US court rejects Wyeth’s lawsuit against USFDA for approving Orchid Pharma’s piperacillin and tazobactam generic injectable

India’s Orchid Pharma secured approval with 180-day marketing exclusivity for generic Zosyn (piperacillin and tazobactam injectable) in US last week

US District Court in Washington, DC has denied Wyeth’s appeal to block the sale of Orchid Pharma’s piperacillin and tazobactam injectable a generic version of Wyeth’s Zosyn antibiotic, reports said.

US drugmaker Wyeth  filed a lawsuit against US Food and Drug Administration seeking a restraining order to block the sale of generic piperacillin and tazobactam combination injection product for which India’s Orchid Pharma secured approval with 180-day marketing exclusivity in US last week.

Orchid Pharma’s piperacillin and tazobactam combo injectable is a generic version of Wyeths’s  intravenous antibiotic Zosyn.

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. Orchid’s firt-to-file status also entitled the company to have 180-day generic drug exclusivity, under applicable provisions.

Wyeth claims that Orchid’s piperacillin and tazobactam for injectable generic is not a therapeutically equivalent product and could harm critically ill patients.

Wyeth filed the lawsuit in U.S. District Court in Washington, D.C., seeking a temporary restraining order and a preliminary or permanent injunction.

The lawsuit seeks to prevent Orchid Chemicals & Pharmaceuticals Ltd. of Chennai, India, from selling a generic version of Zosyn.

Wyeth’s suit also appealed the court to order the FDA to withdraw its approval of Orchid’s products or any generic versions that aren’t exactly the same as Zosyn.

Orchid’s piperacillin and tazobactam generic formulation uses an administration mode which could cause serious medical errors and harm the patients.

Orchid’s generic injection uses the same intravenous (IV) line for the piperacillin and tazobactam leaving ample scope for mix up with the intravenous solution leading to a chemical reaction that inactivates the antibiotic, Wyeth claims.

Wyeth, which was using the same IV line method to administer Zosyn (piperacillin and tazobactam) in an earlier version, discontinued it in October 2005, when the FDA approved a newer version that adds two ingredients to prevent the harmful chemical reaction.

Having two Zosyn versions in use could result in confusion among hospital workers as they rush to set up an intravenous line to rapidly feed in both Zosyn and, often, a standard IV solution to boost blood volume and pressure.

Over 2 million people recieve piperacillin and tazobactam IV every year and patient safety is at stake and that Orchid’s product could lead to preventable medical errors.

In view of these, US FDA’s approval of Orchid’s piperacillin and tazobactam products “arbitrary, capricious, an abuse of discretion” and “unlawful.” The approval “permits the marketing of a generic drug product that cannot be safely used in the same manner as the branded product” and “seriously endangers patient health,” the lawsuit alleges.

Wyeth had filed a “citizen’s petition” several years ago asking US FDA not to approve generic Zosyn citing arguments on medication errors and drug interactions and effects.

However, US FDA denied the citizen’s petition and approved Orchid’s piperacillin and tazobactam products.

Wyeth’s Zosyn has has sales of around $1.3 billion in US. Zosyn was approved in US market in 1993.

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).

Orchid’s generic piperacillin and tazobactam injectable products have already been launched in the United States in distribution partnership with Apotex.

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 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.