AYGESTIN Drug Patent Profile
Which patents cover Aygestin, and what generic alternatives are available?
Aygestin is a drug marketed by Duramed Res and is included in one NDA.
The generic ingredient in AYGESTIN is norethindrone acetate. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the norethindrone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aygestin
A generic version of AYGESTIN was approved as norethindrone acetate by BARR on May 25th, 2001.
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Questions you can ask:
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Summary for AYGESTIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 5 |
| DailyMed Link: | AYGESTIN at DailyMed |
Recent Clinical Trials for AYGESTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Norton Healthcare | N/A |
| Scott and White Hospital & Clinic | Phase 4 |
| Boston Children’s Hospital | Phase 2 |
US Patents and Regulatory Information for AYGESTIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Duramed Res | AYGESTIN | norethindrone acetate | TABLET;ORAL | 018405-001 | Apr 21, 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 |
AYGESTIN Market Dynamics, Patent Status, Competitive Landscape, and Financial Trajectory
Aygestin is the branded 5 mg oral formulation of norethindrone acetate, a synthetic progestin used primarily for secondary amenorrhea, endometriosis, and abnormal uterine bleeding caused by hormonal imbalance. Its U.S. product is a mature, off-patent medicine with multiple generic alternatives. The commercial opportunity is concentrated in prescription demand for norethindrone acetate rather than in the Aygestin brand itself.
Public filings do not disclose standalone Aygestin revenue. The financial trajectory is therefore best assessed through product maturity, generic substitution, prescription demand, pricing, channel exposure, and the absence of meaningful regulatory exclusivity.
What is Aygestin and what is it used for?
Aygestin contains norethindrone acetate, a progestin administered orally in 5 mg tablets. The FDA-approved label identifies three principal uses:
- Secondary amenorrhea
- Endometriosis
- Abnormal uterine bleeding caused by hormonal imbalance, after organic causes have been excluded
Treatment schedules vary by indication. The label generally describes short cyclic courses for amenorrhea and abnormal uterine bleeding, while endometriosis treatment may involve continuous administration at higher total exposure over time. Aygestin is not an estrogen-containing contraceptive and is not interchangeable with combined oral contraceptives on an indication-by-indication basis (U.S. Food and Drug Administration [FDA], n.d.-a).
How does Aygestin differ from norethindrone?
Norethindrone acetate is the acetate ester of norethindrone. In clinical practice, the two products are related but not commercially interchangeable without considering formulation, dose, labeling, and indication.
Norethindrone acetate 5 mg is commonly used for gynecologic indications requiring a higher progestin dose than that found in many contraceptive products. Norethindrone 0.35 mg products are generally marketed as progestin-only oral contraceptives. The different strengths and labeled uses create distinct prescription markets.
What is the FDA regulatory status of Aygestin?
Aygestin is a legacy FDA-approved product. The product is associated with NDA 016131 and has no remaining new chemical entity exclusivity or meaningful market exclusivity based on the age of its approval.
The FDA-approved brand label identifies norethindrone acetate tablets USP, 5 mg. Current commercial distribution may occur through successor companies, authorized distributors, or manufacturers using the same active ingredient under generic names. Product labeling and listing status can change as ownership, manufacturing, and distribution arrangements change (FDA, n.d.-a; National Library of Medicine, n.d.).
What is the Orange Book status of Aygestin?
The Orange Book is primarily relevant to approved drug products, therapeutic equivalence, patents, and exclusivity. Aygestin’s commercial position is consistent with a mature product whose core composition and original approval rights no longer create a material barrier to generic entry.
No current blockbuster-level Orange Book patent barrier is associated with the active ingredient or the conventional 5 mg tablet. Generic manufacturers can seek approval through abbreviated new drug applications when they satisfy bioequivalence, quality, manufacturing, and labeling requirements.
What patents protect Aygestin?
The original composition, formulation, and approval rights for norethindrone acetate tablets date back decades. Any patents that once covered the original product have expired or no longer provide commercially meaningful protection in the United States.
| Patent category | Current commercial relevance |
|---|---|
| Original active-ingredient protection | Expired |
| Original 5 mg tablet formulation protection | Expired or immaterial |
| New chemical entity exclusivity | Expired |
| Pediatric exclusivity | No material current relevance |
| Method-of-use patents | No known active barrier controlling ordinary use |
| Device or delivery-system patents | Not central to the conventional Aygestin tablet |
| Manufacturing patents | Potentially relevant to individual suppliers, but not a barrier to generic competition |
What formulations are protected by Aygestin patents?
The commercial product is a conventional immediate-release tablet. It does not depend on a proprietary depot system, transdermal platform, inhalation device, implant, or biologic manufacturing process. This limits the opportunity to use formulation patents to preserve pricing.
Individual suppliers may hold manufacturing know-how, process controls, or private-label arrangements. Those rights generally protect production economics or supply continuity rather than market exclusivity.
When does Aygestin lose exclusivity?
Aygestin lost effective exclusivity many years ago. Its commercial erosion occurred through the availability of generic norethindrone acetate tablets and through competition from other progestins and hormonal therapies.
The product has no meaningful remaining exclusivity period comparable to recently approved drugs. Generic substitution is therefore the default U.S. market condition, subject to state substitution laws, payer formularies, prescriber preference, and pharmacy inventory.
How many patents cover Aygestin?
No material active patent estate appears to control the core 5 mg norethindrone acetate tablet market. The relevant intellectual-property position is weak relative to recently launched specialty medicines.
A supplier may still have patents or trade secrets relating to:
- API purification
- Crystallization or particle control
- Tablet manufacturing
- Packaging
- Stability improvement
- Supply-chain processes
Those rights are unlikely to prevent competing manufacturers from selling standard norethindrone acetate tablets if alternative manufacturing routes are available.
Which companies are challenging Aygestin through Paragraph IV filings?
Aygestin is not a current Paragraph IV-centered market. Paragraph IV litigation is most important when a branded drug has unexpired Orange Book patents that delay or restrict generic approval. The core Aygestin product is already exposed to generic competition, making a new Paragraph IV campaign commercially unnecessary.
Generic companies compete through ANDA approvals and ordinary commercial substitution rather than through a high-value patent challenge against a protected brand. The competitive question is therefore supplier economics, manufacturing reliability, and formulary access.
What is the generic competition for Aygestin?
Generic norethindrone acetate 5 mg tablets are the main commercial substitute. The market includes products marketed under generic names and, depending on current distribution arrangements, branded or authorized-generic versions.
Relevant competitors include:
- Generic norethindrone acetate 5 mg tablets
- Medroxyprogesterone acetate
- Oral contraceptive regimens containing progestins
- Levonorgestrel-releasing intrauterine systems
- GnRH agonists and antagonists for selected endometriosis patients
- Danazol and other older hormonal therapies in limited circumstances
- Surgical treatment for structural causes of abnormal uterine bleeding
Norethindrone acetate retains clinical demand because it is oral, familiar to gynecologists, inexpensive relative to newer specialty therapies, and useful across several noncontraceptive indications.
How strong is the Aygestin patent estate?
The patent estate is weak as a source of commercial protection but irrelevant to the product’s continued clinical use. Aygestin’s value is based on established prescribing patterns and low-cost access rather than exclusivity.
| Value driver | Assessment |
|---|---|
| Patent protection | Low |
| Regulatory exclusivity | None of material commercial duration |
| Generic substitution risk | High |
| Clinical familiarity | High |
| Manufacturing complexity | Low to moderate |
| Pricing power | Low |
| Demand stability | Moderate |
| Brand differentiation | Limited |
| Litigation risk | Low |
| Supply-chain sensitivity | Moderate |
What patent litigation affects Aygestin?
No major current patent litigation is central to the Aygestin market. The product’s age and generic availability reduce the economic incentive for branded patent litigation.
Potential disputes would more likely involve:
- ANDA product quality or bioequivalence
- Manufacturing defects
- Trademark or trade-dress issues
- Distribution rights
- Contract manufacturing
- Product liability
- Supply agreements
These matters would affect individual suppliers but would not normally restore exclusivity to the Aygestin brand.
What licensing deals affect Aygestin?
Aygestin has passed through corporate ownership and commercial-distribution structures associated with legacy women’s-health portfolios. Warner Chilcott became part of Actavis through Actavis’s acquisition of Warner Chilcott in 2013. Actavis later combined with Allergan in 2015, creating a broader branded and generic pharmaceutical platform (Actavis plc, 2013; Allergan plc, 2015).
These transactions affected portfolio ownership and distribution. They did not create new patent protection for norethindrone acetate. Current product availability may depend on commercial agreements among the NDA holder, manufacturers, private-label distributors, and wholesalers.
What is the financial trajectory for Aygestin?
Aygestin’s financial trajectory is that of a mature, low-price prescription product:
- Original branded growth occurred before generic erosion.
- Generic entry reduced brand volume and price.
- Demand stabilized around chronic and episodic gynecologic use.
- Revenue shifted from branded economics toward low-margin generic and authorized-generic supply.
- Future growth is more likely to come from prescription-volume retention or supply capture than from price increases.
No public company separately reports Aygestin revenue in a way that supports a reliable standalone annual sales series. Brand-level revenue estimates from commercial databases may differ substantially because they depend on channel coverage, generic inclusion, prescription counting, and whether cash-pay transactions are captured.
What drives Aygestin demand?
The principal demand drivers are:
- Prevalence of endometriosis
- Evaluation and treatment of abnormal uterine bleeding
- Management of secondary amenorrhea
- Preference for oral therapy
- Lower cost versus newer endometriosis medicines
- Use as a temporary or cyclic progestin regimen
- Familiarity among obstetricians and gynecologists
The market does not depend on large specialty-pharmacy reimbursement or complex administration. Prescriptions can be filled through ordinary retail channels, which supports access but limits pricing leverage.
What limits Aygestin revenue?
Revenue is constrained by generic substitution, low tablet prices, multiple manufacturers, and competition from alternative hormonal treatments. Intermittent use also reduces annual prescription volume per patient compared with chronic therapies.
Commercial risks include:
- Generic price compression
- Loss of preferred formulary position
- Retail pharmacy substitution
- API or finished-dose shortages
- Limited brand marketing
- Prescriber migration to newer endometriosis therapies
- Changes in reimbursement for generic women’s-health products
What generic launch scenarios exist for Aygestin?
The most likely scenario is continued multi-source generic supply with low and stable pricing. A second scenario is intermittent supply disruption if manufacturers exit because of thin margins or quality problems. A third scenario is selective premium pricing for an authorized brand or reliable supplier during a shortage.
| Scenario | Probability profile | Commercial effect |
|---|---|---|
| Stable multi-source generic supply | Most likely | Low price, predictable access |
| Manufacturer consolidation | Plausible | Higher concentration and shortage sensitivity |
| Temporary supply interruption | Plausible | Short-term price and allocation pressure |
| Brand-led relaunch | Unlikely | Limited pricing power without differentiation |
| New formulation expansion | Unlikely for legacy Aygestin | Would require separate development and regulatory investment |
What manufacturing and IP barriers exist?
Manufacturing barriers are operational rather than patent-based. Norethindrone acetate tablets require compliance with current good manufacturing practices, validated processes, content uniformity, dissolution controls, impurity limits, packaging controls, and adequate API supply.
The product is less technically difficult than sterile injectables, biologics, controlled-release systems, or complex combination products. Its principal barriers are:
- API sourcing
- FDA manufacturing compliance
- Stability and dissolution performance
- Reliable batch release
- Commercial scale
- Distributor and wholesaler access
- Maintaining sufficient margins
A supplier with dependable production may gain share during shortages, but that advantage is usually temporary and does not create durable exclusivity.
How does Aygestin compare with newer endometriosis drugs?
Aygestin is less expensive and more familiar than newer oral GnRH therapies, but it has a different efficacy, tolerability, and monitoring profile. Newer agents may offer more targeted suppression of ovarian hormone activity and stronger commercial differentiation, while Aygestin remains attractive when cost and clinical familiarity dominate.
| Attribute | Aygestin | Newer oral endometriosis therapies |
|---|---|---|
| Active ingredient | Norethindrone acetate | GnRH antagonist or other newer agent |
| Administration | Oral tablet | Oral tablet |
| Patent protection | None of material value | Often active |
| Price | Low generic pricing | Higher branded pricing |
| Prescribing base | Broad gynecologic use | More specialty-oriented |
| Commercial risk | Generic erosion | Patent and reimbursement risk |
| Clinical positioning | Established progestin option | Targeted specialty treatment |
What biosimilar risk exists for Aygestin?
Biosimilar risk is not applicable. Aygestin is a small-molecule tablet, not a biologic. Its competitive threat comes from generic drugs, therapeutic substitutes, and manufacturer pricing rather than from biosimilar applicants.
What is the geographic coverage of Aygestin?
The strongest commercial relevance is in the United States, where Aygestin is an established prescription product and norethindrone acetate is widely recognized in gynecologic practice. International availability varies because regulatory approvals, brand names, strengths, indications, and market access differ by country.
Generic competition is generally more important than brand protection across developed pharmaceutical markets. In lower-income markets, supply continuity and local registration may matter more than patent status because the original protection has long expired.
Key Takeaways
- Aygestin is a legacy 5 mg norethindrone acetate tablet used for amenorrhea, endometriosis, and abnormal uterine bleeding.
- The product has no meaningful remaining U.S. market exclusivity.
- The core patent estate is expired or commercially immaterial.
- Generic norethindrone acetate is the primary competitive threat.
- Paragraph IV litigation is not central to the current market.
- Biosimilar risk does not apply because Aygestin is a small-molecule tablet.
- Revenue is not publicly disclosed on a standalone basis.
- Financial performance is driven by prescription persistence, generic pricing, supply reliability, and channel access.
- The strongest commercial opportunity lies in dependable generic supply, not in brand-led price expansion.
- The main risks are price compression, manufacturer exit, supply interruptions, and substitution by newer endometriosis therapies.
FAQs About Aygestin Market and Patent Status
Is Aygestin still commercially available?
Aygestin and generic norethindrone acetate products have been marketed in the United States, although specific brand availability can vary by distributor, manufacturer, and pharmacy inventory.
Can a generic manufacturer substitute norethindrone acetate for Aygestin?
Generic substitution generally depends on FDA therapeutic-equivalence status, state pharmacy law, prescriber instructions, and payer or pharmacy policy. The active ingredient, strength, dosage form, and approved labeling must be evaluated.
Does Aygestin have a 30-month patent litigation stay?
A 30-month stay is associated with qualifying Paragraph IV litigation involving unexpired listed patents. Aygestin’s mature, off-patent position does not create the typical current litigation framework associated with a recently launched branded drug.
Is norethindrone acetate used for contraception?
Norethindrone acetate 5 mg is primarily used for gynecologic conditions such as endometriosis, amenorrhea, and abnormal uterine bleeding. It should not be assumed to have the same contraceptive labeling or dosing as low-dose norethindrone contraceptive tablets.
Could Aygestin revenue increase despite generic competition?
A revenue increase is possible through prescription-volume growth, temporary supply shortages, distributor capture, or an authorized-generic strategy. Durable pricing expansion is unlikely without a differentiated formulation, new indication, or supply constraint.
References
Actavis plc. (2013). Actavis to acquire Warner Chilcott in a tax-efficient, stock-for-stock transaction. Company announcement.
Allergan plc. (2015). Actavis completes acquisition of Allergan. Company announcement.
National Library of Medicine. (n.d.). DailyMed: Norethindrone acetate tablet labeling. U.S. National Library of Medicine.
U.S. Food and Drug Administration. (n.d.-a). Aygestin (norethindrone acetate) tablets, USP, 5 mg: Prescribing information. Drugs@FDA.
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations. Orange Book.
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