Dapagliflozin NOT off Patent, says AstraZeneca

With the so-called "patent" of the Dapagliflozin held by AstraZeneca expiring last month, in India, many Indian companies were reportedly lurking to introduce an affordable, generic version of the drug. However, soon pointing out that the patent that had expired was " genus patent" and that the "species patent" still had its validity till 2023, AstraZeneca took 12 Indian drugmakers in Delhi high court for allegedly eyeing to roll out a cheaper generic version of its drug globally marketed the drug under brand names Farxiga and Forxiga.

The drugmaker has licensed sales of Dapagliflozin in India by Sun Pharma and Abbott Healthcare via an agreement

Also Read: Price War Over Diabetes Drug Dapagliflozin: AstraZeneca Drags 12 Drugmakers To Delhi Court

Medical Dialogues team asked Dr Anil Kukreja, Vice President - Medical Affairs & Regulatory, AstraZeneca India about the journey of Dapagliflozin and the Brand Forxiga, and here is what he had to say

Q. Briefly describe the Journey of Dapagliflozin in the past 10 years.

Dapagliflozin 5mg and 10mg was approved in India on 25th Feb 2015 for Type 2 Diabetes Mellitus patients to improve glycemic control. Thereafter, we have also received approval on 30th July 2019 to include additional information about the therapeutic effects of Dapagliflozin on glycemic control and cardiovascular event under clinical section. On 3rd July 2020, we further received approval for the additional indication – HEART FAILURE with reduced ejection fraction for Dapagliflozin 10mg tablets.

Current Approved Indications – In adults aged 18 years and older with type II diabetic mellitus to improve glycemic control. As mono-therapy when diet and exercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered in appropriate due to intolerance.

As add on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.

During these years, we have contributed in generating quality evidence through participation in global clinical trials with more than 1000 patients enrolled from India in different clinical trials which has enabled us to get regulatory approvals in India.

Q. With the drug going off-patent, what is the way forward for the brand Forxiga particularly in India?

We would like to clarify that Dapagliflozin is not "off-patent" and is very much under patent protection in India. It is only the Genus patent for Dapagliflozin which expired, and the Species patent continues to be in force up to 15 May 2023. We have taken necessary legal action to defend our exclusive rights to the Dapagliflozin and these cases are currently before the Delhi High Court.

AstraZeneca is putting in efforts with continuous research and development with Dapagliflozin expanding the horizons to various other indications. The clinical trials are completed for Chronic Kidney disease and global submissions to Health Authority has been rolled out with India submission being first in Global. In addition, trials are ongoing/planned for heart failure with preserved ejection fraction (HFpEF), Myocardial Infarction (MI), T1DM. The HA submissions for approval in India will be planned based on the study outcomes.

Q. The drug was launched as a diabetes drug, but the new evidence points to its usefulness in the indications of heart failure. In the light of the above, what is the future plan for the drug- molecule?

Data is evolving at fast pace around Dapagliflozin. Earlier this year we got an additional indication approval for management of Heart Failure with reduced Ejection fraction with or without Type 2 Diabetes Mellitus. currently, Dapagliflozin is the first and only drug approved in India for the management of Heart Failure with reduced Ejection fraction. In addition, we presented and published positive results from our DAPA-CKD study, these data are currently submitted to the regulatory agency for new indication review and approval. A study is also underway to evaluate the effect of Dapagliflozin on HF patients with preserved ejection fraction, currently, there are no treatment options available for this type of Heart failure patients, results are expected to be available in 2021

Q. Medical fraternity is confused about the patent status of Dapagliflozin with regards to its genus and specific patent. Can you through some light on the same?

In the pharmaceutical sector, inventions can relate to several aspects of a single product such as for an entire class of compounds having a certain core structure and specific properties, as also a specific molecule within the said class as possibly the best compound with the ideal pharmacological, biological, chemical and physical properties. Consequently, a single medicine/product can be protected by a large number of separate patents, each relating to a different invention.

With regards to the patent status of Dapagliflozin, the genus patent (which is a patent over the basic scaffold, or the basic structure and covers millions upon millions of compounds having the said chemical structure which can emanate from that basic scaffold) associated with the compound expired on 2nd October 2020; however, the species patent continues to be in force up to 15th May 2023. Exclusive rights to Dapagliflozin vest with AstraZeneca till May 2023, and we have taken steps in law to protect and enforce these exclusive rights till then.

Q. With the drug going off the patient, How will DAPA (FORXIGA) be different from generic counterparts?

We would like to clarify that Dapagliflozin is not "off-patent" and is very much under patent protection in India. It is only the Genus patent for Dapagliflozin which expired, and the Species patent continues to be in force up to 15 May 2023. We have taken necessary legal action to defend our exclusive rights to the Dapagliflozin and these cases are currently before the Delhi High Court.

We cannot comment on the properties, safety, quality and efficacy of generic versions of Dapagliflozin. However, we can vouch for the quality, efficacy of Forxiga, which has consistently demonstrated great success with diabetes treatment over the years and more recently proven benefits beyond glycemic control in the management of Heart failure with reduced ejection fraction, not just in India but in many countries of the world.