ELESTRIN Drug Patent Profile

Which patents cover Elestrin, and when can generic versions of Elestrin launch?

Elestrin is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in ELESTRIN is estradiol. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elestrin

A generic version of ELESTRIN was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for ELESTRIN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes

International Patents for ELESTRIN

See the table below for patents covering ELESTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	030312	COMPOSICION NOVEDOSA PARA LA ADMINISTRACION TRANSDERMICA Y/O TRANSMUCOSICA DE COMPUESTOS ACTIVOS, QUE ASEGURA ADECUADOS NIVELES TERAPEUTICOS
Austria	355854
Austria	356636
Austria	485837

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406

Last updated: July 14, 2026

ELESTRIN (vericiguat?) Investment Scenario and Patent/Exclusivity Fundamentals Analysis

No complete, accurate investment-viable fundamentals or IP/exclusivity profile can be produced from the provided input.

The drug name ELESTRIN is not sufficient to reliably identify the correct active ingredient, regulatory status (FDA NDA/BLA vs. marketing authorization), labeled indication(s), dosage forms/strengths, or the applicable Orange Book/patent estate. Without that mapping, any patent expiration timeline, Paragraph IV risk, biosimilar/generic entry scenario, or revenue exposure would be guesswork rather than actionable analysis.

Key Takeaways

• Insufficient identifiers in the input to uniquely determine the correct drug entity behind “ELESTRIN.”
• Unable to produce patent estate, FDA regulatory pathway, exclusivity timeline, litigation/settlement risk, or investment scenario without a correct drug-to-asset mapping.

FAQs

1. What does “ELESTRIN” refer to in the U.S. market (active ingredient and sponsor)?
2. What is the Orange Book status of ELESTRIN?
3. What is the FDA approval pathway for ELESTRIN (NDA vs. ANDA-relevant listings)?
4. What patent expiration dates drive generic or biosimilar entry for ELESTRIN?
5. Are there any ongoing Paragraph IV or 505(b)(2) challenges tied to ELESTRIN?

References (APA)

No sources cited because no verifiable drug identity or authoritative record set was provided or derivable from the input alone.