AUROVELA FE 1/20 Drug Patent Profile
Which patents cover Aurovela Fe 1/20, and when can generic versions of Aurovela Fe 1/20 launch?
Aurovela Fe 1/20 is a drug marketed by Aurobindo Pharma and is included in one NDA.
The generic ingredient in AUROVELA FE 1/20 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 AUROVELA FE 1/20
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| DailyMed Link: | AUROVELA FE 1/20 at DailyMed |
US Patents and Regulatory Information for AUROVELA FE 1/20
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | AUROVELA FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 207505-001 | Jun 16, 2017 | AB | RX | No | 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 |
Aurovela Fe 1/20 Market Dynamics, Patent Status, Competition, and Financial Trajectory
Aurovela Fe 1/20 is a generic combined oral contraceptive containing norethindrone acetate 1 mg and ethinyl estradiol 20 mcg, packaged with four ferrous fumarate tablets. Aurobindo Pharma markets the product in the United States. Its commercial profile is defined by low regulatory barriers, intense generic competition, pharmacy-channel substitution, and limited product-level financial disclosure.
The product has no meaningful brand-style patent moat. Its principal commercial risks are price erosion, formulary placement, manufacturing continuity, wholesaler inventory decisions, and substitution by other low-dose oral contraceptives.
What is Aurovela Fe 1/20 and how is it positioned?
Aurovela Fe 1/20 is a 28-day oral contraceptive regimen:
| Product element | Description |
|---|---|
| Active hormonal ingredients | Norethindrone acetate 1 mg and ethinyl estradiol 20 mcg |
| Non-hormonal tablets | Ferrous fumarate 75 mg per tablet |
| Dosing format | 24 active tablets followed by four ferrous fumarate tablets |
| Therapeutic category | Combined hormonal oral contraceptive |
| Regulatory pathway | Abbreviated New Drug Application, or ANDA |
| U.S. marketer | Aurobindo Pharma USA |
| Reference product category | Norethindrone acetate and ethinyl estradiol tablets, USP |
| Primary use | Prevention of pregnancy |
| Prescription status | Prescription-only oral contraceptive |
The ferrous fumarate tablets are included as inert reminder tablets from a contraceptive standpoint. The product labeling states that the iron tablets do not provide contraceptive activity. The regimen is designed to maintain daily tablet-taking during the tablet-free interval that would otherwise occur with a conventional 21-day hormonal pack.[1]
Aurovela Fe 1/20 is generally positioned as a lower-cost alternative to branded or authorized-generic products using the same hormonal combination. It competes primarily on acquisition cost, supply reliability, wholesaler availability, payer coverage, and pharmacy substitution rather than on clinical differentiation.
What is the FDA regulatory status of Aurovela Fe 1/20?
Aurovela Fe 1/20 is an FDA-approved generic oral contraceptive. Its ANDA approval demonstrates bioequivalence to the applicable reference product rather than independent clinical superiority.
The FDA approval framework for generic combined oral contraceptives typically requires:
- Pharmaceutical equivalence in active ingredients, strength, dosage form, and route of administration.
- Bioequivalence to the reference listed drug.
- Compliance with manufacturing, quality, labeling, and facility requirements.
- Demonstration that the generic can be substituted without requiring new efficacy trials comparable to those conducted for the original innovator product.[2]
Aurovela Fe 1/20 is not a biologic and does not face biosimilar competition. It is a conventional small-molecule product. The relevant competitive pathway is ANDA approval and generic substitution, not the Biologics Price Competition and Innovation Act pathway.
What is the Orange Book status of Aurovela Fe 1/20?
Aurovela Fe 1/20 is a generic product rather than an innovator product with a standalone Orange Book patent estate. Generic contraceptive products generally do not carry the same product-specific patent protection that supports branded small-molecule exclusivity.
The commercial consequence is direct:
| Exclusivity category | Aurovela Fe 1/20 position |
|---|---|
| New chemical entity exclusivity | None |
| Five-year new-drug exclusivity | None |
| Three-year clinical-investigation exclusivity | None |
| Pediatric exclusivity | Not associated with the generic product |
| Orphan-drug exclusivity | None |
| Biosimilar interchangeability exclusivity | Not applicable |
| Generic approval exclusivity | No meaningful current barrier expected for a mature product |
| Orange Book patent moat | Limited or absent at the generic product level |
The Orange Book may list patents for reference products or branded contraceptive formulations, but those listings do not create a durable patent barrier around Aurovela Fe 1/20 itself. FDA Orange Book records distinguish reference listed drugs, approved generics, patents, and exclusivity periods.[3]
When does Aurovela Fe 1/20 lose exclusivity?
Aurovela Fe 1/20 entered the market as a generic product and therefore did not have a conventional branded exclusivity runway. Its commercial exclusivity was effectively absent once competing ANDA products became available.
The relevant timeline is:
| Event | Commercial effect |
|---|---|
| Original innovator approval of the hormone combination | Established the reference product and clinical labeling |
| Generic ANDA approval | Allowed Aurobindo to market a therapeutically equivalent product |
| Additional generic approvals | Increased price competition and substitution |
| Mature generic phase | Shifted value from exclusivity to manufacturing scale and supply reliability |
| Ongoing market period | Revenue depends on volume, net price, channel access, and product availability |
Patent expiration dates for the original contraceptive formulation are less important than current ANDA competition. By the time a mature generic such as Aurovela Fe 1/20 is commercialized, the major economic barrier is usually no longer patent protection. The principal barrier is whether the manufacturer can produce the product consistently at a competitive cost.
How many patents cover Aurovela Fe 1/20?
No material product-specific patent estate is associated with Aurovela Fe 1/20 in the manner seen for a protected branded medicine.
Potentially relevant intellectual-property categories include:
- Formulation patents for extended-release or modified-release contraceptives.
- Delivery-system patents for vaginal rings, implants, patches, or other non-oral products.
- Manufacturing-process patents.
- Packaging or regimen patents.
- Patents associated with branded reference products.
Those categories generally do not prevent marketing of a conventional immediate-release norethindrone acetate and ethinyl estradiol tablet when the generic sponsor has obtained FDA approval.
What formulations are protected by Aurovela Fe 1/20?
The product’s commercial formulation is a 28-tablet pack with 24 hormonal tablets and four ferrous fumarate tablets. The formulation has limited differentiation because similar 24/4 oral contraceptive regimens are widely available.
Its main formulation characteristics are:
- Low-dose ethinyl estradiol content.
- Norethindrone acetate progestin component.
- Oral tablet delivery.
- Four non-hormonal iron tablets in each monthly package.
- Conventional immediate-release administration.
The iron tablets may improve adherence by preserving daily tablet-taking, but they do not create a strong patent or pricing advantage. Competitors can offer equivalent or closely substitutable regimens, including products with placebo tablets that do not contain iron.
Which companies compete with Aurovela Fe 1/20?
Aurovela Fe 1/20 competes with generic manufacturers of norethindrone acetate and ethinyl estradiol combinations, as well as branded and authorized-generic oral contraceptives.
Relevant competitor groups include:
| Competitor group | Examples of competitive pressure |
|---|---|
| Other generic tablet manufacturers | Lower contract and wholesale prices |
| Authorized generics | Brand-equivalent products distributed at generic prices |
| Branded oral contraceptives | Patient and prescriber loyalty, marketing, and specific regimen positioning |
| Alternative combined pills | Products using levonorgestrel, drospirenone, desogestrel, or other progestins |
| Progestin-only pills | Avoidance of estrogen-related contraindications |
| Long-acting contraceptives | IUDs, implants, and injections that reduce monthly pill demand |
| Transdermal and vaginal products | Alternative delivery systems and adherence profiles |
Competition is not limited to products with identical ingredients. Prescribers and payers often treat oral contraceptives as a broad therapeutic class, particularly when a patient has no strong clinical reason to remain on a specific progestin-estrogen combination.
What generic entry risks affect Aurovela Fe 1/20?
The risk of additional generic entry is high because the product is an established small-molecule oral tablet with no evident technical barrier to replication.
Paragraph IV challenges
Paragraph IV certifications are generally more relevant when an ANDA applicant seeks approval before expiration of listed reference-product patents. For a mature oral contraceptive combination, the practical relevance of new Paragraph IV litigation is limited unless a specific listed patent remains active.
The more likely competitive mechanism is ordinary ANDA approval after relevant patent and exclusivity barriers have expired or become commercially immaterial. FDA’s publication of approved drug products and patent information provides the formal regulatory framework for assessing this status.[3]
Generic launch scenarios
| Scenario | Likely market effect |
|---|---|
| One or two suppliers remain active | Moderate price pressure; supply reliability supports margins |
| Several suppliers compete | Faster wholesale price erosion and lower manufacturer net revenue |
| Major supplier exits | Temporary price recovery or allocation constraints |
| Aurobindo gains preferred formulary status | Higher unit volume with lower net pricing |
| Product moves to secondary status | Volume decline and loss of pharmacy pull-through |
| Manufacturing interruption | Short-term revenue loss and potential substitution to competitors |
For a mature generic contraceptive, a new entrant can gain share rapidly if it offers reliable inventory and favorable wholesaler economics. Conversely, a manufacturer can lose share without a regulatory event if its product is backordered or removed from a payer-preferred tier.
What patent litigation affects Aurovela Fe 1/20?
No major product-specific patent litigation involving Aurovela Fe 1/20 is identified in the public regulatory profile used for this analysis. This is consistent with the product’s generic status and the age of the underlying contraceptive technology.
Litigation risk is more likely to arise from:
- Manufacturing-process disputes.
- Facility or quality enforcement matters.
- Contract disputes with distributors.
- Product liability claims.
- Patent litigation involving a branded competitor or alternative contraceptive technology.
Those matters would not necessarily prevent Aurobindo from marketing Aurovela Fe 1/20 unless they produced an injunction, recall, import restriction, or supply interruption.
How strong is the patent estate for Aurovela Fe 1/20?
The patent estate is weak as a source of exclusivity and irrelevant to long-term pricing power. The product’s defensibility comes from execution rather than patents.
| Business asset | Strength |
|---|---|
| Composition-of-matter protection | Low or absent |
| Formulation protection | Low |
| Delivery technology | None beyond conventional oral tablets |
| Regulatory approval | Established |
| Manufacturing know-how | Potentially important but not publicly quantifiable |
| Supply-chain capability | Material commercial differentiator |
| Brand recognition | Limited compared with major branded contraceptives |
| Payer and wholesaler access | Potentially decisive |
| Switching costs | Low |
Aurobindo’s manufacturing network, regulatory experience, and ability to supply multiple generic products are more important than product-level intellectual property. The same attributes also apply to competitors, limiting differentiation.
What is the financial trajectory for Aurovela Fe 1/20?
Aurobindo does not separately report Aurovela Fe 1/20 revenue, gross profit, prescription volume, or market share in its public financial reporting. The product is included within broader U.S. generic pharmaceutical operations. A product-specific revenue forecast therefore cannot be supported by disclosed company financial statements.
The expected financial trajectory follows the standard mature-generic pattern:
- Initial launch period: Revenue depends on the number of competing approvals, launch timing, and initial wholesaler stocking.
- Share-building period: Volume can rise if Aurobindo secures payer or pharmacy placement.
- Mature competition: Net price typically declines as more suppliers enter.
- Stable low-margin phase: Revenue becomes primarily volume-driven.
- Exit or rationalization risk: The product may become uneconomic if prices fall below the manufacturer’s cost of goods, quality overhead, freight, and regulatory maintenance costs.
Aurobindo’s financial filings report performance at broader business and geographic levels rather than by individual generic SKU. The company’s generic portfolio includes many products, so Aurovela Fe 1/20 is unlikely to be a material standalone driver of consolidated revenue unless it holds unusually high market share or benefits from temporary supply shortages.[4]
Revenue exposure by variable
| Variable | Impact on Aurovela Fe 1/20 |
|---|---|
| Prescription volume | Positive, but often accompanied by lower prices as competition increases |
| Average selling price | Direct effect on revenue and gross margin |
| Number of approved suppliers | Usually negative for price and market share |
| Payer tier placement | Can materially affect volume |
| Wholesaler inventory | Affects near-term shipments and reported sales |
| Manufacturing yield | Affects gross margin |
| Active pharmaceutical ingredient cost | Direct cost pressure |
| Freight and import costs | Particularly relevant for imported products |
| Recalls or backorders | Can reduce sales and trigger substitution |
| Long-acting contraceptive uptake | Structural volume pressure |
How does Aurovela Fe 1/20 compare with competing contraceptive products?
Aurovela Fe 1/20 has a low-cost position but limited differentiation.
| Attribute | Aurovela Fe 1/20 | Branded combined pill | Progestin-only pill | Long-acting contraceptive |
|---|---|---|---|---|
| Delivery | Oral tablet | Usually oral tablet | Oral tablet | IUD, implant, or injection |
| Estrogen exposure | Yes | Depends on product | No | Product-dependent |
| Monthly adherence burden | High | High | High | Low after administration |
| Generic substitution | High | Varies | Increasing | Limited by device and procedure |
| Patent strength | Low | Product-specific | Varies | Often higher |
| Pricing power | Low | Higher if differentiated | Moderate to low | Higher |
| Primary commercial advantage | Cost and availability | Brand or clinical positioning | Estrogen avoidance | Duration and adherence |
The key competitive threat is not a single direct substitute. It is the broad movement of contraceptive demand among generic oral pills, progestin-only options, IUDs, implants, and other delivery systems.
Are there licensing deals for Aurovela Fe 1/20?
Aurovela Fe 1/20 is publicly associated with Aurobindo’s generic commercial operations. No material product-specific licensing economics, royalty stream, or co-development arrangement is disclosed in the cited public materials.
The absence of disclosed licensing economics is commercially relevant. It means the product’s financial outcome is more likely to be determined by Aurobindo’s manufacturing cost, distribution agreements, generic competition, and U.S. pricing than by milestone obligations or royalty payments.
What manufacturing and IP barriers affect the product?
Manufacturing is the principal operational barrier. The product requires control of:
- Hormone assay and content uniformity.
- Tablet compression and coating.
- Stability over the labeled shelf life.
- Packaging of active and ferrous fumarate tablets in the correct sequence.
- Batch release and quality documentation.
- FDA-compliant facility operations.
- Reliable supply of norethindrone acetate and ethinyl estradiol.
The manufacturing process itself may contain confidential know-how, but confidential know-how does not provide the same market protection as an enforceable composition patent. A competitor that obtains FDA approval can generally compete without copying protected trade secrets.
Key Takeaways
- Aurovela Fe 1/20 is Aurobindo’s generic 24/4 oral contraceptive containing norethindrone acetate 1 mg and ethinyl estradiol 20 mcg.
- The product has no meaningful generic-style exclusivity or product-level patent moat.
- Orange Book and patent considerations are secondary to ANDA competition, payer access, and supply reliability.
- Paragraph IV litigation is not the primary current risk for this mature generic.
- Biosimilar competition is not applicable because Aurovela Fe 1/20 is a conventional small-molecule tablet.
- Product-level revenue, margin, and market-share data are not separately disclosed by Aurobindo.
- The financial trajectory is likely volume-driven, with price erosion as additional generic suppliers compete.
- Manufacturing continuity, inventory availability, and wholesaler economics are the strongest commercial differentiators.
- Alternative oral contraceptives, progestin-only products, IUDs, implants, and other delivery systems create broader therapeutic competition.
- The principal downside scenario is loss of volume or margin following new generic entry, supply interruption, or payer displacement.
FAQs
Is Aurovela Fe 1/20 the same as Microgestin Fe 1/20?
They contain the same active hormonal ingredients and strengths, but they are marketed by different companies. Therapeutic equivalence depends on the FDA-approved generic product and its labeling, not on identical commercial branding.
Does Aurovela Fe 1/20 contain iron for anemia treatment?
No. The ferrous fumarate tablets are non-hormonal reminder tablets and are not intended to treat iron-deficiency anemia.[1]
Can pharmacies automatically substitute Aurovela Fe 1/20 for a branded contraceptive?
Substitution depends on FDA therapeutic-equivalence determinations, state pharmacy law, payer rules, and the prescriber’s instructions. The pharmacist and applicable state requirements control the substitution decision.
Is Aurovela Fe 1/20 exposed to biosimilar competition?
No. Biosimilar regulation applies to biologic products. Aurovela Fe 1/20 is a small-molecule oral tablet and competes through the generic-drug pathway.
What would most improve Aurovela Fe 1/20 profitability?
Higher prescription volume combined with stable pricing, preferred payer placement, reliable manufacturing, lower active-ingredient costs, and fewer competing suppliers would provide the strongest improvement. Product-specific patent protection is not a realistic source of future upside.
References
-
DailyMed. (n.d.). Aurovela Fe 1/20: Norethindrone acetate and ethinyl estradiol tablets, and ferrous fumarate tablets prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
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U.S. Food and Drug Administration. (2023). Generic drug facts. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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Aurobindo Pharma Limited. (2024). Annual report 2023-24. https://www.aurobindo.com/investors/annual-reports/
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