Felimazole Patent Expiration

Felimazole Petitions

Details of Felimazole's suitability petitions are listed below.

Petitioner	Action	Date of Action	Description

Felix Pharmaceuticals Pvt. Ltd.	Approved	20 Jan, 2022	The proposed change is for an oral solution ; the RLNAD is approved as unscored, coated tablets in 2.5 mg and 5 mg tablet strengths.
e5 Pharma, LLC	Denied	02 Nov, 2018	The proposed change was in dosage form. The petitioner proposed a rapidly-disintegrating tablet; the RLNAD is approved as coated tablets. The petitioner was issued a denial letter dated June 10, 2016.
Norbrook Laboratories, Ltd.	Approved	12 Oct, 2018	The proposed change is for an oral solution ; the RLNAD is approved as coated tablets in 2.5 mg and 5 mg tablet strengths.
e5 Pharma, LLC.	Denied	08 Jun, 2016	The proposed change is in dosage form. The RLNAD is approved as a coated tablet. The proposed change is for a rapidly disintigrating tablet.
e5 Pharma, LLC.	Approved	13 Jan, 2015	The generic product will differ in dosage form. The RLNAD is approved as a film-coated tablet. The proposed dosage form is an oral solution.
e5 Pharma, LLC.	Approved	26 Aug, 2014	The generic product will differ in dosage form. The RLNAD is approved as a film-coated tablet. The proposed dosage form is a soft chewable tablet.

Felimazole is a drug owned by DECHRA, LTD. Felimazole uses Methimazole as the active ingredient.