Drospirenone; ethinyl estradiol - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for drospirenone; ethinyl estradiol and what is the scope of patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for drospirenone; ethinyl estradiol

US Patents:	2
Tradenames:	16
Applicants:	16
NDAs:	33
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	35
Patent Applications:	1,428
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for drospirenone; ethinyl estradiol
DailyMed Link:	drospirenone; ethinyl estradiol at DailyMed

Recent Clinical Trials for drospirenone; ethinyl estradiol

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	Phase 1

See all drospirenone; ethinyl estradiol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; ethinyl estradiol

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YAZ	Tablets	drospirenone; ethinyl estradiol	3 mg/0.02 mg	021676	1	2006-09-29
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for drospirenone; ethinyl estradiol

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	205876-001	Sep 21, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	090081-001	Sep 7, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	KEMEYA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202138-001	Mar 13, 2019		DISCN	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

Expired US Patents for drospirenone; ethinyl estradiol

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.