DASETTA 1/35 Drug Patent Profile
Which patents cover Dasetta 1/35, and what generic alternatives are available?
Dasetta 1/35 is a drug marketed by Novast Labs Ltd and is included in one NDA.
The generic ingredient in DASETTA 1/35 is ethinyl estradiol; norethindrone. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
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Questions you can ask:
- What is the 5 year forecast for DASETTA 1/35?
- What are the global sales for DASETTA 1/35?
- What is Average Wholesale Price for DASETTA 1/35?
Summary for DASETTA 1/35
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | DASETTA 1/35 at DailyMed |
US Patents and Regulatory Information for DASETTA 1/35
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novast Labs Ltd | DASETTA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090948-001 | Dec 22, 2011 | 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 |
Dasetta 1/35 Market Dynamics, Patent Position, and Financial Trajectory
Dasetta 1/35 is a generic combined oral contraceptive containing norethindrone 1 mg and ethinyl estradiol 35 mcg. Its commercial position is driven by price, wholesaler access, pharmacy formulary placement, manufacturing reliability, and contraceptive-market demand rather than brand equity or patent exclusivity. Mayne Pharma is identified as the labeler in U.S. product information, but the company does not publicly report Dasetta 1/35 revenue as a standalone product. [1][2]
What is Dasetta 1/35 and who markets it?
Dasetta 1/35 is a 21-active-tablet oral contraceptive followed by seven inactive tablets. Each active tablet contains:
| Attribute | Product detail |
|---|---|
| Brand | Dasetta 1/35 |
| Active ingredients | Norethindrone 1 mg and ethinyl estradiol 35 mcg |
| Dosage form | Oral tablet |
| Therapeutic category | Combined hormonal contraceptive |
| U.S. regulatory status | Prescription drug |
| U.S. labeler | Mayne Pharma Inc. |
| Primary commercial market | U.S. retail and mail-order pharmacy |
| Product type | Generic oral contraceptive |
| Delivery system | Conventional immediate-release tablet |
The product is pharmacologically interchangeable with other norethindrone and ethinyl estradiol tablets meeting the applicable FDA requirements for the same strength and dosage form. The label includes standard contraindications and warnings for combined hormonal contraceptives, including thrombotic risk, cardiovascular events, smoking-related risk, and contraindications involving certain hepatic, vascular, and malignancy conditions. [1]
What is the FDA regulatory status of Dasetta 1/35?
Dasetta 1/35 is marketed through the FDA generic-drug pathway rather than as a newly approved branded contraceptive. Its commercial value therefore depends on an abbreviated new drug application, bioequivalence, manufacturing compliance, and continued product availability.
The product does not have the regulatory characteristics of a novel branded drug. It has no new chemical entity exclusivity, orphan-drug exclusivity, pediatric exclusivity, or other high-value regulatory protection associated with an innovative medicine. The product’s FDA economics are typical of mature generic oral contraceptives:
- Multiple manufacturers can compete with equivalent strengths.
- Substitution is generally governed by state pharmacy rules and payer formularies.
- Price competition can intensify when several suppliers remain active.
- Shortages or manufacturing interruptions can temporarily improve a supplier’s position.
The FDA’s Orange Book remains the relevant source for reference-listed-drug status, therapeutic equivalence codes, and any applicable listed patent information. Dasetta 1/35 should be analyzed primarily as a generic product linked to the norethindrone and ethinyl estradiol reference-product category, not as an independent innovative product with a substantial proprietary regulatory franchise. [3]
What patents protect Dasetta 1/35?
No commercially meaningful product-specific patent estate is apparent from the publicly available product labeling and the long-established composition of norethindrone and ethinyl estradiol. The active ingredients have been used in oral contraceptives for decades, and the basic 1 mg/35 mcg composition is not a recent invention.
| Patent category | Dasetta 1/35 position |
|---|---|
| Active-ingredient composition patent | No meaningful current protection expected |
| New chemical entity exclusivity | None |
| Core formulation patent | No publicly identified high-value protection |
| Method-of-use patent | No product-specific exclusivity identified |
| Device or delivery-system patent | Not applicable to the conventional tablet |
| Manufacturing-process patent | Possible at supplier level, but not publicly identified as a barrier |
| Patent litigation exposure | No major product-specific dispute identified in the cited public materials |
The absence of a visible patent barrier does not eliminate all intellectual-property risk. Suppliers may hold confidential process know-how, manufacturing specifications, trade secrets, or low-value formulation claims. Those rights generally do not create the same launch delay or pricing power as an enforceable composition or formulation patent.
When does Dasetta 1/35 lose exclusivity?
Dasetta 1/35 has no meaningful remaining exclusivity period to lose. It is a mature generic contraceptive, and its commercial protection is based on manufacturing and distribution execution.
The relevant timeline is:
| Period | Commercial significance |
|---|---|
| Historical development | Norethindrone and ethinyl estradiol become established contraceptive ingredients |
| Generic-market entry | Multiple equivalent products become available |
| Current market | Mature, price-sensitive, substitution-driven segment |
| Future exposure | Additional supplier entry, payer compression, and supply disruption |
Any short-term supply advantage would be operational rather than legal. A manufacturer could gain share if competitors experience an FDA warning letter, recall, shortage, contract-manufacturing failure, or wholesaler disruption. Such gains would not represent durable exclusivity.
How many patents cover Dasetta 1/35?
There is no reliable basis for assigning a meaningful number of active patents to Dasetta 1/35 as a marketed product. The product should not be valued using the patent-count framework applied to specialty pharmaceuticals or biologics.
A relevant distinction is necessary:
- Patents associated with a reference drug may not protect the generic manufacturer’s product.
- Patents listed for a different dose, regimen, indication, or delivery system may not cover Dasetta 1/35.
- Manufacturing patents may remain enforceable but are difficult to connect to a commercial product without litigation records or public prosecution data.
- Expired composition patents do not restrict current generic supply.
For transaction or litigation purposes, the practical patent conclusion is that Dasetta 1/35 has low exclusivity strength and limited patent-driven pricing power.
What generic entry risks exist for Dasetta 1/35?
Generic entry risk is already embedded in the product’s market structure. The principal threats are not future Paragraph IV launches against a protected product. They are continuing competition from equivalent norethindrone and ethinyl estradiol products.
Paragraph IV challenges
Paragraph IV litigation is unlikely to be commercially central for Dasetta 1/35 because the product is itself a mature generic and does not depend on an unexpired proprietary patent blocking competitors. The primary Paragraph IV risk would arise against a reference product or against a later manufacturer asserting a patent covering a particular formulation, manufacturing process, or regimen.
The likely commercial outcome of additional entry is:
- Lower average selling prices.
- Reduced pharmacy and wholesaler purchasing concentration.
- More frequent product switching.
- Lower contribution margins.
- Greater dependence on supply reliability.
Competitive substitution
The most direct competitors include other generic norethindrone and ethinyl estradiol tablets in the 1 mg/35 mcg strength, together with other combined oral contraceptives containing ethinyl estradiol paired with levonorgestrel, norgestimate, desogestrel, or drospirenone.
Dasetta 1/35 also competes indirectly with:
- Generic progestin-only pills.
- Long-acting reversible contraceptives.
- Transdermal patches.
- Vaginal rings.
- Emergency contraceptives.
- Branded or authorized-generic oral contraceptives.
The contraceptive method mix limits the ability of any single mature oral-tablet product to expand rapidly without a pricing or distribution advantage.
What formulations are protected by Dasetta 1/35?
The product is a conventional immediate-release tablet. No extended-release system, transdermal delivery technology, implant, injectable formulation, or proprietary dispensing device is associated with Dasetta 1/35.
Its commercial formulation value is therefore limited to:
- The specific active-ingredient combination.
- The 1 mg norethindrone and 35 mcg ethinyl estradiol strength.
- Tablet manufacturing quality.
- Packaging and labeling compliance.
- Reliable production and distribution.
These attributes support regulatory approval but do not ordinarily create strong commercial differentiation in a mature generic category.
What is the Orange Book status of Dasetta 1/35?
The Orange Book is relevant for confirming the reference product, therapeutic-equivalence information, and patent certifications associated with approved generic applications. Dasetta 1/35 should be evaluated through its FDA-approved generic application and its relationship to the applicable reference-listed drug.
The principal Orange Book implications are:
| Issue | Assessment |
|---|---|
| Reference product | Established combined oral contraceptive containing comparable active ingredients |
| Generic substitution | Central to commercial demand |
| Listed patent protection | No important product-blocking estate identified |
| Regulatory exclusivity | No material current exclusivity |
| Approval pathway | Abbreviated generic pathway |
| Commercial barrier | Manufacturing, supply, contracting, and price execution |
Orange Book status alone does not establish revenue potential. A therapeutically equivalent rating can improve pharmacy substitution, but the supplier still needs adequate wholesaler inventory and competitive net pricing.
How strong is the patent estate for Dasetta 1/35?
The patent estate is weak from a commercial-defense perspective. Dasetta 1/35 has the profile of a commodity generic:
| Patent-strength factor | Assessment |
|---|---|
| Composition protection | Weak or expired |
| Formulation differentiation | Limited |
| Method-of-use protection | Not material to the core product |
| Manufacturing protection | Potentially relevant but not publicly established |
| Litigation leverage | Low |
| Ability to delay competitors | Low |
| Long-term pricing power | Low |
This profile lowers legal barriers to entry but also reduces the value of patent litigation as a defensive strategy. Product economics depend more heavily on cost control and supply-chain performance.
How does Dasetta 1/35 compare with competing contraceptives?
| Product category | Patent position | Pricing power | Clinical differentiation | Competitive threat |
|---|---|---|---|---|
| Dasetta 1/35 and equivalent generics | Low | Low | Limited | High |
| Other generic combined oral contraceptives | Low | Low | Moderate by hormone combination | High |
| Branded oral contraceptives | Variable | Moderate | Branding, regimen, or formulation | Moderate |
| Long-acting reversible contraceptives | Product-specific patents may apply | Higher | High duration and adherence benefits | High |
| Generic progestin-only pills | Low to moderate | Low | Different contraindication profile | Moderate |
| Transdermal and vaginal products | Variable | Moderate | Alternative administration | Moderate |
Long-acting products can capture patients seeking reduced daily adherence. Generic oral contraceptives retain a large addressable market because of low acquisition cost, clinician familiarity, and pharmacy availability.
What is the financial trajectory for Dasetta 1/35?
No standalone Dasetta 1/35 revenue, gross profit, volume, or market-share series is publicly reported in the cited company and regulatory materials. The financial trajectory must therefore be assessed qualitatively rather than as a product-level forecast. [2]
The expected trajectory is mature-to-declining revenue per unit, with potential volatility in total sales caused by supply conditions.
Revenue drivers
The main positive drivers are:
- Continued demand for prescription contraception.
- Broad pharmacy access.
- Low patient acquisition cost.
- Product substitution during competitor shortages.
- Stable demand for conventional oral tablets.
- Potential wholesaler or payer contracts.
Revenue pressures
The primary pressures are:
- Generic price erosion.
- Multiple equivalent suppliers.
- Payer reimbursement compression.
- Retail pharmacy purchasing concentration.
- Low switching costs.
- Limited product differentiation.
- Manufacturing and compliance costs.
- Substitution by long-acting or nonoral contraceptive methods.
A reasonable commercial model places Dasetta 1/35 in the low-growth or declining mature-generic category. Revenue can rise temporarily if competing products are unavailable, but the product lacks the patent or brand protection needed to sustain premium pricing.
Which companies are challenging Dasetta 1/35?
The relevant challengers are manufacturers of therapeutically equivalent norethindrone and ethinyl estradiol tablets and suppliers of alternative generic contraceptives. The competitive field includes large generic companies, specialty generic manufacturers, contract manufacturers, and private-label suppliers.
The principal competitive variables are:
- FDA-compliant manufacturing capacity.
- Wholesale acquisition cost and net price.
- Fill rates and inventory continuity.
- Pharmacy-benefit-manager access.
- Regulatory inspection history.
- Ability to absorb low-margin production.
- Commercial relationships with distributors.
Because the market has low switching costs, a competitor with better availability can capture prescriptions even without a superior clinical product.
What litigation and settlement agreements affect Dasetta 1/35?
No major Dasetta 1/35-specific patent litigation or settlement agreement is identified in the cited public materials. The product does not present the typical litigation pattern associated with a high-value branded drug facing a first generic launch.
Any material future dispute would more likely involve:
- Manufacturing specifications.
- Product quality or recall issues.
- Contract disputes.
- Distributor obligations.
- Labeling or advertising compliance.
- Patent claims directed to a supplier’s process rather than the basic contraceptive composition.
The absence of identified litigation reduces legal overhang but also confirms that the product has limited proprietary protection.
What manufacturing and geographic barriers affect Dasetta 1/35?
The principal barriers are operational. The product requires compliant production of low-dose hormonal tablets, validated uniformity, reliable packaging, and adherence to FDA current good manufacturing practice requirements.
Geographic exposure is concentrated in the U.S. prescription market. International growth is not automatic because:
- Brand names differ by jurisdiction.
- National approvals and labeling requirements vary.
- Contraceptive reimbursement systems differ.
- Local suppliers may have established distribution.
- Patent and regulatory records must be assessed country by country.
Manufacturing concentration can create temporary pricing opportunities if a major supplier exits or experiences a shortage. Those opportunities usually attract replacement capacity and do not create durable market power.
Key Takeaways
- Dasetta 1/35 contains norethindrone 1 mg and ethinyl estradiol 35 mcg.
- It is a mature generic oral contraceptive marketed under the Mayne Pharma label.
- No meaningful product-specific patent estate or remaining exclusivity has been identified.
- Paragraph IV litigation is not the principal commercial risk.
- The central risks are price erosion, equivalent generic competition, payer pressure, and manufacturing disruption.
- Mayne Pharma does not publicly disclose standalone Dasetta 1/35 revenue.
- The product’s financial trajectory is best characterized as mature, low-margin, and potentially declining on a per-unit basis.
- Temporary sales gains are most likely to come from competitor shortages or distribution advantages.
- Long-term value depends on cost control, supply reliability, and contracting rather than intellectual property.
FAQs
Is Dasetta 1/35 still available in the United States?
Dasetta 1/35 is identified in U.S. drug-labeling records as a prescription norethindrone and ethinyl estradiol tablet marketed by Mayne Pharma. Actual pharmacy availability can vary by wholesaler inventory, manufacturer supply, and local substitution practices. [1]
Is Dasetta 1/35 a branded drug or a generic drug?
Dasetta 1/35 is a generic oral contraceptive product marketed under a product name. Its commercial position is based on generic approval and therapeutic substitution rather than innovative-drug exclusivity.
Can a generic manufacturer launch a competing Dasetta 1/35 product?
A competing manufacturer may seek FDA approval for an equivalent norethindrone and ethinyl estradiol tablet, subject to applicable abbreviated-application, bioequivalence, manufacturing, labeling, and patent-certification requirements.
Does Dasetta 1/35 have biosimilar competition?
No. Biosimilar rules apply to biological products. Dasetta 1/35 is a chemically synthesized small-molecule tablet and faces ordinary generic competition.
Is Dasetta 1/35 an attractive licensing asset?
Its licensing value is likely limited unless the transaction includes manufacturing capacity, distribution contracts, a broader contraceptive portfolio, or access to supply-constrained channels. The product alone has limited patent protection and low expected pricing power.
References
- DailyMed. (n.d.). Dasetta-1/35: Norethindrone and ethinyl estradiol tablet, film coated. U.S. National Library of Medicine.
- Mayne Pharma Limited. (2024). Annual report and company disclosures.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.
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