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Lincoln Pharmaceuticals Ltd on Tuesday announced that the company was awarded a patent for its liquid Diclofenac Metered-Dose Rectal Spray (Diclofenac Rectal Spray).
The solution will offer better absorption of the drug resulting in quick relief and faster recovery to patients suffering from pre- and post-operative pain, gynaecological surgery and musculoskeletal disorders.
The patent has been awarded by the government for “A Novel Liquid Rectal Spray Dosage Form Containing Diclofenac and Its Pharmaceutically Active Salts” with patent number - IN320894, the company informed here.
The validity for the patent is 20 years, while it has secured necessary approvals from Drug Controller General of India (DCGI). Lincoln plans to launch the product in the Indian market by January 2020.
Eyeing global patent
The company is also planning to apply for a Global Patent for this novel solution.
The 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 that were conducted, suggest that Diclofenac Rectal Spray is highly effective in patients suffering from pre- and postoperative 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 Ltd, said, “Globally, there is no liquid formulation of Diclofenac for rectal administration available. Lincoln Pharma will be the first company to introduce this solution aimed at better patient compliance, rapid drug release and greater bio-availability.”
“We have developed this formulation with Diclofenac Sodium BP 25 per cent W/V, each squirt delivers Diclofenac Sodium 50 mg, non-steroidal Anti-inflammatory Agent (NSAIDs). Due to this innovation, now patients can get far better results by using Diclofenac Rectal Spray as compared to the existing Diclofenac Suppository available in the market,” Patel said.
The market for Diclofenac Rectal Suppository is estimated at ₹20 crore in India with a growth of 16 per cent per annum. There is huge export potential for the product and the company plans to start product registration in markets, including African continents, Latin America and South-East Asia and gradually expand to other markets.
The company has developed 300 plus formulations in 15 plus therapeutic areas, including anti-infectives, respiratory system, cardio & CNS, anti-bacterial, anti-diabetic, anti-malaria among others.
Lincoln Pharma shares gained over 6 per cent on NSE to trade at ₹162.90 on Tuesday.
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