LOESTRIN 24 FE Drug Patent Profile

Which patents cover Loestrin 24 Fe, and when can generic versions of Loestrin 24 Fe launch?

Loestrin 24 Fe is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in LOESTRIN 24 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.

Summary for LOESTRIN 24 FE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	8
Patent Applications:	206
What excipients (inactive ingredients) are in LOESTRIN 24 FE?	LOESTRIN 24 FE excipients list
DailyMed Link:	LOESTRIN 24 FE at DailyMed

Recent Clinical Trials for LOESTRIN 24 FE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ViiV Healthcare	PHASE1
Bristol-Myers Squibb	Phase 1
Eisai Inc.	Phase 1

See all LOESTRIN 24 FE clinical trials

US Patents and Regulatory Information for LOESTRIN 24 FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	LOESTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021871-001	Feb 17, 2006		DISCN	Yes	No

Expired US Patents for LOESTRIN 24 FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOESTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021871-001	Feb 17, 2006

Loestrin 24 Fe Market Dynamics, Patent Expiration, Generic Entry, and Financial Trajectory

Last updated: August 2, 2026

Loestrin 24 Fe is a combined oral contraceptive containing norethindrone acetate 1 mg and ethinyl estradiol 20 mcg, with ferrous fumarate tablets included in the 28-day regimen. Warner Chilcott commercialized the product before its acquisition by Actavis in 2013. The brand generated substantial women’s-health revenue before generic competition sharply reduced its commercial value. Its market has since shifted from branded sales to multiple ANDA-approved generic products.

What is Loestrin 24 Fe and how does it compare with competing contraceptives?

Loestrin 24 Fe uses 24 hormone-containing tablets followed by four nonhormonal ferrous fumarate tablets. The regimen is designed to produce a shorter hormone-free interval than conventional 21-day oral contraceptives.

Product	Active ingredients	Hormone schedule	Commercial position
Loestrin 24 Fe	Norethindrone acetate and ethinyl estradiol	24 active, 4 iron tablets	Original branded product
Loestrin Fe 1/20 generic equivalents	Norethindrone acetate and ethinyl estradiol	Generally 24 active, 4 inert or iron tablets	Low-price generic market
Loestrin 1/20	Norethindrone acetate and ethinyl estradiol	21 active tablets	Earlier related formulation
Yaz	Drospirenone and ethinyl estradiol	24 active, 4 inert tablets	Competing branded oral contraceptive
Generess Fe	Norethindrone and ethinyl estradiol	Chewable formulation	Alternative delivery format
Seasonique and similar products	Levonorgestrel and ethinyl estradiol	Extended-cycle dosing	Competes on reduced withdrawal bleeding

The key commercial distinction was the 24-day active-pill schedule combined with a low-dose estrogen formulation. The product did not have the biological complexity of a biologic drug and did not require biosimilar development.

When did the FDA approve Loestrin 24 Fe?

The FDA approved Loestrin 24 Fe in 2006 under NDA 021871. Warner Chilcott was the original sponsor identified in the product’s FDA regulatory record. The product combined established active pharmaceutical ingredients in a defined 24/4 regimen, so its regulatory protection was driven primarily by formulation and patent rights rather than new-chemical-entity exclusivity.[1]

The FDA label identifies the active ingredients as:

• Norethindrone acetate, 1 mg
• Ethinyl estradiol, 20 mcg
• Ferrous fumarate, 75 mg in the reminder tablets

The ferrous fumarate tablets are nonhormonal reminder tablets. Their inclusion supports the 28-day packaging and regimen design but does not create a separate therapeutic exclusivity category.

What patents protected Loestrin 24 Fe?

The principal patent associated with Loestrin 24 Fe was U.S. Patent No. 6,667,050. The patent covered contraceptive pharmaceutical compositions involving norethindrone acetate and ethinyl estradiol and was listed in the FDA Orange Book for the product.[2]

Patent or regulatory right	Relevance to Loestrin 24 Fe	Approximate end of protection
U.S. Patent No. 6,667,050	Core composition and formulation protection	2020, subject to applicable term adjustments
FDA approval exclusivity	Post-approval regulatory protection	Expired before broad generic entry
Pediatric exclusivity	No material long-term barrier to generic competition	Not a durable post-2020 barrier

The product’s market protection did not depend on a permanent formulation monopoly. Once the relevant patent and regulatory barriers were overcome, ANDA applicants could compete with products demonstrating pharmaceutical equivalence and bioequivalence.

When did Loestrin 24 Fe lose exclusivity?

Loestrin 24 Fe lost practical exclusivity in the 2013-2014 period, when generic manufacturers obtained FDA approvals and commercial launches began. The patent estate remained relevant to settlement timing and launch rights, but it no longer supported a durable branded monopoly.

The competitive sequence was broadly:

Period	Market event	Commercial effect
2006	FDA approval of Loestrin 24 Fe	Warner Chilcott established the branded product
2010-2012	ANDA litigation and patent challenges developed	Generic launch timing became the central commercial issue
2013	Actavis acquired Warner Chilcott	Product ownership moved to Actavis
2013-2014	Generic approvals and authorized-generic activity	Brand pricing power weakened sharply
2020	Core listed patent term reached its endpoint	Remaining patent barrier largely disappeared
2020 onward	Multiple generic suppliers competed	Market shifted to commodity pricing

The decisive economic event was generic entry, not the formal expiration date alone. In oral contraceptives, pharmacy substitution can move volume rapidly once an approved generic is available.

Which companies challenged the Loestrin 24 Fe patent estate?

Generic manufacturers including Mylan and other ANDA applicants challenged the relevant Orange Book-listed protections through Paragraph IV certifications or related patent proceedings. These challenges alleged that the listed patent was invalid, unenforceable, or would not be infringed by the proposed generic products.

The litigation strategy was commercially significant because the first successful Paragraph IV applicant could obtain 180 days of generic exclusivity under the Hatch-Waxman framework. That period can create a temporary market advantage even when the long-term market outcome is full generic competition.

Publicly available litigation and company disclosures indicate that Loestrin-related patent disputes were part of the broader Warner Chilcott and Actavis generic-litigation portfolio. The disputes were resolved through agreements that permitted generic entry before the ultimate expiration of the listed patent, although the exact economic terms of individual settlements were not generally disclosed in public filings.[3][4]

What was the financial trajectory of Loestrin 24 Fe?

Loestrin 24 Fe was one of Warner Chilcott’s important women’s-health products before generic substitution. Its financial trajectory followed the standard branded-drug pattern:

1. Revenue expansion after launch and physician adoption.
2. Maturation as the product reached a large contraceptive patient base.
3. Price and volume pressure from anticipated ANDA competition.
4. Rapid erosion after generic availability.
5. Transition from branded revenue to residual and authorized-generic economics.

Warner Chilcott’s public filings reported Loestrin as part of its women’s-health portfolio and identified generic competition as a major risk to product revenue. After the Actavis acquisition, Actavis reported continuing erosion in legacy Warner Chilcott products as generic products entered the market.[3][4]

How did generic entry affect revenue?

Generic entry affected Loestrin 24 Fe through three channels:

• Pharmacy substitution reduced branded prescription volume.
• Generic price competition reduced net realized price.
• Payers increased formulary preference for lower-cost equivalents.

The brand could retain some demand through physician prescribing, patient familiarity, and managed-care coverage, but those factors were insufficient to preserve the pre-generic revenue base. The product’s active ingredients were well established, and manufacturing did not require a complex device, sterile process, or biologic production platform.

A standalone, current Loestrin 24 Fe revenue series is not reported by the present product owner in the same way that large protected brands are reported. After generic entry, the commercially relevant metric became the combined value of the brand, authorized generic, and any residual supply arrangements rather than branded Loestrin 24 Fe sales alone.

What is the Orange Book status of Loestrin 24 Fe?

The FDA Orange Book historically identified Loestrin 24 Fe under NDA 021871 and listed patent information supplied by the NDA holder. Orange Book status should be separated into three questions:

Issue	Loestrin 24 Fe position
Approved brand NDA	Yes
Small-molecule ANDA pathway	Yes
Biosimilar pathway	No
Historical listed patent	U.S. Patent No. 6,667,050
Current commercial exclusivity	No meaningful branded exclusivity
Generic substitution	Available through approved equivalent products, subject to state pharmacy rules

Orange Book listings can change as FDA records are updated, products are discontinued, or patent information is removed. The historical patent framework, however, explains the timing of generic competition and the product’s loss of pricing power.[2]

What formulations are protected by Loestrin 24 Fe patents?

The principal protection related to the hormonal composition and regimen rather than a difficult-to-reproduce delivery system. Relevant formulation attributes included:

• Low-dose ethinyl estradiol content
• Norethindrone acetate as the progestin
• A 24-day active-pill schedule
• Four nonhormonal reminder tablets
• Blister packaging and regimen presentation

The ferrous fumarate reminder tablets helped distinguish the branded product commercially, but generic applicants could generally design equivalent products using inert tablets or iron-containing tablets while satisfying FDA requirements for therapeutic equivalence and labeling.

Formulation protection was therefore narrower than the protection found in products with proprietary extended-release matrices, inhalation devices, transdermal systems, injectors, or complex biologic manufacturing processes.

Are there biosimilar risks for Loestrin 24 Fe?

No. Loestrin 24 Fe is a conventional small-molecule oral drug. The relevant competitive threat is generic ANDA competition, not biosimilar competition under the Public Health Service Act.

The product has:

• No biologic license application
• No interchangeable-biosimilar framework
• No reference-product exclusivity under the biologics statute
• No manufacturing barrier comparable to monoclonal antibodies or recombinant proteins

This distinction lowers development complexity for competitors and increases the probability of multiple suppliers after patent barriers fall.

Did licensing deals affect Loestrin 24 Fe?

The principal ownership transaction was Actavis’s acquisition of Warner Chilcott in 2013. The transaction transferred Warner Chilcott’s portfolio, including Loestrin 24 Fe, to Actavis.[4]

There is no widely reported licensing arrangement that created a separate long-term commercial moat around Loestrin 24 Fe. The product’s economics were driven by:

• Warner Chilcott’s original commercialization
• Actavis’s portfolio integration
• ANDA litigation
• Generic launch timing
• Pharmacy substitution
• Potential authorized-generic economics

The acquisition was strategically important because Actavis had an established generic business and could manage both branded and generic exposure. It also occurred as several Warner Chilcott products approached significant patent and generic risks.

What generic launch scenarios existed for Loestrin 24 Fe?

The practical launch scenarios were:

Scenario	Result
First generic launches after settlement	Temporary first-mover advantage and rapid share capture
Authorized generic launches alongside or near independent generic entry	Reduced value of third-party 180-day exclusivity
Multiple generic launches after patent expiry	Rapid price compression
Brand remains available without strong formulary support	Residual prescriptions but limited pricing power
Brand discontinuation or reduced promotion	Market becomes primarily generic

Actavis’s position as both a branded-product owner and a major generic manufacturer gave it the ability to participate in the post-exclusivity market through generic channels. That structure can preserve some product economics while accelerating the decline of the branded presentation.

How strong is the Loestrin 24 Fe patent estate?

The patent estate was commercially useful but not structurally strong by current specialty-pharmaceutical standards.

Strengths

• The patent covered a commercially important low-dose contraceptive composition.
• The FDA listing created a clear Hatch-Waxman litigation framework.
• Patent disputes could delay independent generic entry.
• The 24/4 regimen created a recognizable product identity.

Weaknesses

• The active ingredients were old and widely understood.
• The drug was an oral small molecule with relatively accessible manufacturing.
• Generic applicants could use the ANDA pathway.
• The product had no device or biologic manufacturing barrier.
• The commercial value depended heavily on timing rather than long-term exclusivity.

The estate was strong enough to support litigation and settlement negotiations. It was not strong enough to prevent eventual substitution by multiple generic products.

What patent litigation affects Loestrin 24 Fe today?

The historical patent litigation affected launch timing and settlement economics. It does not represent a major current barrier to generic access. With the core listed patent term ending around 2020 and generic products already established, current competition is primarily regulatory and commercial rather than patent-driven.

The main current risks for suppliers are:

• FDA approval and product-quality compliance
• Bioequivalence and manufacturing consistency
• State substitution rules
• Payer and pharmacy contracting
• Product recalls or supply interruptions
• Price competition among generic manufacturers

What is the geographic coverage of Loestrin 24 Fe protection?

The strongest historical protection was in the United States, where the Orange Book and Hatch-Waxman system governed patent listings, Paragraph IV certifications, and ANDA approval.

Outside the United States, protection depended on country-specific patents, regulatory exclusivity, and national reimbursement systems. A U.S. patent expiration did not automatically determine foreign market status. The commercial impact was also uneven because oral contraceptive markets differ in:

• Prescription reimbursement
• Over-the-counter access
• Generic substitution
• National tendering
• Local brand recognition
• Contraceptive prescribing patterns

The United States remains the most relevant jurisdiction for analyzing the product’s original patent litigation and revenue erosion.

What manufacturing and intellectual-property barriers remain?

Manufacturing barriers are limited. A competitor must produce tablets that meet FDA specifications for identity, strength, quality, purity, dissolution, stability, and bioequivalence. Those requirements create compliance costs but not a high barrier comparable to sterile injectables or biologics.

The remaining intellectual-property risks are more likely to involve:

• Labeling differences
• Packaging and trade dress
• Manufacturing-process claims
• Supplier agreements
• Regulatory exclusivity associated with a particular generic approval

These risks are secondary to the expired core composition patent.

Key Takeaways

• Loestrin 24 Fe is a small-molecule oral contraceptive containing norethindrone acetate and ethinyl estradiol.
• FDA approval occurred in 2006 under NDA 021871.
• U.S. Patent No. 6,667,050 was the principal historical Orange Book-listed patent.
• Actavis acquired Warner Chilcott, including Loestrin 24 Fe, in 2013.
• Generic competition emerged in the 2013-2014 period and materially reduced branded revenue.
• The core patent term reached its endpoint around 2020.
• Current competition is generic, not biosimilar.
• The product’s formulation and regimen supported differentiation but did not create a durable manufacturing barrier.
• Financial value migrated from the branded product to generic, authorized-generic, and residual supply economics.
• Current commercial risk is driven by price, payer access, supply reliability, and regulatory compliance rather than active patent exclusivity.

FAQs

Is Loestrin 24 Fe still a protected brand?

No. Loestrin 24 Fe no longer has meaningful market exclusivity. Generic equivalents compete through the FDA’s ANDA pathway.

What is the generic name for Loestrin 24 Fe?

The generic product is generally identified as norethindrone acetate and ethinyl estradiol tablets, with the applicable 24/4 regimen and, in some products, ferrous fumarate or other reminder tablets.

Did Loestrin 24 Fe have 180-day generic exclusivity?

Paragraph IV applicants could qualify for 180-day exclusivity if statutory conditions were met. The commercial impact depended on the specific applicant, settlement terms, and whether an authorized generic entered the market.

Is Loestrin 24 Fe a biologic drug?

No. It is a conventional oral small-molecule drug and is subject to generic, not biosimilar, competition.

Why did Loestrin 24 Fe sales decline so quickly?

Pharmacy substitution, lower generic prices, payer preference, and the availability of multiple equivalent products reduced both prescription volume and branded net price after generic entry.

References

1. U.S. Food and Drug Administration. (2006). Loestrin 24 Fe prescribing information and NDA 021871 records. FDA Drugs@FDA.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. Warner Chilcott plc. (2012). Annual report for the fiscal year ended December 31, 2012. U.S. Securities and Exchange Commission.

4. Actavis, Inc. (2014). Annual report for the fiscal year ended December 31, 2013. U.S. Securities and Exchange Commission.