LOESTRIN FE 1.5/30 Drug Patent Profile
When do Loestrin Fe 1.5/30 patents expire, and what generic alternatives are available?
Loestrin Fe 1.5/30 is a drug marketed by Teva Branded Pharm and is included in one NDA.
The generic ingredient in LOESTRIN FE 1.5/30 is ethinyl estradiol; norethindrone acetate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
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Summary for LOESTRIN FE 1.5/30
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | LOESTRIN FE 1.5/30 at DailyMed |
Recent Clinical Trials for LOESTRIN FE 1.5/30
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ViiV Healthcare | PHASE1 |
| Bristol-Myers Squibb | Phase 1 |
| Eisai Inc. | Phase 1 |
US Patents and Regulatory Information for LOESTRIN FE 1.5/30
| 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 FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 017355-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Loestrin Fe 1.5/30 Market Dynamics, Generic Competition, Patents and Financial Trajectory
Loestrin Fe 1.5/30 is a legacy combined oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg, with ferrous fumarate tablets included in the 28-day pack. The product was commercialized by Warner Chilcott and later became part of Actavis and Allergan’s women’s-health portfolio. Its commercial value declined after generic norethindrone acetate/ethinyl estradiol/ferrous fumarate products entered the U.S. market.
The product no longer has the characteristics of a protected branded growth asset. Its market is genericized, price-sensitive and fragmented among manufacturers. Public company filings do not separately disclose current Loestrin Fe 1.5/30 revenue, so the product’s financial trajectory must be assessed through brand erosion, generic availability, prescription share and portfolio-level disclosures rather than a standalone revenue line.
What is Loestrin Fe 1.5/30 and how is it used?
Loestrin Fe 1.5/30 is a monophasic oral contraceptive. Each active tablet contains:
| Component | Amount |
|---|---|
| Norethindrone acetate | 1.5 mg |
| Ethinyl estradiol | 30 mcg |
| Ferrous fumarate tablets | Included as nonhormonal reminder tablets |
The product is indicated for prevention of pregnancy in women who elect to use oral contraceptives. Its contraceptive effect is based primarily on suppression of ovulation, with additional effects on cervical mucus and the endometrium. The FDA labeling includes the class risks associated with combined hormonal contraceptives, including venous thromboembolism, arterial thrombotic events and cardiovascular risk in certain populations (U.S. Food and Drug Administration [FDA], n.d.-a).
Loestrin Fe 1.5/30 should be distinguished from Loestrin 24 Fe. The products use related hormones but have different dosing schedules. Loestrin 24 Fe uses 24 active tablets followed by four ferrous fumarate tablets, while the traditional Loestrin Fe 1.5/30 regimen generally uses 21 active tablets and seven iron-containing reminder tablets. Patent, litigation and revenue analyses that combine the products can overstate the protection or commercial performance of Loestrin Fe 1.5/30.
What is the FDA regulatory status of Loestrin Fe 1.5/30?
Loestrin Fe 1.5/30 was approved as a conventional small-molecule oral contraceptive under an FDA new drug application. It is not a biologic and does not create biosimilar exposure.
The market now includes abbreviated new drug application products with the same active ingredients, strengths and dosage form. Generic applicants typically rely on ANDA approval and demonstrate pharmaceutical equivalence and bioequivalence rather than repeat the originator’s full clinical efficacy program.
FDA regulatory characteristics
| Regulatory issue | Assessment |
|---|---|
| Product type | Combined oral contraceptive |
| Active ingredients | Norethindrone acetate and ethinyl estradiol |
| Dosage form | Oral tablets |
| FDA pathway for generics | ANDA |
| Biosimilar exposure | None |
| Therapeutic substitution | Generally high, subject to state pharmacy rules and payer policy |
| Current commercial structure | Brand legacy product plus multiple generic equivalents |
FDA-approved labeling and DailyMed records remain the primary sources for dosage, contraindications, warnings and administration requirements (FDA, n.d.-a; National Library of Medicine, n.d.).
When did Loestrin Fe 1.5/30 lose market exclusivity?
Loestrin Fe 1.5/30 lost practical market exclusivity when ANDA-approved generic equivalents became available. The relevant commercial event was generic entry, not the expiry of a single high-value patent covering a complex delivery system.
For a mature oral contraceptive, market exclusivity can be eroded by several routes:
- Expiration or invalidation of listed patents.
- Absence of enforceable Orange Book patents.
- ANDA approvals with Paragraph IV certifications.
- Authorized generic distribution.
- Manufacturer discontinuation or supply withdrawal.
The commercial product is now exposed to generic substitution. The exact timing of first generic entry should be determined from FDA approval and marketing-status records for the specific strength and package configuration, because Loestrin, Loestrin Fe and Loestrin 24 Fe had separate regulatory histories.
What patents protect Loestrin Fe 1.5/30?
The current patent position is weak relative to newer branded contraceptives and specialty pharmaceutical products. Loestrin Fe 1.5/30 is a conventional tablet with well-established active ingredients and no proprietary device or biologic manufacturing platform.
Relevant patent categories historically associated with oral contraceptive products include:
| Patent category | Relevance to Loestrin Fe 1.5/30 |
|---|---|
| Composition patents | Limited because the hormones are established active ingredients |
| Formulation patents | Potentially relevant to tablet composition, stability or packaging |
| Regimen patents | More relevant to extended-cycle or shortened hormone-free regimens |
| Method-of-use patents | Possible for contraceptive use, but generally weak after long clinical use |
| Manufacturing patents | Usually difficult to enforce against routine generic tableting |
| Device patents | Not relevant to the standard tablet product |
The FDA Orange Book is the controlling source for current listed patents and exclusivity entries. A commercial diligence review should treat historical patents for related products separately from active patents listed against Loestrin Fe 1.5/30. The product does not have the patent profile of a long-acting contraceptive device, injectable formulation or drug-device combination (FDA, n.d.-b).
How many patents cover Loestrin Fe 1.5/30?
There is no commercially meaningful active patent estate comparable to those protecting recently launched pharmaceutical products. The key issue is not the number of historical patent documents but whether any enforceable, listed patent blocks an ANDA applicant from approval or launch.
For this product:
- Composition protection is limited by the age of the ingredients.
- Conventional tablet formulation claims have limited exclusionary value.
- Method-of-use claims generally face prior-art and obviousness challenges.
- Manufacturing claims may be designed around.
- Related Loestrin 24 Fe patents should not automatically be attributed to Loestrin Fe 1.5/30.
The practical conclusion is that patent strength is low and generic entry risk is high.
Which companies compete with Loestrin Fe 1.5/30?
The main competitors are generic manufacturers selling norethindrone acetate and ethinyl estradiol tablets with ferrous fumarate. Depending on the period and package configuration, the competitive field has included large generic suppliers such as:
- Teva Pharmaceuticals
- Mylan, later part of Viatris
- Watson Pharmaceuticals, later part of Actavis and Allergan
- Glenmark Pharmaceuticals
- Lupin
- Amneal Pharmaceuticals
- Mayne Pharma
- Other ANDA holders and contract manufacturers
The competitive product is commonly marketed under generic names rather than as a differentiated branded product. Junel Fe 1.5/30 is one of the best-known generic or branded-generic references associated with the same hormone strengths, although product ownership and marketing status can change over time.
How does Loestrin Fe 1.5/30 compare with competing oral contraceptives?
| Product class | Commercial position versus Loestrin Fe 1.5/30 |
|---|---|
| Generic norethindrone acetate/ethinyl estradiol | Direct substitute and principal price competitor |
| Loestrin 24 Fe | Related branded product with different regimen |
| Microgestin Fe 1.5/30 | Branded-generic competitor |
| Junel Fe 1.5/30 | Major generic or branded-generic competitor |
| Yaz and generic drospirenone/ethinyl estradiol | Different progestin and risk-benefit profile |
| Ortho-Cyclen and generic norgestimate/ethinyl estradiol | Different progestin |
| NuvaRing and generic etonogestrel/ethinyl estradiol ring | Different delivery system |
| Long-acting reversible contraception | Competes on adherence and duration rather than tablet price |
Loestrin Fe 1.5/30 retains a place in formularies where norethindrone acetate is preferred, but it has limited differentiation against therapeutically substitutable generics.
What is the Orange Book status of Loestrin Fe 1.5/30?
The Orange Book determines whether FDA-listed patents or regulatory exclusivities affect ANDA approval. For a legacy product such as Loestrin Fe 1.5/30, the relevant commercial question is whether any current listed patent remains capable of delaying approval or launch.
The expected Orange Book profile is:
| Orange Book issue | Business implication |
|---|---|
| Listed patents | Must be checked against the exact NDA and strength |
| Hatch-Waxman exclusivity | Historical rather than commercially active |
| Pediatric exclusivity | Not a current barrier to generic competition |
| ANDA approval | Available for therapeutically equivalent products |
| 180-day exclusivity | Potentially relevant only to a specific first-filer |
| Reference-listed-drug status | Important for generic substitution and labeling |
Orange Book records can change as products are discontinued, relisted or transferred between sponsors. A patent review should therefore use the current FDA database and the historical NDA record, rather than relying on commercial references to “Loestrin patents” in the aggregate (FDA, n.d.-b).
What Paragraph IV challenges and litigation affected Loestrin products?
Generic oral contraceptive litigation has generally focused on listed patents covering dosing regimens, formulations or related product variants. Paragraph IV litigation can delay ANDA approval for up to 30 months when the relevant statutory conditions are met, but that mechanism is product-specific.
Loestrin 24 Fe generated more visible patent and generic-entry disputes than the conventional Loestrin Fe 1.5/30 product. The two products should not be treated as a single patent case. Litigation involving Loestrin 24 Fe may concern regimen patents or formulation claims that do not materially protect the 1.5/30 21-active-tablet product.
The current litigation risk for Loestrin Fe 1.5/30 is low because generic products are already established. Any future dispute would more likely involve:
- Product labeling or regulatory status.
- Manufacturing supply.
- Trademark or trade dress.
- Distribution contracts.
- Patent claims directed to a specific formulation or packaging configuration.
Are there settlement agreements involving Loestrin Fe 1.5/30?
Publicly known settlements involving Loestrin-related products have primarily had commercial importance where a generic applicant challenged patents covering a related formulation or dosing regimen. A settlement may establish an agreed generic launch date before patent expiry, authorize an early launch, or provide for licensed supply.
Settlement analysis must identify:
- The exact NDA.
- The exact dosage regimen.
- The patents asserted.
- The generic applicant.
- The agreed launch date.
- Any supply or authorized-generic provisions.
A settlement involving Loestrin 24 Fe should not be used as evidence of continuing protection for Loestrin Fe 1.5/30.
What was the financial trajectory of Loestrin Fe 1.5/30?
The product’s financial trajectory follows the standard lifecycle of a mature branded oral contraceptive:
| Period | Financial condition |
|---|---|
| Pre-generic commercialization | Brand pricing, physician promotion and portfolio contribution |
| Generic-entry period | Rapid price pressure and prescription substitution |
| Post-generic period | Declining brand volume, lower net price and reduced promotional support |
| Mature generic market | Low unit economics, manufacturer competition and supply-driven revenue |
| Current status | Limited standalone value and minimal strategic differentiation |
Warner Chilcott generated meaningful women’s-health revenue before its acquisition by Actavis in 2013. The company’s public reports disclosed women’s-health products at portfolio or product-family levels, but Loestrin Fe 1.5/30 revenue was not consistently reported as a standalone line item. Allergan’s subsequent reporting also grouped products into broader therapeutic categories rather than providing a current, separately audited revenue figure for this product (Actavis, 2013; Allergan, 2014).
The likely revenue pattern was:
- High gross-to-net revenue while the branded product retained formulary access.
- Rapid erosion after generic substitution.
- Reduced brand investment once generic equivalents became available.
- Residual revenue from legacy prescriptions, non-substitutable prescriptions and channel-specific demand.
- No meaningful long-term growth case absent a reformulation or relaunch.
What manufacturing and intellectual-property barriers remain?
Manufacturing barriers are modest. The product uses established active pharmaceutical ingredients and conventional oral-tablet manufacturing. The principal operational risks are:
- API sourcing for norethindrone acetate and ethinyl estradiol.
- Low-dose content uniformity.
- Hormone potency and stability.
- Tablet coating and packaging controls.
- Ferrous fumarate tablet inclusion and pack assembly.
- Quality-system compliance.
- FDA inspection and supply continuity.
These requirements can create short-term supply constraints, but they do not create durable market exclusivity. A competitor with an approved ANDA and qualified manufacturing network can generally enter on price, availability and distributor relationships.
What generic launch scenarios exist for Loestrin Fe 1.5/30?
The product’s generic launch scenarios are already mature:
Continued generic substitution
This is the base case. Pharmacies and payers favor lower-cost equivalent products, reducing branded volume.
Supply-constrained price spikes
Temporary shortages or manufacturer exits can increase prices or shift share between generic suppliers. These events are usually short-lived and do not restore durable brand power.
Authorized-generic strategy
A brand owner or licensee could supply an authorized generic to retain manufacturing volume or capture part of the generic market. The strategy would have limited value without scale.
Brand discontinuation
If maintaining the branded NDA and commercial infrastructure costs more than the remaining revenue, the brand may be discontinued while generic products remain available.
Reformulation or regimen relaunch
A new regimen, delivery system or indication could create a separate commercial product, but that would require new clinical, regulatory and patent work. It would not revive the legacy Loestrin Fe 1.5/30 franchise automatically.
What is the geographic coverage of Loestrin Fe 1.5/30?
The strongest historical commercial footprint is in the United States, where the product was regulated under an NDA and competed through the U.S. pharmacy-benefit system. Generic availability outside the United States depends on national registrations, local brand names and procurement channels.
Potential geographic constraints include:
- Different regulatory approvals for hormone strengths.
- Country-specific contraceptive labeling.
- Local substitution rules.
- Separate trademark ownership.
- Distinct reimbursement systems.
- National tender pricing.
U.S. Orange Book status does not establish patent or regulatory status in Europe, Canada, Latin America or Asia. International rights must be evaluated jurisdiction by jurisdiction.
How strong is the Loestrin Fe 1.5/30 commercial and patent estate?
| Attribute | Assessment |
|---|---|
| Product differentiation | Low |
| Patent strength | Low |
| Generic entry risk | High |
| Manufacturing complexity | Low to moderate |
| Biosimilar risk | Not applicable |
| Brand pricing power | Low |
| Prescription durability | Moderate where patients remain stable on therapy |
| Revenue growth potential | Low |
| Litigation value | Low, except for specific historical claims |
| Licensing value | Limited |
The asset may retain operational value as a generic supply product, but it has little standalone value as a branded patent asset. Any acquisition or licensing valuation should focus on approved-market share, net price, manufacturing cost, supply reliability and channel contracts rather than patent duration.
Key Takeaways
- Loestrin Fe 1.5/30 is a legacy combined oral contraceptive containing norethindrone acetate and ethinyl estradiol.
- Generic equivalents have materially reduced branded pricing power and revenue.
- The product has no biosimilar issue because it is a conventional small-molecule tablet.
- Its patent estate is weak relative to newer pharmaceutical products and complex contraceptive technologies.
- Loestrin 24 Fe should be analyzed separately because its regimen and historical patent disputes differ.
- Public filings do not provide a reliable current standalone revenue figure for Loestrin Fe 1.5/30.
- The principal commercial risks are generic substitution, price compression and supply competition.
- The product’s remaining value is primarily operational and portfolio-based, not patent-based.
FAQs
Is Loestrin Fe 1.5/30 still sold as a branded product?
Generic and branded-generic versions are the main commercial alternatives. Brand availability can vary by distributor, pharmacy and manufacturer status.
Is Junel Fe 1.5/30 the same as Loestrin Fe 1.5/30?
Junel Fe 1.5/30 uses the same principal hormone strengths as Loestrin Fe 1.5/30 and is generally treated as a therapeutic equivalent when FDA-approved for the relevant product configuration.
Does Loestrin Fe 1.5/30 have remaining patent protection?
The product does not have a strong commercially meaningful patent barrier. Current Orange Book records should be checked against the exact NDA and dosage form.
Why did Loestrin Fe 1.5/30 revenue decline?
Generic entry increased pharmacy substitution and reduced net pricing. Mature oral contraceptives also face intense competition from other pills, vaginal rings, injectables and long-acting contraceptives.
Can a company relaunch Loestrin Fe 1.5/30 as a growth product?
A conventional relaunch would have limited potential. Growth would require meaningful differentiation through a new regimen, delivery system, indication, reimbursement strategy or supply advantage.
References
Actavis, Inc. (2013). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2012.
Allergan, Inc. (2014). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2013.
National Library of Medicine. (n.d.). DailyMed: Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.
U.S. Food and Drug Administration. (n.d.-a). Prescribing information for Loestrin Fe and equivalent norethindrone acetate/ethinyl estradiol products.
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations: Orange Book.
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