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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Dow
AstraZeneca
Harvard Business School
Colorcon

Last Updated: May 24, 2022

Regulatory Exclusivity: NEW STRENGTH


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Drugs with New Strength Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Bausch And Lomb Inc LOTEMAX SM loteprednol etabonate GEL;OPHTHALMIC 208219-001 Feb 22, 2019 RX Yes Yes See Plans and Pricing NEW STRENGTH
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No See Plans and Pricing NEW STRENGTH
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-003 Aug 12, 2019 RX Yes No See Plans and Pricing NEW STRENGTH
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Moodys
Mallinckrodt
AstraZeneca
McKinsey

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