India’s Orchid Pharma wins 180-day exclusivity for piperacillin and tazobactam injectables in US

Revenues from 180-day exclusive piperacillin and tazobactam sales to boost Orchid’s ensuing quarters

Indian generic maker Orchid Chemicals & Pharmaceuticals Ltd has received approvals from the US Food and Drug Administration (US FDA) for its antibiotic combination piperacillin and tazobactam for injection, with 180-day exclusivity to market the products in US.

Orchid Pharma got approvals covering its generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g dosage forms and strengths, the company announced in a press release.

Piperacillin and tazobactam for injection is an injectable combination product consisting of the semisynthetic antibiotic piperacillin sodium and the ?-lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin and tazobactam combination has activity against many gram-positive and gram-negative pathogens and anaerobes, including Pseudomonas aeruginosa.

Piperacillin-tazobactam injections is commercially available as Tazocin (UK, marketed by Wyeth),
Tazocin (Japan, marketed by Toyama), Tazocin (New Zealand, marketed by Wyeth), Zosyn (US, marketed by Wyeth) and Zobactin (India, marketed by GSK).

Chennai, south India-based Orchid Pharma is also determined to be the first-to-file under para IV abbreviated new drug applications (ANDAs) for generic by the USFDA. No other company will be allowed to sell piperacillin and tazobactam injectable products in the strenghs approved for Orchid within this exclusivity period.

Orchid’s firt-to-file status entitles the company to have 180-day generic drug exclusivity, under applicable provisions, with considerable upsides for the company.

“Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate significant contribution to our revenues and profitability from this product in the ensuing quarters,” stated K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd.

Orchid would launch piperacillin and tazobactam combination injectable products in marketing and distribution partnership with Apotex in the US.

Orchid received approvals from several countries in EU for launch of Piperacillin-Tazobactam Injections in the financial year 2008-09.

In July, Orchid Chemicals & Pharmaceuticals Ltd  received approval from the US FDA for its generic version of Pfizer’s  anti-hypertension pill amlodipine besylate (Norvasc) in  2.5 mg, 5 mg and 10 mg strengths, Orchid said in press release.

Orchid received tentative approval from the US Food and Drug Administration (US FDA) for its migraine pill sumatriptan succinate, in May.

During the 2008-’09 period, Orchid’s cumulative ANDA filings moved to 58 with 29 of the filings in the cephalosporins space, 5 in Betalactams, 21 in the NPNC segment and 3 in the Penems segments. These also include 7 Para IV FTF (First-to-File) ANDA filings.

In the Canadian market, Orchid’s cumulative count of ANDS approved moved to 5 with the recent approval received for Cefepime Arginine Injections. Of the total ANDS approved, 4 are in Cephalosporin Segment and 1 in the Betalactam segment.

Orchid’s cumulative filing count of Marketing Authorizations (MA) in the EU region moved to 29. Of these MA filings, 23 are in the cephalosporin segment, 1 in the penicillin injections segment, 2 in Carbapenem Segment and 3 in NPNC segment. Orchid has cumulatively received 19 MA approvals so far.

In the Active Pharmaceutical Ingredients (API) segment, Orchid increased the cumulative filings of its US DMF count to 72. The break-up of the total filings is 26 in the cephalosporin segment, 33 in NPNC segment, 2 in the betalactam segment and 11 in the carbapenems segment.

In the European market, the cumulative filings of CoS (Certificate of Suitability) count remained at 20 which includes 12 in cephalosporin segment, 7 in NPNC segment and 1 in the betalactam segment.

Orchid had also made its first Japanese DMF filing during the fourth quarter of the fiscal under review. The cumulative DMF filing count in Japan as of date stands at 3, according to company statements.

Orchid Chemicals & Pharmaceuticals Ltd registered a turnover and operating income of Rs 1211.27 crore for the fiscal year ended March 31, 2009 compared to the previous year’s revenues of Rs 1240.14 crore.

The company registered a loss after tax of Rs 52.17 crore as against a profit after tax of Rs 184.54 crore registered during the last fiscal.

Earnings before Interest & Tax (EBIT) stood lower at Rs 157.77 crore compared to Rs 248.40 crore of the last fiscal.

The fiscal 2008-09 witnessed a plateau in the US generics business of Orchid. The dip is partly attributed to the overall recession in the US economy with the distributors and trade channels at large being cautious with orders.