INDIA – Global pharma major Lupin has scored approval from the United States Food and Drug Administration (U.S. FDA) for its oral contraceptive Turqoz tablets.

Lupin’s Turqoz tablets are a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol.

The Mumbai-based drugmaker has FDA approval for its abbreviated new drug application (ANDA), Turqoz (Norgestrel and Ethinyl Estradiol Tablets) in 0.3mg strength.

In a press release, Lupin said: “Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg, is a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC.”

The FDA’s authorization of Lupin’s generic oral contraceptive pills comes as women’s health rights and issues regarding reproductive health gain traction in the United States.

Comparably, the FDA has given the green light to Perrigo’s Opill (norgestrel) for over-the-counter use.

This approval marks a significant milestone as Perrigo’s Opill is the first hormonal oral contraceptive available without a prescription in the United States.

Increased awareness about the benefits and use of contraceptives is a major factor driving the hormonal contraceptives market.

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of US$34 million in the United States as of March 2023, according to evidence-based data from IQVIA.

After the FDA approval, Lupin is expected to strengthen its presence in the women’s health area with the sale of its oral contraceptive Turqoz tablets.

Lupin will soon begin manufacturing generic Turqoz tablets at its facility situated in Pithampur in the city of Indore in the heart of Madhya Pradesh in India.

It is an important step forward in the company’s mission of providing accessible and affordable quality healthcare to individuals and families in India.

Moreover, Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).

The drug maker has reported sales in over 100 markets in the United States, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Hence, Lupin is set to further solidify its presence in the global hormonal contraceptives market, which is valued at approximately US$13.78 billion in 2023.

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