Close

Mylan NV Launches First Generic Doryx Delayed-Release Tablets, 200 mg

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

Meribel Pharma Solutions launches with big ambitions to elevate pharma services to new heights

A new, mid-size Contract Development Manufacturing Organisation (CDMO), Meribel...

Berry to Showcase Latest Technologies for Fast-to-Market, Patient-Centric Solutions

Solutions for patient-centred drug delivery devices that enhance dosing,...

Steriline’s Advanced Filling Innovations Exhibited At Interphex 2025

New York City, March 25, 2025 – Steriline, a well-established European manufacturer...

Mylan N.V. announced the U.S. launch of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 200 mg, a generic version of Mayne’s Doryx®. Mylan received final approval from the U.S.

Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity for this product. Doxycycline Hyclate DR Tablets are a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne.

Doxycycline Hyclate DR Tablets USP, 200 mg, had U.S. sales of approximately $181.8 million for the 12 months ending March 31, 2016, according to IMS Health.

Currently, Mylan has 258 ANDAs pending FDA approval representing $109 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $37.4 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

About Mylan NV
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our nearly 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at www.mylan.com.

For further information:

Nina Devlin (Media),
724.514.1968,

Kris King (Investors),
724.514.1813

Latest stories

Related stories

Meribel Pharma Solutions launches with big ambitions to elevate pharma services to new heights

A new, mid-size Contract Development Manufacturing Organisation (CDMO), Meribel...

Berry to Showcase Latest Technologies for Fast-to-Market, Patient-Centric Solutions

Solutions for patient-centred drug delivery devices that enhance dosing,...

Steriline’s Advanced Filling Innovations Exhibited At Interphex 2025

New York City, March 25, 2025 – Steriline, a well-established European manufacturer...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back