Viewing data from:

BALCOLTRA

NDA

ETHINYL ESTRADIOL; LEVONORGESTREL | N208612 | AVION PHARMACEUTICALS LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

7838042

Jun. 1, 2027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Avion Pharmaceuticals, LLC et al v. Lupin Limited et al 1:2022cv00729	D. Del.	2022-06-02	Terminated 2024-01-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

44 trials from ClinicalTrials.gov — 1 recruiting, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies NCT03557619	Phase 1	Recruiting	AbbVie	12	2019-07-30 → 2026-03-21
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale NCT00394771	Phase 2	Completed	Duramed Research	567	2006-10 → 2008-03
Hormonal Birth Control and the Risk of Acquiring HIV NCT00006324	N/A	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6,360	1999-12 → 2002-12
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females NCT00254800	Phase 1	Completed	AstraZeneca	38	2005-11 → 2006-08
Oral Contraceptive Efficacy and Body Weight NCT00662454	Phase 4	Completed	Oregon Health and Science University	120	2006-01 → 2006-05
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol NCT03547024	Phase 1	Completed	Janssen-Cilag International NV	14	2018-06-08 → 2018-08-30
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel NCT03359057	Phase 3	Completed	Galeno Desenvolvimento de Pesquisas Clínicas	36	2013-02-26 → 2013-09-17
Human Ovarian Follicular Dynamics and Emergency Contraception NCT00204451	Phase 4	Completed	University of Saskatchewan	40	2005-07 → 2006-06
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive NCT00213096	Phase 2	Completed	Population Council	50	2003-03 → 2004-02
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids NCT04267250	Phase 1	Completed	Pfizer	18	2020-08-24 → 2020-11-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$10.04

per ea

Lowest NADAC/Unit

$3.74

per ea

Brand NDCs

Generic NDCs

Avg Brand: $10.04

Avg Generic: $3.74

63% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
75854060203BALCOLTRA TABLET	$10.04	EA	Brand	$3.74	2026-01-01
75854060228BALCOLTRA TABLET	$10.04	EA	Brand	$3.74	2026-01-01
42192062303LEVONORGESTREL-ETH ESTRADIOL-FE BISGLYC 0.1-0.02-36.5 MG TAB	$3.74	EA	Generic	—	2026-06-17
42192062328LEVONORGESTREL-ETH ESTRADIOL-FE BISGLYC 0.1-0.02-36.5 MG TAB	$3.74	EA	Generic	—	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

$147.18

Highest Price

$711.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42192-0623-03LEVONORGEST-ETH.ESTRADIOL-IRON	$585.68	FSS	Avion Pharmaceuticals, LLC	12/31/2026
42192-0623-03LEVONORGEST-ETH.ESTRADIOL-IRON	$147.18	Big4	Avion Pharmaceuticals, LLC	12/31/2026
75854-0602-03BALCOLTRA TAB,28	$711.25	FSS	Avion Pharmaceuticals, LLC	12/31/2026
75854-0602-03BALCOLTRA TAB,28	$537.73	Big4	Avion Pharmaceuticals, LLC	12/31/2026

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

Medicare Part D Spending

CMS annual spending data for Balcoltra (2024)

Total Spending

$15K

Total Claims

Beneficiaries

Avg Cost/Unit

$9.46

Spending Trend

$13K(2020)→$33K(2021)→$43K(2022)→$39K(2023)→$15K(2024)

YoY Change:-1.7%

5yr CAGR:+6.5%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 3, 2022	SUPPL -5	View Letter (PDF)
Jan 11, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.02MG;0.1MG

RLDAB3

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jan 9, 2018

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7838042	Jun 1, 2027	—	Yes	—		—