62.2 per pill.
“‘EMPAONE’ is intended to provide diabetes patients in need across India with an affordable and accessible therapeutic option,” MSN said in a release.
The Hyderabad-based drugmaker said it has developed the active pharmaceutical ingredient (API) and the finished dosage formulation (FDF) of EMPAONE at its in-house state-of-the-art R&D center.
“The development is fully indigenous right from conceptualization to API development and FDF,” MSN said.
ET on Monday reported that Hyderabad-based Dr. Reddy’s Labs has launched copies of Jardiance, which has valid patent in India until 2025 and experts say the launch is likely to take a controversial spin and head for a court battle. BI may seek temporary restraining order and claim.
Cipla and Lupin also market the Empagliflozin under license from BI.
“We have information about a generic Empagliflozin molecule launch by a domestic pharma manufacturer, which could be an instance of patent infringement. We are exploring options to protect our rights as the active patent holder of Empagliflozin. We have faith in the Indian Patent system and the enforcement of patent rights, which is imperative to drive patient-centered progress and innovation,” BI said.
India has 77 million people suffering from Type 2 diabetes. According to IQVIA data as of Aug. 2021, India’s anti-diabetes drugs market was at Rs. 16306 crore, growing annually at 9%. Of that, SGLT2 plain and combinations swelled to Rs. 969 crore and 487 crores respectively, which is the fastest among all other classes of anti-diabetes drugs.

 Dr. Reddy launched copies of Jardiance.

Hyderabad-based Dr. Reddy’s Labs has launched copies of Jardiance, a hit anti-diabetes pill sold by German drugmaker Boehringer Ingelheim (BI). The drug has a valid patent in India until 2025 and experts say the launch is likely to take a controversial spin and head for a court battle. BI may seek a temporary restraining order and claim damages for patent infringement.
Jardiance leads a class of drugs named SGLT-2 (sodium-glucose co-transporter-2) that works by helping the kidneys cut glucose from the bloodstream and minimize renal damage and other debilitating complications linked with chronic diabetes. Sales of Jardiance stood at roughly ₹250 crores till August this year, based on the 12-month moving annual total (MAT), according to IQVIA, a global data science, and pharma consulting firm.
Under its brand Vicar, Dr. Reddy is expected to sell the drug in India at less than a third of the price charged by Boehringer Ingelheim. According to sources, the 10 mg variant of Dr. Reddy’s brand may cost ₹15 per tablet against ₹51 of the innovator’s brand. For the 25 mg variant, the price will be ₹18 per tablet against ₹62 of BI’s drug. Online pharmacy 1mg shows Jardiance is sold at a 25% price discount.

The decision of Dr. Reddy’s surprised many in the industry since this will be the first instance that the company has launched copies of a brand with a valid patent.
In a similar action, in April 2013, Mumbai-based Glen mark had launched cut-price versions of US giant Merck’s blockbuster Januvia, under its brand name Zita. After an acrimonious court battle revolving around patent infringement, Glenmark lost the case in Supreme Court in 2015 and was ordered to withdraw its brand from the market.
In response to questions from ET, a spokesperson from Boehringer Ingelheim notes, “We have information about a generic Empagliflozin molecule launch by a domestic pharma manufacturer, which could be an instance of patent infringement. We are exploring options to protect our rights as the active patent holder of Empagliflozin. We have faith in the Indian Patent system and the enforcement of patent rights, which is imperative to drive patient-centered progress and innovation.”
It added we expect all responsible corporate citizens to uphold Boehringer Ingelheim’s valid patent for Empagliflozin.
Dr. Reddy did not respond to queries from ET.
According to IQVIA data as of Aug. 2021, India’s anti-diabetes drugs market was at Rs. 16306 crore, growing annually at 9%. Of that, SGLT2 plain and combinations swelled to Rs. 969 crore and 487 crores respectively, which is the fastest among all other classes of anti-diabetes drugs.

What is Empagliflozin?

Empagliflozin, sold under the brand name Jardiance among others, is a medication used together with diet and exercise to treat type 2 diabetes. It can be prescribed instead of metformin and has benefits over sulfonylureas. It may be used together with other medications such as metformin or insulin. It is not recommended for type 1 diabetes. It is taken by mouth. In view of recent trial evidence, it is expected to soon receive licence to be used for patients with heart failure, irrespective of diabetic status.

FDA Approval:

Empagliflozin was approved for medical use in the United States and in the European Union in 2014. In 2017, it was the 228th most commonly prescribed medication in the United States, with more than two million prescriptions.

Medical uses        

Type 2 diabetes

Empagliflozin is used in combination with proper diet and exercise to help people with type 2 diabetes lower their blood sugar levels. It can be used alongside other medications for type 2 diabetes such as metformin, sulfonylureas, and insulin. When compared to a placebo, Empagliflozin led to a drop of 0.7% in haemoglobin A1c, a long-term marker of blood glucose levels.

Weight and blood pressure

Empagliflozin causes moderate reductions in blood pressure and body weight. These effects are likely due to the excretion of glucose in the urine and a slight increase in urinary sodium excretion. In clinical trials, patients taking empagliflozin lost an average of 2% of their baseline body weight. A higher percentage of people taking empagliflozin achieved weight loss greater than 5% from their baseline. The medication reduced systolic blood pressure by 3 to 5 millimeters of mercury (mmHg). The effects on blood pressure and body weight are generally viewed as favorable, as many patients with type 2 diabetes have high blood pressure or are overweight or obese.

Heart & kidney disease

SGLT2 inhibitors, including empagliflozin, appear to reduce the likelihood of hospitalization for heart failure or progression of chronic kidney disease in persons with type 2 diabetes. Empagliflozin may reduce the likelihood of death due to cardiovascular causes in people with type 2 diabetes who have known cardiovascular disease. One concern regarding the trial on which these claims are based is that the different arms received different amounts of other medications; thus, the reduced risk cannot necessarily be attributed to empaglifozin. In some countries it has also been approved to reduce the risk of death from cardiovascular causes in people with type 2 diabetes and heart disease.

Treatment guidelines

Guidelines by the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) recommend SGLT-2 inhibitors like empagliflozin as second-line medications after metformin for type 2 diabetes in people with heart failure or chronic kidney disease. For type 2 diabetes with established cardiovascular disease, the guidelines recommend either a SGLT-2 inhibitor or a GLP-1 agonist as second-line medications after metformin. In all other type 2 diabetes cases, SGLT-2 inhibitors like empagliflozin can be appropriate second-line options if blood glucose control or weight loss are treatment priorities. They are less appropriate if cost is a major factor.

In the United Kingdom empagliflozin is typically only recommended together with metformin if a sulfonylurea cannot be taken.

Type 1 diabetes

Empagliflozin is not recommended for type 1 diabetes. One trial studied its use in addition to insulin in people with type 1 diabetes. The medications delivered modest improvements in blood glucose control and body weight but were associated with an increased risk of diabetic ketoacidosis, a dangerous complication of diabetes. Empagliflozin is not approved by the U.S. Food and Drug Administration (FDA) for use in type 1 diabetes.

Mechanism of action (MOA):    

Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), which is found almost exclusively in the proximal tubules of nephronic components in the kidneys. SGLT-2 accounts for about 90 percent of glucose reabsorption into the blood. Blocking SGLT-2 reduces blood glucose by blocking glucose reabsorption in the kidney and thereby excreting glucose (i.e., blood sugar) via the urine.

WHAT IS PATENT INFRINGEMENT?

When an unauthorized party sells, imports, uses, or makes a product that someone else holds the patent on without permission, patent infringement has occurred. All patent information is publicly accessible and governed by federal law. If a patent holder detects patent infringement and wishes to sue, they must bring their case to the federal district court within six years from the date of infringement.

TYPES OF PATENT INFRINGEMENT

There are four different types of patent infringement that may be taken by the unauthorized party:

Direct Infringement: When a product covered by a patent is manufactured without the patent holders permission.

Indirect Infringement: When an unauthorized party may encourage or aid another in infringing upon a patent.

Contributory Infringement: When an unauthorized party supplies a direct infringer with a part that has no substantial non-infringing use.

Literal Infringement: When there is a direct correspondence between the words in the patent claims and the infringing product or device or technology.

Willful Infringement: When another person or company purposely uses the patent holder’s ideas or products. This can result in court awarded treble damages.

About Boehringer Ingelheim:

C.H. Boehringer Sohn AG & Ko. KG is the parent company of the Boehringer Ingelheim group, which was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. As of 2018, Boehringer Ingelheim is one of the world’s largest pharmaceutical companies, and the largest private one. Headquartered in Ingelheim, it operates globally with 146 affiliates and more than 47,700 employees. Unlike most large pharmaceutical companies which are listed, the company is private and fully owned by the Boehringer, Liebrecht and von Baumbach families. The company’s key areas of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The corporate logo of Boehringer Ingelheim depicts a stylized rendition of the central section of the imperial palace of Charlemagne.

About MSN labs:

MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has nine API and five finished dosage facilities established across Hyderabad, USA and Myanmar.
The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following:

  • More than 650 national and international patents
  • Product portfolio featuring over 350 + APIs
  • 250+ Formulations, covering over 35 major therapies
  • Won the trust of more than 40,000,000 customers across 65 countries globally

Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 11,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

In a short span of 17 years, MSN has achieved a record growth of 100% from USD 22 million in 2005 to USD 500 million in 2019. Outstanding workforce, cutting-edge science, state-of-the-art technology and knowledge-intensive initiatives – our work involves creating innovative solutions for tomorrow’s healthcare requirements.

About Dr. Reddy`s Labs:

Headquartered in Hyderabad, India, Dr. Reddy’s Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Abiraterone Acetate API. Dr. Reddy’s API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East, and other emerging markets.

Dr. Reddy’s API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long-chain molecules, and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy’s Abiraterone Acetate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

For more Information: Sign-in Websites for Agrochemical & Pharmaceutical Databases:

Website: https://www.chemrobotics.com/ (Agrochemical Databases)

Website: https://chemroboticspharma.com/ (Pharmaceutical Databases)

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