DELESTROGEN Drug Patent Profile

When do Delestrogen patents expire, and when can generic versions of Delestrogen launch?

Delestrogen is a drug marketed by Ph Health and is included in one NDA.

The generic ingredient in DELESTROGEN is estradiol valerate. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Delestrogen

A generic version of DELESTROGEN was approved as estradiol valerate by AM REGENT on January 19^th, 2010.

Summary for DELESTROGEN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DELESTROGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-002	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes
Ph Health	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-004	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes
Ph Health	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

DELESTROGEN (estradiol enanthate) Investment Scenario and Patent-Driven Exclusivity Fundamentals

Last updated: July 27, 2026

Executive summary

• Delestrogen is an injectable estradiol enanthate therapy with U.S. brand exposure tied to Orange Book-listed patents and remaining regulatory exclusivity (if any), plus practical constraints from manufacturing, labeling, and controlled distribution typical of estrogen injectables.
• The investment case is primarily driven by (1) how much patent life remains for Delestrogen’s Orange Book listings (composition, formulation, and method-of-use) and (2) whether ANDA/Section 505(b)(2) or 3rd-party label-to-label pathways can enter without infringement risk.
• Without the specific Orange Book record, NDA/Applicant identifiers, listed patent numbers, and FDA approval date(s), a complete, decision-grade investment model for Delestrogen cannot be produced.