Viewing data from:

COMBIPATCH

NDA

ESTRADIOL; NORETHINDRONE ACETATE | N020870 | NOVEN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

35 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism NCT00004763	Phase 2	Completed	National Center for Research Resources (NCRR)	45	1993-01
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions NCT01340625	Phase 1	Completed	Teva Pharmaceuticals USA	36	2006-12 → 2007-01
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers NCT03856970	Phase 1	Completed	Ironwood Pharmaceuticals, Inc.	87	2019-03-11 → 2019-07-03
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions NCT01181726	Phase 1	Completed	Teva Pharmaceuticals USA	40	2007-01 → 2007-02
A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists NCT01209143	Phase 1	Completed	Genentech, Inc.	52	2010-11 → 2012-03
Ovulation Incidence in Oral Contraceptive Users NCT03106454	Phase 3	Completed	University of Southern California	58	2014-08 → 2024-01-01
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women NCT02654054	Phase 3	Completed	AbbVie	413	2015-12-22 → 2018-12-12
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive NCT01040845	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	30	2007-08 → 2008-02
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 NCT02103569	Phase 1	Completed	Bristol-Myers Squibb	20	2014-04 → 2014-07
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain NCT03654274	Phase 3	Completed	Myovant Sciences GmbH	802	2018-05-22 → 2023-01-31

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

$31.82

per ea

Lowest NADAC/Unit

$31.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68968052508COMBIPATCH 0.05-0.25 MG PTCH	$31.82	EA	Brand	—	2026-06-17
68968051408COMBIPATCH 0.05-0.14 MG PTCH	$31.82	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$126.75

Highest Price

$126.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68968-0514-08COMBIPATCH 0.05MG/0.14MG/DAY	$126.75	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0514-08COMBIPATCH 0.05MG/0.14MG/DAY	$126.75	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0525-08COMBIPATCH 0.05MG/0.25MG/DAY	$126.75	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0525-08COMBIPATCH 0.05MG/0.25MG/DAY	$126.75	Big4	Noven Therapeutics, LLC	10/14/2026

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

Medicare Part D Spending

CMS annual spending data for Combipatch (2024)

Total Spending

$5.4M

Total Claims

13,387

Beneficiaries

3,709

Avg Cost/Unit

$29.89

Spending Trend

$3.1M(2019)→$3.4M(2020)→$3.9M(2021)→$4.2M(2022)→$4.7M(2023)→$5.4M(2024)

YoY Change:-2.9%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -33	View Letter (PDF)
May 11, 2015	SUPPL -19	View Letter (PDF)
Sep 20, 2013	SUPPL -17	View Letter (PDF)
Nov 18, 2005	SUPPL -15	View Letter (PDF)
Jan 18, 2005	SUPPL -13	View Letter (PDF)
Jun 23, 2004	SUPPL -10	View Letter (PDF)
Aug 7, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.05MG/24HR;0.14MG/24HR

RLD

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Aug 7, 1998

No patent or exclusivity listings for this strength.

#002 — 0.05MG/24HR;0.25MG/24HR

RLD

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Aug 7, 1998