LEVONORGESTREL AND ETHINYL ESTRADIOL Drug Patent Profile

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Levonorgestrel And Ethinyl Estradiol is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Watson Labs, Xiromed, Barr, Dr Reddys Labs Sa, Hetero Labs, and Naari Pte Ltd. and is included in twenty-nine NDAs.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

US Patents:	0
Applicants:	9
NDAs:	29
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	60
What excipients (inactive ingredients) are in LEVONORGESTREL AND ETHINYL ESTRADIOL?	LEVONORGESTREL AND ETHINYL ESTRADIOL excipients list
DailyMed Link:	LEVONORGESTREL AND ETHINYL ESTRADIOL at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
FHI 360	N/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A

Drug Class	Estrogen Progestin Progestin-containing Intrauterine Device Progestin-containing Intrauterine System
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	205131-001	Dec 14, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200492-001	May 27, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203871-001	Nov 13, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Naari Pte Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	207033-001	Oct 9, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	078834-001	May 31, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200490-001	Apr 21, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration