Is there a generic for Norgestrel?

The FDA Orange Book does not currently list an approved generic (ANDA) for Norgestrel. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Norgestrel?

OPILL (NDA 017031, LABORATOIRE HRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Does Norgestrel have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Norgestrel. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Norgestrel are approved?

Norgestrel is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Norgestrel

Norgestrel: 1 brand, 0 generics.

Brand only1 exclusivity period

Generic status & protection

Marketing exclusivity runs through Jul 13, 2026.

Latest exclusivity ends Jul 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

OPILLRLDRS

LABORATOIRE HRANDA 017031—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.075MG	TABLET	ORAL	OTC	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

RTOExclusivity for a product moved over-the-counter
Jul 13, 2026
in 11 d

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Norgestrel — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo