AYGESTIN Drug Patent Profile

Which patents cover Aygestin, and what generic alternatives are available?

Aygestin is a drug marketed by Duramed Res and is included in one NDA.

The generic ingredient in AYGESTIN is norethindrone acetate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the norethindrone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aygestin

A generic version of AYGESTIN was approved as norethindrone acetate by BARR on May 25^th, 2001.

Summary for AYGESTIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
DailyMed Link:	AYGESTIN at DailyMed

Recent Clinical Trials for AYGESTIN

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

Sponsor	Phase
Norton Healthcare	N/A
Scott and White Hospital & Clinic	Phase 4
Brigham and Women's Hospital	Phase 2

See all AYGESTIN clinical trials

US Patents and Regulatory Information for AYGESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duramed Res	AYGESTIN	norethindrone acetate	TABLET;ORAL	018405-001	Apr 21, 1982		DISCN	Yes	No

Last updated: June 10, 2026

AYGESTIN (norethisterone acetate) market dynamics and financial trajectory: exclusivity, competition, and revenue risk

AYGESTIN is a legacy oral progestin (norethisterone acetate) marketed in branded form in multiple geographies for indications including abnormal uterine bleeding, endometriosis, and menstrual disorders. The financial trajectory is dominated by patent and exclusivity dilution versus rapid generic penetration typical for mature small-molecule progestins, with upside limited by: (1) continued branded differentiation via payer positioning and formulary access and (2) country-specific reimbursement and dispensing dynamics. The principal downside is brand-to-generic substitution once pricing pressure accelerates, with additional erosion if multiple ANDAs launch in parallel.

No complete dataset for the drug’s current global sales, segment revenue, geography-specific pricing history, OR Orange Book patent listings, FDA regulatory milestones, or live litigation/settlement terms is provided in the prompt. Without those inputs, a complete and accurate financial trajectory cannot be constructed.

If you require a full, decision-grade market and financial profile (revenue trend, shipment volume, ASP, payer/plan share, generic launch timing, and patent-based risk schedule), only proceed when complete factual inputs are supplied.