Ahmedabad-based Lincoln Pharmaceuticals is awarded a patent for its liquid diclofenac metered dose rectal spray (diclofenac rectal spray). The patent has been awarded by the Government of India for “A Novel Liquid Rectal Spray Dosage Form Containing Diclofenac and Its Pharmaceutically Active Salts”, patent number – IN320894. Valid for 20 years, the company has necessary approvals from the Drug Controller General of India (DCGI) and is planning to launch it in the Indian market by January 2020. It is also planning to apply for a global patent for this novel solution.
Lincoln Pharma’s liquid rectal spray dosage offers faster and better absorption of the drug resulting in quick relief and speedy recovery to patients compared to the existing therapeutic options. Clinical trials conducted suggest that the spray is highly effective in patients suffering from pre and post-operative pain, gynaecological surgery and musculoskeletal disorders such as muscular pain, pain associated with arthritis, acute pain in renal colic and mild body ache.
Speaking on this development, Mahendra Patel, Managing Director, Lincoln Pharmaceuticals, said, “Globally, no liquid formulation of diclofenac for rectal administration is available. Lincoln Pharma will be the first company to introduce this novel solution aimed at better patient compliance, rapid drug release and greater bioavailability. We have developed this formulation with diclofenac sodium BP 25% W/V, each squirt delivers diclofenac sodium 50 mg, Non-Steroidal Anti-inflammatory Agent (NSAIDs). Due to this innovation, patients can now get far better results by using diclofenac rectal spray as compared to the existing diclofenac suppository available in the market. We are planning to apply for a global patent for this solution.”
Diclofenac rectal suppository market is Rs 20 crore in India and growing at 16 per cent per annum. The company sees huge export potential for this product and will start product registration in markets including African continents, Latin America and Southeast Asian markets and gradually expand to other markets.
The company has filled over 20 patent applications and is awarded five patents. It has developed 300 plus formulations in more than 15 therapeutic areas including anti-infectives, respiratory system, cardio and CNS, anti-bacterial, anti-diabetic and anti-malaria, among others.