BALCOLTRA Drug Patent Profile

Which patents cover Balcoltra, and when can generic versions of Balcoltra launch?

Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Balcoltra

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BALCOLTRA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for BALCOLTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALCOLTRA
What excipients (inactive ingredients) are in BALCOLTRA?	BALCOLTRA excipients list
DailyMed Link:	BALCOLTRA at DailyMed

See drug prices for BALCOLTRA

Paragraph IV (Patent) Challenges for BALCOLTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14

US Patents and Regulatory Information for BALCOLTRA

BALCOLTRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	AB3	RX	Yes	Yes				Y

Expired US Patents for BALCOLTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018

International Patents for BALCOLTRA

See the table below for patents covering BALCOLTRA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002331603
Brazil	0212399
Canada	2457584	AMELIORATION DE LA SOLUBILITE DES CHELATES D'ACIDES AMINES DE FER ET DES PROTEINATES DE FER (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES)
China	1264428
China	1555228
Spain	2303739	AUMENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS CON HIERRO Y PROTEINATOS DE HIERRO.
United Kingdom	0403792

Supplementary Protection Certificates for BALCOLTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

BALCOLTRA Market Dynamics and Financial Trajectory: Demand Drivers, Pricing, Competitive Pressure, and Revenue Outlook

Last updated: June 8, 2026

Executive summary BALCOLTRA (levonorgestrel and ethinyl estradiol with ferrous fumarate) is an oral contraceptive tied to long-run demand stability, inventory-cycle pricing, and generic substitution dynamics. Financial trajectory is largely determined by (1) formulary access at large pharmacy benefit managers and plans, (2) class-level switching from competitor OCs, (3) gross-to-net pressure from rebates and patient savings programs, and (4) competitive entries in the same strength and dosing cadence (21 active/7 ferrous, or equivalent regimens in the same “OC+iron” category). Near-term revenue performance typically tracks script volumes and adherence, while medium-term durability hinges on how quickly label-protecting IP and any 505(b)(2)/ANDA competitors compress price and margins.

What is BALCOLTRA and what market does it compete in?

BALCOLTRA is positioned in the combined oral contraceptive (COC) market with iron supplementation. The relevant competitive set is not a single product but the OTC-to-plan-treated “COC plus iron” and closely substitutable COC classes.

How do COCs with iron affect demand?

Iron-containing COCs (COC+iron) tend to:

• Maintain demand among patients and clinicians seeking iron supplementation with adherence support.
• Compete on perceived “complete regimen” value rather than on pharmacologic superiority, since clinical differentiation is usually limited in claims accepted by payers.
• Face substitution behavior at the pharmacy counter toward equivalent dosing and covered NDCs, especially when rebates favor low net-cost options.

What buyers and channels matter?

• Retail pharmacy is the primary volume engine.
• Specialty channels are not relevant (typical COC logistics).
• PBM formularies and plan design (tier placement, preferred brand status, prior authorization rules) drive market share shifts.

Which financial KPIs predict BALCOLTRA revenue trajectory?

For an oral contraceptive, revenue movement is usually script-volume driven with meaningful gross-to-net pressure.

The KPIs that typically move first

1. Prescriptions (TRx) and new starts
2. Refill adherence (30- and 90-day persistence)
3. Net price realization after rebates and coupon programs
4. Share of prescriptions by formulary tier (preferred vs non-preferred)
5. Patient out-of-pocket (copay support effectiveness)
6. Pharmacy inventory cycles and wholesaler fill patterns

What does “gross-to-net” mean for BALCOLTRA economics?

COCs often show:

• High rebate intensity relative to list price because of competition and PBM contracting.
• Net price compression when preferred brand status is lost or when generics expand within the same regimen.
• Coupon effectiveness can help protect net revenues for a period, but it frequently transfers cost from brand price to patient assistance and PBM economics.

What are the key market dynamics shaping BALCOLTRA demand?

BALCOLTRA’s demand profile is influenced by broad women’s health utilization and by payer-driven substitution.

Class-level demand stability vs switching

• COC utilization is relatively stable long-term, with seasonal buying patterns and sensitivity to patient behavior.
• Switching is triggered by formulary updates, changes in covered NDC status, step therapy, and pricing competitiveness.
• Brand share often declines when multiple equivalents appear and when PBM incentives favor the lowest net-cost option.

Formulary design: the dominant variable

• Preferred formulary placement can hold share even with generic competition.
• Non-preferred tier placement tends to accelerate displacement.
• Plan design changes can produce fast market share shifts, even when total class demand is unchanged.

Competitive substitution mechanics

COC+iron products compete on:

• Equivalent dosing and regimen schedule (active and iron days)
• Covered NDC availability and PBM rebate structure
• Perceived patient fit by prescribing habits and pharmacist counseling

How does generic entry risk typically affect BALCOLTRA revenue?

For COCs, “generic entry risk” is less about one entrant and more about incremental erosion as more covered SKUs appear in the same substitution neighborhood.

What drives revenue compression?

• Net price falls first through contracting and rebate re-optimization.
• Script share follows with pharmacy-level switching at refill time.
• Patient assistance can slow declines but usually does not reverse long-term share loss when preferred coverage shifts.

Time-to-impact patterns

• Short-term: plan and PBM contracting renegotiation can change net price quickly.
• Medium-term: prescription mix shifts over multiple refill cycles as prescribers and patients adopt alternative covered options.

What pricing and net realization trends should be expected in this segment?

COCs exhibit recurring industry behavior:

• List price is often less predictive than negotiated net price.
• Wholesale inventory and channel demand management can temporarily shift revenue timing.
• Net revenue is sensitive to rebate rates, which tend to rise during competitive pressure to preserve demand.

How patient affordability programs change revenue math

• Coupons and copay assistance can increase fill rates but reduce net price through added payer and manufacturer cost.
• Over time, PBMs can counter through greater rebate capture and tier movement.

What role do payer negotiations and PBM contracting play?

For BALCOLTRA, PBM contracting is typically the highest-leverage determinant of:

• Effective net price
• Formulary inclusion and preferred status
• Switching velocity when competing alternatives are priced lower on net terms

Common contracting outcomes

• Preferred placement with a mid-level rebate if differentiation is accepted.
• Non-preferred placement with a larger rebate to maintain limited access.
• “Formulary carve” toward lowest net cost, accelerating displacement if multiple entrants exist.

What competitive landscape matters most for BALCOLTRA?

Competition is dominated by:

• COC brands and authorized generics
• Multi-source ANDAs and “therapeutic equivalent” substitutes with similar regimen schedules
• Close regimen alternatives without iron or with equivalent iron delivery, depending on payer policy

Where share loss usually occurs

• At chain pharmacies during NDC-level switching for covered cost.
• At plan switching cycles when formulary rules update for the next coverage year.

What is the likely financial trajectory: bull, base, and bear paths?

BALCOLTRA financial trajectory should be modeled as volume and net-price scenarios.

Base-case trajectory (typical for stable COC franchises)

• Modest unit growth or stable TRx, with gradual share erosion if additional covered substitutes expand.
• Net price declines modestly with competitive rebate increases.
• Operating margin stabilizes if manufacturing and selling costs scale with volumes.

Bear-case trajectory (formulary loss or rapid net erosion)

• Loss of preferred status or increased tier restrictions.
• Faster script share decline due to pharmacy switching.
• Material net price compression from rebate escalation and reduced patient assistance effectiveness.
• Revenue drop accelerates over 2 to 4 quarters as refills roll over.

Bull-case trajectory (durable preferred coverage)

• Continued preferred placement with controlled rebate intensity.
• Patient assistance and contracting preserve pharmacy fill rates.
• Revenue stabilizes or grows at low single-digit rates if class demand expands slightly.

What about IP and exclusivity: does it still matter for BALCOLTRA revenue?

For many COCs, financial performance after launch depends more on formulary and genericization than on patent protection. Patent landscape impacts entry timing and can slow displacement if unique formulation or method-of-use protections exist, but in the COC category, substitution pressure is usually determined by what is covered and how quickly equivalents are adopted.

What FDA and regulatory status affects commercialization?

For an approved COC product, FDA status impacts:

• Availability of generics and 505(b)(2)/ANDA entrants that can substitute.
• Label equivalence considerations in payer policies.
• Label-driven differentiation claims that might influence prescriber preference.

Key commercial risk factors specific to BALCOLTRA

1. Formulary tier downgrade or loss of preferred coverage
2. Higher net discounting by competitors to capture incremental plan slots
3. Rapid NDC-level substitution once payer coverage favors lower net cost
4. Rebates and patient programs rising faster than unit volume
5. Channel inventory movements that alter revenue timing

Key tailwinds

1. Ongoing COC class demand stability and patient adherence cycles
2. Potential contracting strategies that preserve preferred access
3. Patient-facing affordability programs that slow fill-rate erosion
4. Prescriber inertia in ongoing users and refill behavior

Key Takeaways

• BALCOLTRA financial performance is script-volume and net-price driven, not market expansion dependent.
• The dominant market dynamic is formulary contracting and pharmacy switching inside the COC+iron substitution set.
• Revenue durability is most likely if preferred coverage persists and rebate intensity remains controlled.
• Generic and multi-source competitive pressure typically compresses net price first, then share follows over refill cycles.
• The most material risk is a payer-driven loss of preferred status that accelerates both net revenue compression and unit displacement.

FAQs

1) What causes abrupt month-to-month revenue changes for oral contraceptives like BALCOLTRA?
Formulary updates, PBM contracting cycles, and pharmacy NDC switching typically create visible step-changes after refill rollovers and wholesaler ordering adjustments.

2) Does BALCOLTRA compete more on clinical differentiation or on formulary economics?
COCs in this category generally compete primarily on formulary economics, covered NDC availability, and negotiated rebates rather than on distinct clinical differentiation.

3) When generics enter, what happens first: price compression or volume loss?
Net price compression usually occurs first through rebate and contract renegotiation, with volume loss following as prescriptions switch across refill cycles.

4) How do patient assistance programs influence long-term share for BALCOLTRA?
They can slow displacement near-term by reducing patient barriers, but payers can counter through stronger rebate capture and tier moves that accelerate substitution over time.

5) What is the most important metric to monitor for BALCOLTRA competitive risk?
Share of prescriptions at covered NDC level across key PBMs and plans, paired with net price realization after rebates and discounts.

References

1. APA: Data sources are not provided in the input.