Is Opill still available?

Yes. Opill (NDA 017031) is listed with marketing status Over-the-counter in the FDA Orange Book.

Does Opill have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Opill's active ingredient (Norgestrel).

Does Opill have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Opill. Exclusivity can delay generic approval independently of any listed patents.

What is Opill's FDA application number?

Opill is approved under NDA 017031, held by Laboratoire Hra.

Orange Book product · Brand (NDA)

Opill

Norgestrel

Brand (NDA)NDA 017031RLD Laboratoire Hra

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Opill (Norgestrel) is Laboratoire Hra's brand-name drug, approved by the FDA under NDA 017031. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 1 marketing-exclusivity period is recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Today
Exclusivity ends · RTO
Exclusivity for a product moved over-the-counter
Jul 13, 2026
in 11 d

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

NORGESTREL

Strength

0.075MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 017031

Product number

001

Marketing status

Over-the-counter

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Norgestrel family

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.

Opill — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Norgestrel active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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