LO MINASTRIN FE Drug Patent Profile

When do Lo Minastrin Fe patents expire, and when can generic versions of Lo Minastrin Fe launch?

Lo Minastrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in LO MINASTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lo Minastrin Fe

There have been four patent litigation cases 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 is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LO MINASTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO MINASTRIN FE
DailyMed Link:	LO MINASTRIN FE at DailyMed

US Patents and Regulatory Information for LO MINASTRIN FE

LO MINASTRIN FE 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
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013		DISCN	Yes	No	7,704,984

Expired US Patents for LO MINASTRIN FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	5,552,394
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	6,667,050

International Patents for LO MINASTRIN FE

See the table below for patents covering LO MINASTRIN FE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
China	101189015	Extended estrogen dosing contraceptive regimen
China	104248639	Extended estrogen dosing contraceptive regimen

Supplementary Protection Certificates for LO MINASTRIN FE

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

Last updated: July 30, 2026

LO MINASTRIN FE market dynamics and financial trajectory (revenue, pricing, and exclusivity-driven risk)

Executive summary: LO MINASTRIN FE is an oral contraceptive product. The market is dominated by generic and low-cost competition across branded oral contraceptives, with financial outcomes driven less by patent-backed growth and more by payer coverage, wholesale pricing, channel inventory cycles, and discontinuation or relaunch decisions by manufacturers. Without product-specific FDA, Orange Book, NDC, and company revenue data tied to “LO MINASTRIN FE” in the sources provided, a complete, accurate financial trajectory by quarter, revenue pool, and exclusivity timing cannot be produced.

What is LO MINASTRIN FE and what commercial category does it sit in?

Direct answer: LO MINASTRIN FE is marketed as a combined oral contraceptive (COC) using an estrogen plus a progestin regimen with a pill schedule that typically includes iron supplementation in the “FE” branding for the placebo week.

How does the oral contraceptive category shape market dynamics?

Oral contraceptives compete in a structure dominated by:

• Rapid substitution from branded to generics within class.
• Formulary placement rules that bias toward lower net cost.
• Multi-source pricing pressure that compresses gross margin at the brand level.
• High payer and pharmacy benefit manager (PBM) sensitivity to rebates, dispensing fees, and tier status.

What are the key demand drivers for COCs like LO MINASTRIN FE?

• Segment mix: adolescent and commercial insured uptake trends.
• Persistence: continuation rates after first-line prescribing.
• Formulary and prior authorization policy.
• Safety and tolerability perceptions tied to specific progestin and dosing schedule.

What are the typical supply chain and channel factors?

• Wholesaler inventory management around contract pricing and rebate settlement.
• Pharmacy ordering patterns around automatic substitution laws.
• Distribution model shifts when manufacturers discontinue or relaunch SKUs/NDCs.

Who competes with LO MINASTRIN FE and how does competitive intensity affect pricing?

Direct answer: LO MINASTRIN FE’s practical competitive set is other low-dose combined oral contraceptives and their generics, including multiple NDCs within the same active ingredient and strength ranges.

What drives substitution versus switching within COCs?

• Patient switching friction is usually low for COCs.
• Physicians may prefer a known regimen, but payer tier changes drive switch rates.
• Net price is typically the determinant for formulary retention.

How does generic entry change the economics of branded COCs?

When generics become available:

• Brand volume often drops first, followed by net price concessions.
• Rebates increase or brands lose formulary position.
• Gross-to-net typically compresses because PBMs anchor to lowest-cost generics.

When does LO MINASTRIN FE face exclusivity or generic-competition inflection points?

Direct answer: A precise exclusivity and patent/Orange Book timeline cannot be provided from the information supplied in the prompt.

What exclusivity mechanisms usually matter for COC brands?

• Orange Book-listed patents tied to formulations, methods of use, or combination regimens.
• Regulatory exclusivities (NCE/505(b)(2), pediatric, orphan) are less common for classic contraceptive products since many have older approvals and generic pathways.

What are the typical inflection points in COC lifecycle?

• First significant generic approvals often trigger sustained price pressure rather than a single event.
• Later patent cliffs (formulation or method-of-use) can extend brand advantage only if they block key generic competitors.

What is the Orange Book status of LO MINASTRIN FE?

Direct answer: Orange Book status cannot be stated accurately without Orange Book listings (patent numbers, expiration dates, and relevant FDA application references) tied specifically to LO MINASTRIN FE.

Which Orange Book elements would determine market exclusivity?

• Drug substance and drug product patent families.
• Method-of-use claims (if listed) tied to specific dosing schedules or indications.
• “Carve-outs” where some generic competitors can launch while others wait on blocking patents.

How strong is the patent estate for LO MINASTRIN FE, and what does that mean commercially?

Direct answer: Patent strength and enforceability cannot be quantified without the specific patent list for LO MINASTRIN FE.

How patent strength typically maps to financial trajectory in oral contraceptives

• Strong blocking families can delay generic entry, sustaining gross margin and volume.
• Weak or easily designed-around claims accelerate substitution and drive revenue declines.
• For COCs, even “protected” brands usually face rapid competition once biosimilar-like substitution analogs exist, meaning financial trajectory often follows payer economics more than patent duration.

What generic entry risks exist for LO MINASTRIN FE?

Direct answer: Generic entry risks cannot be enumerated accurately without the product’s exact active ingredients, strength, dosage form, and associated FDA approval pathway plus current Orange Book blocking patents.

What Paragraph IV risk profile usually looks like for COCs

• If multiple ANDA holders file with Paragraph IV certifications, litigation tends to follow.
• Settlement terms often convert into design-arounds and delayed launches.

What does the LO MINASTRIN FE financial trajectory look like across channel and net price?

Direct answer: A complete financial trajectory cannot be produced without product-specific revenue, wholesale acquisition cost (WAC), net sales, rebate data, and NDC-level performance.

What can be concluded about the likely directionality in the category

For branded COCs that face generic competition:

• Unit volume generally declines over time as switching to generics accelerates.
• Net price erodes through rebate changes and contract re-pricing.
• Remaining growth usually comes from share shifts, contracting improvements, or discontinuation of competitive SKUs.

How does LO MINASTRIN FE compare with other low-dose combined oral contraceptives on market and economics?

Direct answer: A comparative market-and-revenue analysis requires NDC-level data for LO MINASTRIN FE and peer products to benchmark price, share, and formulary position.

What comparison metrics matter most

• Dispense volume by NDC (or equivalent drug ID).
• Net price and rebate rate proxies (gross-to-net).
• Payer formulary tiering and coverage breadth.
• Time since first generic entrant in each peer.

What litigation or settlement dynamics affect LO MINASTRIN FE competition?

Direct answer: Litigation impact cannot be assessed without a verified litigation record tied to LO MINASTRIN FE.

What types of disputes typically matter for branded contraceptives

• ANDA patent challenges involving Orange Book-listed patents.
• Settlement agreements setting launch dates or product design requirements.
• Injunction outcomes affecting near-term volume.

What is LO MINASTRIN FE’s FDA pathway and regulatory status profile?

Direct answer: Regulatory pathway and status cannot be specified accurately without the specific FDA application reference, approval history, and current label/NDC status.

Which regulatory facts drive market access

• Label stability and changes affecting substitutability.
• Post-approval manufacturing changes that can create supply disruptions.
• Coding and listing changes affecting pharmacy system substitution.

Key data table template for LO MINASTRIN FE (required to complete a defensible financial trajectory)

No product-specific data was provided in the prompt, so this table cannot be filled accurately.

Item	What to extract	Why it matters for financial trajectory
Exact NDCs for LO MINASTRIN FE	NDC list by strength and pack	Volume and net sales are NDC-specific
FDA approval type	NDA / ANDA / 505(b)(2), supplement history	Predicts patent and generic pathways
Orange Book patents	Patent numbers, expiration dates, patent type	Determines generic launch timing
Litigation docket	Case numbers, dates, settlement terms	Captures legal delays and launch shifts
WAC and AMP over time	Pricing history	Shows gross erosion and rebate changes
Net sales by quarter	Company reporting	Shows financial trajectory and inflection points
PBM contract status	Tier placement changes	Explains volume shifts even without exclusivity cliffs

Key Takeaways

• LO MINASTRIN FE operates in a combined oral contraceptive market where pricing and revenue trajectories are dominated by generic substitution, payer contracting, and rebate/net-price dynamics.
• A precise exclusivity, Orange Book, litigation, and financial trajectory analysis cannot be completed from the information present in the prompt.
• To produce a defensible trajectory, the analysis must anchor on LO MINASTRIN FE’s exact NDCs, FDA approval reference, Orange Book patent list, and product-level revenue/price history.

FAQs

1. How do PBMs determine formulary tiering for branded oral contraceptives like LO MINASTRIN FE?
2. What drives net price erosion for oral contraceptives after generic launches?
3. What Orange Book patent categories most often delay generic entry for branded contraceptives?
4. How do settlement agreements in ANDA challenges affect the timing of generic availability for COCs?
5. Which NDC-level indicators best predict whether a COC brand will lose share versus maintain it?

References

1. Not available from the prompt.