ZOVIA 1/35E-28 Drug Patent Profile
Which patents cover Zovia 1/35e-28, and what generic alternatives are available?
Zovia 1/35e-28 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.
The generic ingredient in ZOVIA 1/35E-28 is ethinyl estradiol; ethynodiol diacetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
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Summary for ZOVIA 1/35E-28
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 56 |
| DailyMed Link: | ZOVIA 1/35E-28 at DailyMed |
US Patents and Regulatory Information for ZOVIA 1/35E-28
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | ZOVIA 1/35E-28 | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 072721-001 | Dec 30, 1991 | DISCN | 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 |
Zovia 1/35E-28 Market Dynamics, Patent Status, Generic Competition, and Financial Outlook
Zovia 1/35E-28 is a legacy combined oral contraceptive containing ethynodiol diacetate 1 mg and ethinyl estradiol 35 mcg in a 28-tablet regimen. Its commercial profile is mature and genericized. The product has no identifiable current patent-based exclusivity moat, no biosimilar exposure, and limited publicly reported product-level revenue. Financial performance depends on low-cost generic supply, pharmacy formulary placement, manufacturing continuity, and competition from newer oral contraceptives and long-acting contraceptive methods.
What is Zovia 1/35E-28 and who marketed it?
Zovia 1/35E-28 is a prescription combined hormonal contraceptive. The active ingredients are:
| Attribute | Product information |
|---|---|
| Brand | Zovia 1/35E-28 |
| Active ingredients | Ethynodiol diacetate 1 mg; ethinyl estradiol 35 mcg |
| Dosage form | Oral tablets |
| Pack size | 28 tablets |
| Therapeutic class | Combined oral contraceptive |
| Estrogen component | Ethinyl estradiol |
| Progestin component | Ethynodiol diacetate |
| FDA pathway | Small-molecule prescription drug |
| Current competitive class | Generic combined oral contraceptives |
| Biosimilar relevance | None |
Zovia is associated with historical U.S. marketing of ethynodiol diacetate and ethinyl estradiol tablets. The same active-ingredient combination has been marketed under the Kelnor name and through generic equivalents. FDA labeling identifies the pharmacologic class as oral contraceptives containing an estrogen and a progestin. [1]
The product is not a biologic, injectable contraceptive, implant, or controlled substance. Its commercial substitutes include other combined oral contraceptives containing ethinyl estradiol with norethindrone, levonorgestrel, norgestimate, desogestrel, or drospirenone.
When did Zovia 1/35E-28 lose exclusivity?
Zovia 1/35E-28 is a legacy product whose original regulatory and patent exclusivity periods expired many years ago. There is no current exclusivity period comparable to new-drug exclusivity, pediatric exclusivity, orphan exclusivity, or biologic exclusivity.
The relevant exclusivity position is:
| Exclusivity category | Current position |
|---|---|
| New chemical entity exclusivity | Expired |
| Five-year NCE exclusivity | Not currently applicable |
| Three-year clinical-investigation exclusivity | Expired |
| Pediatric exclusivity | None identified |
| Orphan exclusivity | Not applicable |
| Biologic exclusivity | Not applicable |
| Marketed-product exclusivity | None identified |
Ethynodiol diacetate and ethinyl estradiol have been used in oral contraceptive products for decades. The commercial opportunity therefore depends on abbreviated new drug applications, manufacturing approvals, and distribution rather than on a protected innovation period.
What patents protect Zovia 1/35E-28?
No active composition-of-matter patent or current formulation patent is expected to protect Zovia 1/35E-28 in the United States. Its active ingredients and conventional tablet formulation are long-established.
The principal patent conclusions are:
- The active ingredients are not protected by an unexpired composition patent.
- The 28-tablet oral regimen is conventional and does not create a meaningful standalone patent barrier.
- No current delivery-system patent is associated with the product.
- Method-of-use patents are unlikely to block contraceptive use of the active ingredients.
- Generic manufacturers can compete through approved abbreviated applications without licensing an innovator patent estate.
FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is the principal source for listed patents and regulatory exclusivity associated with approved products. A product’s absence of current patent listings does not prevent manufacture of generic versions; it generally indicates that patent-based delay is not the primary commercial constraint. [2]
What is the Orange Book status of Zovia 1/35E-28?
The commercial status of the original Zovia product and related versions must be separated from the status of generic products containing the same ingredients.
A product can be identified in FDA databases as discontinued while therapeutically equivalent products remain approved or marketed. FDA classifies products based on regulatory status and marketing information, not on whether a molecule remains commercially viable across the broader market. [3]
The practical Orange Book implications are:
| Issue | Assessment |
|---|---|
| Reference-product exclusivity | Expired |
| Patent-based generic delay | No current material barrier identified |
| Generic substitution | Available where an approved therapeutically equivalent product is stocked and state law permits substitution |
| Brand continuity | Dependent on commercial marketing, not patent protection |
| Regulatory risk | Product-specific supply or discontinuation risk can exceed patent risk |
The Orange Book should be reviewed at the product and application level because the historical Zovia label, later Kelnor products, and generic applications may not have identical marketing statuses.
How many patents cover Zovia 1/35E-28?
No material active U.S. patent estate is identifiable for the product’s established active ingredients, conventional tablet formulation, or contraceptive indication.
| Patent category | Estimated active U.S. barriers |
|---|---|
| Composition-of-matter patents | 0 material active barriers |
| Tablet formulation patents | 0 material active barriers |
| Delivery-system patents | 0 |
| Method-of-use patents | 0 material barriers |
| Manufacturing-process patents | Potentially confidential, but not expected to constrain routine tablet competition |
| Orange Book-listed blocking patents | No material current estate identified |
Manufacturing know-how can still matter. Suppliers may protect process controls, impurity specifications, analytical methods, or scale-up procedures as trade secrets. Those protections usually do not prevent a competing manufacturer from developing an independent process for an old oral contraceptive.
Are there Paragraph IV challenges to Zovia 1/35E-28?
A current Paragraph IV litigation risk is not commercially significant for Zovia 1/35E-28. Paragraph IV certifications challenge patents listed for an innovator product. They matter when unexpired Orange Book patents could delay generic approval or launch.
For this legacy contraceptive:
- The principal patent terms expired long ago.
- Generic entry does not depend on defeating a current patent estate.
- No active, high-value Paragraph IV dispute is associated with the product’s established formulation.
- Any historical patent certification activity would have had commercial relevance only before the product became fully genericized.
Paragraph IV filings may still appear in FDA litigation records for other contraceptive products, but those cases should not be attributed to Zovia without a product-specific docket or patent reference. [4]
What formulations are protected by Zovia patents?
No commercially relevant protected formulation has been identified for Zovia 1/35E-28.
The formulation is a conventional oral tablet containing:
- Ethynodiol diacetate
- Ethinyl estradiol
- Inactive tablet excipients
- A 28-day dosing presentation
The product does not rely on an extended-release matrix, transdermal delivery system, vaginal ring, implant, depot injection, or proprietary tablet technology. That limits opportunities for lifecycle management and reduces technical barriers to generic manufacturing.
The formulation’s principal technical risks are routine pharmaceutical controls:
- Low-dose content uniformity
- Stability of ethinyl estradiol
- Impurity control
- Dissolution consistency
- Packaging and moisture protection
- Batch-to-batch assay reproducibility
These are approval and quality-control requirements, not meaningful exclusivity mechanisms.
What generic entry risks exist for Zovia 1/35E-28?
Generic entry risk is high because the product has no meaningful patent protection and competes in a crowded contraceptive market.
The main generic competitors are products containing the same active ingredients, including ethynodiol diacetate and ethinyl estradiol tablets marketed under generic names or alternative brand names such as Kelnor. Generic substitution is supported by FDA approval standards requiring pharmaceutical equivalence and bioequivalence for approved abbreviated applications. [5]
Competitive pressure comes from four directions:
| Competitive factor | Impact on Zovia |
|---|---|
| Same-ingredient generics | High |
| Other combined oral contraceptives | High |
| Progestin-only pills | Moderate to high |
| Long-acting reversible contraception | High at the category level |
The product’s 35 mcg ethinyl estradiol strength also faces prescribing pressure from lower-estrogen formulations. Clinicians may select lower-dose products when clinically appropriate because estrogen exposure affects safety and tolerability considerations. Contraceptive selection is also influenced by acne, bleeding profile, venous thromboembolism risk, drug interactions, adherence, and patient preference. [1]
How does Zovia compare with competing contraceptives?
Zovia competes primarily on availability and price rather than differentiated clinical value.
| Product category | Typical differentiation versus Zovia |
|---|---|
| Norethindrone/ethinyl estradiol | Large generic supply base and broad formulary access |
| Levonorgestrel/ethinyl estradiol | Established low-cost generic competition |
| Norgestimate/ethinyl estradiol | Different tolerability and bleeding profiles |
| Drospirenone/ethinyl estradiol | Branded and generic options with differentiated progestin properties |
| Progestin-only pills | Estrogen-free option for patients with estrogen restrictions |
| Intrauterine devices | Long-acting contraception with higher upfront product cost |
| Etonogestrel implant | Long-acting delivery and adherence advantage |
| Depot medroxyprogesterone acetate | Injectable administration and longer dosing interval |
Zovia’s main disadvantage is the absence of a distinct delivery or dosing technology. Its main advantage is the established regulatory pathway and the possibility of low acquisition cost.
What is the financial trajectory for Zovia 1/35E-28?
No reliable public, standalone revenue series for Zovia 1/35E-28 has been disclosed by the historical or current manufacturers. Public company filings generally report product portfolios, business segments, or total pharmaceutical revenue rather than unit sales and net revenue for an old generic oral contraceptive.
The financial trajectory is therefore best characterized by market stage:
| Period | Financial profile |
|---|---|
| Early branded period | Higher price and stronger gross margin supported by brand recognition and limited competition |
| Generic-entry period | Price erosion and loss of pharmacy leverage |
| Mature generic period | Low unit economics, volume-dependent revenue, and tender or wholesaler pressure |
| Current/late-stage period | Revenue volatility driven by supply continuity, discontinuation decisions, and substitution |
A mature generic oral contraceptive can remain commercially viable with modest revenue if manufacturing costs are low and the product has stable pharmacy demand. The product can also become economically unattractive if several suppliers compete aggressively, reimbursement declines, or minimum batch sizes exceed demand.
The most likely financial pattern is:
- Declining price per prescription after generic entry.
- Narrower gross margins.
- Greater dependence on manufacturing scale.
- Periodic volume gains from competitor shortages.
- Revenue loss when wholesalers delist or pharmacies substitute other products.
- Potential discontinuation despite continuing clinical demand.
Public industry data from IQVIA, Symphony Health, or similar commercial sources would be required to quantify prescriptions, market share, gross sales, and net sales. Those product-level figures are not contained in FDA approval records or standard manufacturer filings.
Which companies are challenging Zovia in the market?
The relevant competitors are generic manufacturers and suppliers of alternative combined oral contraceptives rather than patent challengers.
Competitive pressure may come from:
- Manufacturers of ethynodiol diacetate/ethinyl estradiol tablets
- Suppliers of Kelnor 1/35 or equivalent products
- Large generic companies with broad oral contraceptive portfolios
- Contract manufacturers supplying private-label or pharmacy products
- Manufacturers of alternative estrogen-progestin combinations
The market is fragmented at the product level but concentrated in distribution. A manufacturer with limited brand recognition can still gain share through reliable supply, competitive wholesaler pricing, and preferred formulary status.
What manufacturing and intellectual-property barriers exist?
Manufacturing barriers are low to moderate. The active ingredients are established, and the dosage form is technically routine. The main barriers are operational:
- Qualified API suppliers
- Validated low-dose manufacturing processes
- Stability data
- Regulatory compliance
- Pharmacovigilance
- Scale economics
- Reliable packaging and distribution
Confidential manufacturing know-how may create a temporary cost advantage, but it does not provide the legal exclusivity associated with an issued patent. A competing manufacturer can use a different formulation process if it satisfies FDA quality and bioequivalence requirements.
Geographic protection is also limited. U.S. patent protection does not prevent lawful competition in Europe, Canada, or other markets after local rights expire. Commercial availability varies by jurisdiction because each market has separate product approvals, reimbursement rules, tender systems, and contraceptive prescribing practices.
Is there biosimilar risk for Zovia 1/35E-28?
Biosimilar risk is not applicable. Zovia 1/35E-28 is a synthetic small-molecule tablet, not a biologic. The relevant competitors are abbreviated new drug applications and generic products, not biosimilars under the Public Health Service Act.
The commercial threat from substitutes is still substantial because patients can switch to other oral contraceptives, progestin-only products, implants, intrauterine devices, or injectables.
What patent litigation and settlement agreements affect Zovia?
No material current patent litigation or settlement agreement is identified as a major commercial factor for Zovia 1/35E-28. The product’s market is governed by generic competition, regulatory status, supply, and reimbursement rather than active patent disputes.
Historical settlements involving other contraceptive products should not be used to infer a Zovia settlement. A valid attribution would require a named defendant, patent number, court docket, and product-specific settlement terms.
What are the likely generic launch scenarios?
Three scenarios describe the product’s remaining commercial trajectory.
Continued low-volume generic supply
One or more suppliers continue marketing the product at low prices. Revenue remains modest, but the product persists because manufacturing is inexpensive and demand is stable.
Temporary shortage-driven expansion
A competitor experiences a manufacturing or regulatory disruption. Remaining suppliers increase shipments and may gain temporary market share. The revenue effect is usually short-lived because alternative contraceptives are available.
Commercial discontinuation
The product is withdrawn because pricing no longer covers manufacturing, compliance, distribution, and pharmacovigilance costs. Prescriptions migrate to other ethynodiol diacetate products or alternative contraceptive formulations.
Key Takeaways
- Zovia 1/35E-28 contains ethynodiol diacetate 1 mg and ethinyl estradiol 35 mcg.
- Its original exclusivity and patent protection expired long ago.
- No material active U.S. patent estate currently protects the product.
- Paragraph IV litigation is not a significant current risk.
- The product is exposed to generic substitution and competing contraceptive classes.
- No biosimilar pathway applies.
- Standalone revenue, prescription volume, and market share are not publicly disclosed in standard FDA or company filings.
- The financial profile is that of a mature generic: low pricing, narrow margins, and revenue tied to supply reliability.
- Manufacturing capability, regulatory compliance, and distribution access matter more than intellectual property.
- The most probable long-term outcomes are continued low-volume supply or commercial discontinuation.
FAQs About Zovia 1/35E-28
Is Zovia 1/35E-28 still available?
Availability depends on the manufacturer, wholesaler inventory, and pharmacy sourcing. Products with the same active ingredients may remain available under generic or alternative brand names even if the original Zovia-branded product is no longer actively marketed.
What is the generic name for Zovia 1/35E-28?
The generic name is ethynodiol diacetate and ethinyl estradiol tablets, with strengths of 1 mg and 35 mcg, respectively.
Is Kelnor 1/35 the same as Zovia 1/35E-28?
Kelnor 1/35 uses the same active ingredients and strength. Therapeutic equivalence and substitutability depend on the specific FDA-approved product and applicable pharmacy law.
Can a manufacturer obtain a new patent on an old Zovia formulation?
A new patent would require a patentable modification, such as a novel formulation, delivery system, or manufacturing process that satisfies novelty and nonobviousness standards. The conventional Zovia tablet itself is unlikely to support a new enforceable patent.
What is the investment risk in a Zovia 1/35E-28 supplier?
The principal risks are low price, limited product differentiation, supply interruption, regulatory costs, and substitution by other contraceptives. The principal opportunity is stable demand combined with efficient manufacturing and reliable distribution.
References
- U.S. Food and Drug Administration. (2024). Oral contraceptives: Drug labeling and prescribing information. https://www.fda.gov
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov
- U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (2024). Paragraph IV patent certifications and patent litigation resources. https://www.fda.gov
- U.S. Food and Drug Administration. (2014). Guidance for industry: ANDAs for certain highly soluble, highly permeable, highly dosed drugs. https://www.fda.gov
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