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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Medtronic
AstraZeneca
Merck
Moodys

Last Updated: November 16, 2019

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Regulatory Exclusivity: PATENT CHALLENGE

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Drugs with Patent Challenge Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Mylan TADALAFIL tadalafil TABLET;ORAL 200630-001 Aug 3, 2018 AB2 RX No No   Start Trial PATENT CHALLENGE
Accord Hlthcare DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863-001 Jul 11, 2018 AB RX No No   Start Trial PATENT CHALLENGE
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 AA RX No No   Start Trial PATENT CHALLENGE
Teva Pharms Usa TADALAFIL tadalafil TABLET;ORAL 090141-003 May 22, 2018 AB RX No No   Start Trial PATENT CHALLENGE
>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:

Mallinckrodt
Boehringer Ingelheim
Moodys
Baxter
AstraZeneca
Medtronic

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