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MICROGESTIN 1.5/30 Drug Patent Profile
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When do Microgestin 1.5/30 patents expire, and what generic alternatives are available?
Microgestin 1.5/30 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.
The generic ingredient in MICROGESTIN 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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Questions you can ask:
- What is the 5 year forecast for MICROGESTIN 1.5/30?
- What are the global sales for MICROGESTIN 1.5/30?
- What is Average Wholesale Price for MICROGESTIN 1.5/30?
Summary for MICROGESTIN 1.5/30
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Patent Applications: | 206 |
| DailyMed Link: | MICROGESTIN 1.5/30 at DailyMed |
US Patents and Regulatory Information for MICROGESTIN 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | MICROGESTIN 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 075548-002 | Jul 30, 2003 | 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 |
Microgestin 1.5/30 Market Dynamics, Patent Position, and Financial Trajectory
Microgestin 1.5/30 is a prescription combined oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg. Its commercial position is mature and largely genericized. The product has limited patent value, faces substitution from several equivalent oral contraceptives, and does not generate separately reported revenue in public company filings. Financial performance is therefore driven by prescription volume, payer reimbursement, pharmacy substitution, manufacturing cost, and brand retention rather than exclusivity.
What is Microgestin 1.5/30 and who markets it?
Microgestin 1.5/30 is a monophasic combined oral contraceptive. Each active tablet contains norethindrone acetate and ethinyl estradiol, followed by inactive tablets in the marketed pack configuration. The drug prevents ovulation and produces contraceptive effects through changes in cervical mucus and the endometrium (U.S. Food and Drug Administration [FDA], 2019; DailyMed, 2024).
| Attribute | Detail |
|---|---|
| Product | Microgestin 1.5/30 |
| Active ingredients | Norethindrone acetate 1.5 mg; ethinyl estradiol 30 mcg |
| Dosage form | Oral tablet |
| Therapeutic category | Combined hormonal contraceptive |
| Regulatory pathway | Prescription drug |
| Primary commercial market | United States |
| Product type | Mature branded/generic oral contraceptive |
| Current economic model | Low-margin, high-substitution prescription product |
| Public product-level revenue | Not separately disclosed |
Mayne Pharma has been associated with the U.S. commercial distribution of Microgestin products and other generic oral contraceptives. Corporate filings generally report revenue by business segment or product portfolio rather than identifying Microgestin 1.5/30 sales separately. As a result, standalone revenue, gross margin, and prescription figures cannot be established from public issuer disclosures.
What is the FDA regulatory status of Microgestin 1.5/30?
Microgestin 1.5/30 is an FDA-approved prescription contraceptive. FDA labeling identifies the product as a combination of norethindrone acetate and ethinyl estradiol and includes the standard contraindications for estrogen-containing contraceptives, including thrombotic risk, certain cardiovascular conditions, and hormone-sensitive cancers (FDA, 2019).
The regulatory record is commercially more important for substitution than for clinical differentiation. The active ingredients and strength are well established, and equivalent products can compete through abbreviated new drug applications, or ANDAs, when they meet FDA requirements for pharmaceutical equivalence and bioequivalence.
Is Microgestin 1.5/30 a new chemical entity?
No. Norethindrone acetate and ethinyl estradiol are established active ingredients with decades of clinical and commercial use. Microgestin 1.5/30 does not have new chemical entity exclusivity. Its value is based on an approved formulation, manufacturing reliability, distribution, and prescription continuity.
Is Microgestin 1.5/30 available over the counter?
No. Microgestin 1.5/30 remains a prescription product. In July 2023, FDA approved Opill, a progestin-only oral contraceptive, as the first U.S. nonprescription daily oral contraceptive. That decision expands consumer access to contraception but does not convert combined products such as Microgestin 1.5/30 to over-the-counter status (FDA, 2023).
What patents protect Microgestin 1.5/30?
Microgestin 1.5/30 has no commercially meaningful patent moat. The active ingredients are old, the product is a conventional tablet, and the principal competitive pathway is generic substitution.
The relevant protection profile is:
| Protection category | Commercial assessment |
|---|---|
| New chemical entity exclusivity | None |
| Orphan-drug exclusivity | None |
| Pediatric exclusivity | No material product-specific protection identified |
| Composition-of-matter patent | Not commercially relevant |
| Formulation patent | No material blocking formulation patent identified |
| Method-of-use patent | No material blocking patent identified |
| Manufacturing patent | Possible process know-how, but not a market exclusivity barrier |
| Orange Book patent barrier | No meaningful barrier identified |
A definitive patent review must distinguish the branded product from the active ingredients. Patents covering older contraceptive compounds or broad hormone combinations do not ordinarily block a manufacturer from marketing an equivalent norethindrone acetate and ethinyl estradiol product after those rights expire.
When does Microgestin 1.5/30 lose exclusivity?
Microgestin 1.5/30 has already lost practical market exclusivity. The product belongs to a mature contraceptive class with multiple equivalent products. Its commercial life is not governed by a single future loss-of-exclusivity date.
| Exclusivity type | Status |
|---|---|
| FDA new drug exclusivity | Expired or not commercially controlling |
| Patent exclusivity | No blocking protection identified |
| Generic entry | Already established |
| Paragraph IV exposure | Historical or product-specific, not central to current economics |
| Current competitive status | Open, multi-source market |
How many patents cover Microgestin 1.5/30?
No meaningful Orange Book patent estate appears to protect the product as a market-blocking asset. The practical answer for commercial planning is zero blocking patents. Any patent analysis should be conducted against the exact FDA-listed product, strength, manufacturer, and applicable reference-listed drug because contraceptive products with similar names can have different regulatory records.
What formulations are protected by Microgestin 1.5/30?
The formulation is a conventional oral tablet containing 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol. There is no clear evidence that the product has a proprietary extended-release system, novel delivery device, implant, transdermal platform, or complex formulation that would impede generic entry.
The formulation is commercially vulnerable for four reasons:
- The active ingredients are well characterized.
- The dosage form is a standard tablet.
- Bioequivalence can be evaluated using established FDA methods.
- Several competing combined oral contraceptives offer similar clinical positioning.
Any manufacturing advantage is more likely to involve supply-chain execution, tablet production, packaging, quality control, or procurement than enforceable product exclusivity.
Which companies challenge Microgestin 1.5/30 in the market?
Competition comes from both direct equivalents and clinically substitutable contraceptives.
Direct or near-direct competitors
The relevant competing products include generic norethindrone acetate and ethinyl estradiol tablets at the same or similar strengths, including products marketed under manufacturers' labels and other brand names. Manufacturers active in the broader U.S. generic oral contraceptive market have included Lupin, Glenmark, Amneal, Teva, and other FDA-approved generic suppliers, although product availability changes with discontinuations, supply constraints, and wholesaler decisions.
Clinical substitutes
Microgestin 1.5/30 also competes with:
- Norethindrone and ethinyl estradiol products at different strengths
- Levonorgestrel and ethinyl estradiol tablets
- Drospirenone and ethinyl estradiol products
- Desogestrel and ethinyl estradiol products
- Progestin-only pills
- Long-acting reversible contraceptives
- Transdermal patches and vaginal rings
- The nonprescription Opill product
The competitive set is therefore broader than products with the same ingredients. Prescribers and patients often select contraceptives based on tolerability, bleeding profile, formulary coverage, adherence, access, and prior experience.
What is the Orange Book status of Microgestin 1.5/30?
The Orange Book is relevant to the reference product and approved generic equivalents, but its commercial effect is limited for this mature product. The key issue is whether an FDA-listed product has unexpired patents or regulatory exclusivity that blocks an ANDA applicant. No significant remaining exclusivity barrier is commercially evident for Microgestin 1.5/30.
For generic competition, the decisive regulatory factors are:
- Pharmaceutical equivalence
- Bioequivalence
- Manufacturing compliance
- Product listing and labeling
- Availability of an approved ANDA
- Commercial supply
The absence of a patent barrier does not guarantee continuous generic supply. Manufacturers can still exit because of low reimbursement, quality costs, raw-material constraints, or insufficient volume.
Are there Paragraph IV challenges involving Microgestin 1.5/30?
Paragraph IV litigation is not a significant current market driver for Microgestin 1.5/30. Paragraph IV certifications are most economically important when a branded product has live patents with meaningful remaining term. Microgestin 1.5/30 is already in a multi-source market, so the principal risks are ordinary generic competition and price erosion rather than a new patent challenge.
Historical ANDA filings may have included patent certifications, but a product-specific litigation conclusion requires matching each ANDA to the exact reference-listed drug and patent listing in the FDA record. No active, high-value patent dispute is central to the present commercial profile.
What litigation and settlement agreements affect Microgestin 1.5/30?
No major active litigation or high-value settlement agreement is publicly identified as controlling current access to Microgestin 1.5/30. The product's risk profile differs from newer branded drugs because:
- The product has no evident patent thicket.
- Generic entry has already occurred.
- The active ingredients have long clinical histories.
- Price competition is more important than litigation.
- Commercial disputes are more likely to concern supply, contracting, or quality than exclusionary patent rights.
Any historic litigation involving norethindrone, ethinyl estradiol, oral contraceptive labeling, or other Microgestin strengths should not automatically be attributed to Microgestin 1.5/30.
How strong is the Microgestin 1.5/30 patent estate?
The patent estate is weak from a defensive commercial perspective.
| Patent-strength factor | Assessment |
|---|---|
| Core molecule protection | Very weak or absent |
| Novel formulation protection | Weak |
| Delivery technology | Absent |
| Method-of-use protection | Weak |
| Patent term remaining | No meaningful blocking term identified |
| Generic substitution defense | Low |
| Manufacturing know-how | Potentially useful but difficult to monetize as exclusivity |
| Litigation leverage | Low |
The product may retain commercial value through brand recognition and patient familiarity, but those attributes do not prevent substitution. The brand's economic defensibility is therefore substantially lower than that of a patented specialty drug or a complex drug-delivery product.
What is the financial trajectory for Microgestin 1.5/30?
Microgestin 1.5/30 is best modeled as a mature, declining or stable low-growth generic product rather than a growth asset.
Revenue drivers
Revenue depends on:
- Total U.S. oral contraceptive demand
- Prescription retention
- Brand-versus-generic dispensing rates
- Net price after rebates and wholesaler discounts
- Medicaid and commercial payer reimbursement
- Pharmacy purchasing decisions
- Product availability
- Manufacturing cost
- Competition from other hormonal contraceptives
Margin pressure
The product faces standard generic-market pressure:
| Financial factor | Likely effect |
|---|---|
| Multiple equivalent suppliers | Lower net price |
| Pharmacy substitution | Lower brand retention |
| Payer formulary controls | Lower reimbursement |
| High-volume manufacturing | Supports cost efficiency |
| Commodity active ingredients | Limits differentiation |
| Supply interruptions | Can temporarily improve pricing but reduce sales |
| Product discontinuation by competitors | Can improve share temporarily |
| OTC contraceptive expansion | Long-term access pressure across prescription products |
Microgestin 1.5/30 may generate recurring revenue where prescribers and patients remain familiar with the brand. However, the product is unlikely to have the pricing power or margin profile of a protected branded therapy. Public filings from manufacturers generally do not isolate the product, so an exact revenue curve cannot be calculated from reported financial statements.
How does Microgestin 1.5/30 compare with newer contraceptive products?
| Factor | Microgestin 1.5/30 | Newer branded contraceptive |
|---|---|---|
| Active ingredient novelty | Low | May be moderate or high |
| Patent protection | Minimal | Often material |
| Generic substitution | High | Lower before loss of exclusivity |
| Price power | Low | Higher |
| Clinical differentiation | Limited | May involve tolerability or delivery benefits |
| Regulatory risk | Established | More substantial |
| Revenue volatility | Driven by volume and price | Driven by access, promotion, and patent term |
| Investment profile | Harvest or portfolio product | Potential growth or exclusivity asset |
Microgestin 1.5/30 has a lower regulatory and clinical development risk profile but also limited upside. Its value lies in predictable demand and portfolio economics, not in patent-driven expansion.
What generic launch scenarios exist for Microgestin 1.5/30?
The relevant scenarios are commercial rather than litigation-driven.
Base case
Multiple suppliers remain active. Net prices stay under pressure, prescription volume remains broadly stable, and the product produces modest recurring revenue.
Downside case
A manufacturer exits because of low reimbursement or manufacturing costs. The remaining suppliers capture some volume, but the portfolio loses revenue if pharmacy substitution moves patients to other equivalent products.
Temporary upside case
A competitor experiences a shortage or discontinues the product. Microgestin 1.5/30 gains short-term volume or improved pricing until supply normalizes.
Strategic downside from OTC access
Greater use of nonprescription contraception, including Opill, expands consumer choice and may divert some demand from prescription contraceptives. The effect on a specific combined pill is likely gradual because Opill is progestin-only and has a different clinical profile.
What geographic markets are relevant?
The principal commercial market is the United States. The product's regulatory, patent, and reimbursement profile is jurisdiction-specific.
| Region | Commercial assessment |
|---|---|
| United States | Mature prescription market; generic substitution dominates |
| European Union | Separate national and EU regulatory records; product availability varies |
| Canada | Different drug authorization and reimbursement systems |
| Latin America | Brand and generic contraceptive markets vary by country |
| Emerging markets | Potential volume opportunity but lower prices and local registration requirements |
U.S. FDA approval does not establish market access in other jurisdictions. International expansion would require country-specific registrations, local pharmacovigilance, pricing approvals, and distribution arrangements.
What manufacturing and intellectual-property barriers exist?
Manufacturing barriers are moderate operationally but low legally. A supplier must maintain compliant facilities, validated processes, reliable hormone sourcing, stable packaging, and consistent quality. These requirements can constrain supply, but they do not create durable exclusivity.
The most important operational risks are:
- Active pharmaceutical ingredient availability
- Content uniformity and dissolution performance
- Stability and packaging controls
- FDA inspection outcomes
- Contract-manufacturing dependence
- Batch failures and recalls
- Wholesaler inventory decisions
For a mature oral contraceptive, manufacturing execution is more likely to affect market share than patent ownership.
Key Takeaways
- Microgestin 1.5/30 contains norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg.
- It is an established prescription combined oral contraceptive with no meaningful new-drug or patent exclusivity.
- Generic competition is already present, making the product a mature multi-source asset.
- The Orange Book and Paragraph IV landscape do not create a major current barrier to substitution.
- No major active patent litigation or settlement is central to the product's current commercial position.
- Product-level revenue is not separately disclosed, so financial analysis must rely on portfolio-level reporting and market structure.
- Revenue is driven by volume, supply continuity, payer reimbursement, and brand retention.
- Margin and price pressure are likely to persist as equivalent products and alternative contraceptive methods compete.
- The principal investment profile is stable or declining recurring revenue, not patent-backed growth.
FAQs
Is Microgestin 1.5/30 still commercially relevant?
Yes. It remains relevant as a familiar combined oral contraceptive, but its commercial importance is limited by generic substitution and low differentiation.
Does Microgestin 1.5/30 have a generic equivalent?
Yes. Equivalent norethindrone acetate and ethinyl estradiol products are available or have been approved in the U.S. generic market, subject to current product availability.
Can a generic manufacturer launch Microgestin 1.5/30 without a license?
A manufacturer with an approved ANDA can generally market an equivalent product after satisfying FDA requirements and addressing any applicable patents or exclusivities. No material blocking patent barrier is evident for the mature product.
Could Opill materially reduce Microgestin 1.5/30 sales?
Opill could increase competition for oral contraception, but it is progestin-only while Microgestin 1.5/30 is a combined estrogen-progestin product. Substitution will depend on clinical suitability, patient preference, prescriber behavior, and payer access.
Is Microgestin 1.5/30 an attractive licensing asset?
It may have value in a low-cost generic portfolio with established distribution, but it is unlikely to command a premium based on intellectual property. Licensing economics would depend on supply reliability, contracted volume, net pricing, and manufacturing cost.
References
DailyMed. (2024). Microgestin 1.5/30: Norethindrone acetate and ethinyl estradiol tablet labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
Mayne Pharma Limited. (2024). Annual report 2024. https://www.maynepharma.com/
U.S. Food and Drug Administration. (2019). Microgestin 1.5/30 prescribing information. FDA. https://www.accessdata.fda.gov/
U.S. Food and Drug Administration. (2023, July 13). FDA approves first nonprescription daily oral contraceptive. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
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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