Troikaa patents painless diclofenac injection Dynapar AQ

The diclofenac 75mg / 1ml injection is used to manage acute pain.

Ahmedabad-based Troikaa Pharmaceuticals, has received Indian patent for its high concentration diclofenac injection – Dynapar AQ.

Diclofenac injections are routinely used for management of acute pain and inflammation. Dynapar AQ is a painless diclofenac injections. Dynapar AQ is the only diclofenac injections in the world that can be administered in the arm muscles.

Diclofenac 75mg / 1ml injection is introduced for the management of acute pain. Unlike conventional diclofenac, 1ml Dynapar AQ Inj. can be given intra-deltoid as well. Multicentric clinical studies have proven the efficacy and safety of 75mg/1ml Diclofenac injections. Bioequivalence studies show that Dynapar AQ 1ml inj. offers higher bioavailability compared to conventional 3ml Diclofenac inj.

The novel drug delivery composition and the process of its manufacturing have been patented in 28 countries. In another 71 countries, the process of sealing the patents is in progress. 

Dynapar AQ injection is now ranked second in the diclofenac injections category, on ORG-IMS with annual sales of Rs 21 crore. Dynapar is enjoying a growth of 50 per cent year on year basis.

Department of Scientific and Industrial Research (DSIR), Government of India, has also conferred the DSIR-National Award for Research & Development to Troikaa Pharmaceuticals, for indigenously developing this world class product.

Troikaa is now in the process of launching Dynapar AQ in several countries across the world either directly or by out-licensing it to other companies in the important markets of the world.

Troikaa applied for the patent in February 2005. But the grant of permission by Indian patent office was delayed due to a series of oppositions filed by other Indian pharma companies.

“Under the Indian Patent Act, a patent cannot be granted, till each opponent has been given a hearing by the patent office. Since each opposition was filed subsequent to the previous one being overcome by Troikaa, the process of granting the patent went beyond the stipulated one year period from the date of the patent application being published in the Patent Office Journal. Troikaa, successfully defended all the oppositions and was finally granted the Patent in March 2009, four years after applying for it,” said Ketan Patel, managing director, Troikaa Pharmaceuticals.

Though Troikaa faced several oppositions from Indian companies against granting a patent for Dynapar, AQ, no opposition came from the MNC which leads in the diclofenac injection segment, the company said in a press statement.

Simultaneous to the Indian patent application, the company had initiated the process of obtaining patents for the said invention in 99 countries, at World Intellectual Property Office, Geneva. Thereafter, the company has dealt with the patent offices in each of the 99 countries to comply with the necessary procedures so as to be granted the patent in respective countries. So far, the patent has not been opposed in any other country.

Troikaa Pharmaceuticals has been granted the patent in 29 countries and the process of obtaining patents in the rest of the countries is nearing completion. Established in the year 1984, Troikaa Pharma is based in Ahmedabad, western India. 

Troikaa’s state-of-the-art manufacturing facilities are certified by the World Health Organization for following Good Manufacturing Practices and its Quality Management Systems certified by KVQA to follow ISO 9001:2000 standards for manufacturing and supply of Drugs and Pharmaceuticals.