Viewing data from:

OPILL

NDA

NORGESTREL | N017031 | LABORATOIRE HRA PHARMA

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

RTO

Jul. 13, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill NCT03585712	Phase 2	Completed	HRA Pharma	52	2018-07-24 → 2020-04-07
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use NCT04112095	Phase 3	Completed	HRA Pharma	962	2019-09-06 → 2021-08-05
Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer NCT00445887	Phase 2	Completed	Gynecologic Oncology Group	60	2008-03-10
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer NCT00033358	Phase 2	Completed	National Cancer Institute (NCI)	52	2002-02
A Study of Oral Contraception Under Simulated OTC Conditions NCT03559010	Phase 3	Terminated	HRA Pharma	189	2018-04-27 → 2018-11-14

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.5984

per ea

Lowest NADAC/Unit

$0.4997

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00113810101OPILL 0.075 MG TABLET	$0.5984	EA	Brand	—	2026-06-17
00113810103OPILL 0.075 MG TABLET	$0.4997	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$15.51

Highest Price

$38.79

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00113-8101-01NORGESTREL 75MCG TAB,28	$15.51	FSS	Perrigo Direct	09/14/2028
00113-8101-03NORGESTREL 75MCG TAB,28	$38.79	FSS	Perrigo Direct	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

GEDEON RICHTER PLCNORGESTREL USP

DMF 91361991

BAYER AGNORGESTREL

DMF 173072004

LUPIN LTDNORGESTREL USP

DMF 236122011

GEDEON RICHTER PLCNORGESTREL USP

DMF 354192020

STERLING SPANORGESTREL

DMF 413242025

HUNAN KYF PHARMACEUTICAL CO LTDNORGESTREL

DMF 414662025

SCINOPHARM TAIWAN LTDInactiveNORGESTREL USP

DMF 170682003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Sep 26, 2025	SUPPL -44	View Letter (PDF)
Jul 13, 2023	SUPPL -41	View Letter (PDF)
Aug 29, 2017	SUPPL -36	View Letter (PDF)
Aug 29, 2017	SUPPL -35	View Letter (PDF)
Jul 21, 2004	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.075MG

RLD

0 patents1 exclusivity▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

Exclusivities (1)

Code	Date	Status
RTO	Jul 13, 2026	Expired