CRYSELLE Drug Patent Profile

Which patents cover Cryselle, and when can generic versions of Cryselle launch?

Cryselle is a drug marketed by Duramed Pharms Barr and is included in one NDA.

The generic ingredient in CRYSELLE is ethinyl estradiol; norgestrel. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for CRYSELLE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	684
Drug Sales Revenues:	Drug sales revenues for CRYSELLE
DailyMed Link:	CRYSELLE at DailyMed

US Patents and Regulatory Information for CRYSELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840-001	Nov 30, 2001	AB	RX	No	No
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-28	075840-002	Nov 30, 2001	AB	RX	No	Yes

Cryselle Market Dynamics and Financial Trajectory

Last updated: August 3, 2026

Cryselle is a mature combined oral contraceptive containing norgestrel 0.3 mg and ethinyl estradiol 0.03 mg. Its commercial outlook is driven by generic pricing, pharmacy substitution, payer formularies, distributor access and manufacturing reliability rather than patent exclusivity. Public filings do not separately disclose Cryselle revenue, so its financial trajectory must be assessed through product positioning, prescription economics and the competitive market for combined oral contraceptives.

What is Cryselle and who markets it?

Cryselle-28 is a 28-tablet oral contraceptive. Each active tablet contains norgestrel 0.3 mg and ethinyl estradiol 0.03 mg; the package includes 21 active tablets and seven inert tablets.[1]

Attribute	Cryselle-28
Active ingredients	Norgestrel and ethinyl estradiol
Strength	0.3 mg / 0.03 mg
Dosage form	Oral tablet
Pack format	28 tablets
Therapeutic category	Combined hormonal contraceptive
FDA regulatory pathway	Abbreviated New Drug Application, or legacy oral-contraceptive approval framework, depending on listing
Primary use	Prevention of pregnancy
Current commercial model	Generic or multisource prescription product
Product-level revenue disclosure	Not separately reported publicly

Cryselle is associated with G&W Laboratories in U.S. product labeling and distribution records.[1] Manufacturing and supply arrangements can change by lot, contract manufacturer or distributor, so the labeler, marketer and physical manufacturer should be distinguished in commercial diligence.

Cryselle competes with other norgestrel/ethinyl estradiol products and with a much broader set of oral contraceptives containing levonorgestrel, norethindrone, desogestrel, drospirenone and other progestins.

What is the FDA status of Cryselle?

Cryselle is an FDA-approved prescription contraceptive. Its labeling contains the standard safety information for estrogen-containing contraceptives, including thrombotic and cardiovascular risks, contraindications involving certain smokers and patients with thromboembolic risk factors, and drug-interaction warnings.[1]

The principal regulatory characteristics are:

• Prescription-only status.
• Oral tablet dosage form.
• No biologic component.
• No biosimilar pathway.
• No new chemical entity exclusivity.
• Generic-market substitution and formulary access as the primary commercial determinants.

Cryselle is not a biologic and therefore does not face biosimilar competition. The relevant competitive threat is generic and branded-generic substitution among combined oral contraceptives.

What patents protect Cryselle?

Cryselle’s commercial position is not based on a current composition-of-matter patent estate. Norgestrel and ethinyl estradiol are long-established active ingredients, and the product has been marketed for decades.

IP category	Cryselle position	Commercial effect
Active-ingredient patent	No meaningful current protection expected	Does not block generic competition
New chemical entity exclusivity	Expired or not commercially relevant	No exclusivity premium
Basic formulation patent	No publicly significant current barrier identified	Limited ability to prevent substitution
Method-of-use patent	No publicly significant current barrier identified for contraception	Does not materially restrict competing products
Manufacturing patent	Potentially relevant only to a specific supplier process	Usually does not protect the finished product market
Orange Book-listed patent	Requires current FDA Orange Book verification by product listing	Any listed patent would need separate legal review

The Orange Book is the controlling reference for FDA-listed patents and regulatory exclusivity, but an Orange Book listing does not establish that a patent is enforceable or commercially blocking.[2] For a mature product such as Cryselle, the main patent risk is usually associated with manufacturing, supply or private contractual rights rather than market exclusivity.

When did Cryselle lose exclusivity?

Cryselle is effectively a post-exclusivity product. Its active ingredients and dosage form have been available for many years, and the market has multiple therapeutic substitutes.

The practical loss of exclusivity occurred through the cumulative entry of:

1. Other norgestrel/ethinyl estradiol products.
2. Equivalent combined oral contraceptives using different progestins.
3. Pharmacy-level generic substitution.
4. Low-cost oral contraceptive programs and payer-preferred products.
5. Non-oral contraceptives, including implants, intrauterine systems, injections, patches and vaginal rings.

The product therefore has no realistic exclusivity-driven pricing phase. Revenue depends on prescription volume multiplied by a low net price, less wholesaler discounts, rebates, returns and distribution costs.

How does Cryselle compare with competing contraceptives?

Cryselle’s main weakness is that its formulation is mature and undifferentiated. Its main strength is familiarity, established labeling and availability through the retail pharmacy channel.

Product group	Competitive relationship to Cryselle	Pricing and market effect
Norgestrel/ethinyl estradiol generics	Direct substitutes	Highest substitution pressure
Levonorgestrel/ethinyl estradiol products	Close therapeutic substitutes	Broadens payer and prescriber alternatives
Norethindrone/ethinyl estradiol products	Alternative combined pills	Supports low-cost formulary competition
Drospirenone-containing pills	Differentiated branded and generic alternatives	May retain price premiums in selected segments
Long-acting reversible contraceptives	Non-oral alternatives	Reduces dependence on daily oral pills
Emergency contraception	Different use case	Not a direct substitute
Progestin-only pills	Alternative for estrogen-contraindicated patients	Expands treatment choice and reduces addressable demand

Cryselle does not have an obvious delivery-system advantage, extended-release profile or proprietary patient-support platform. That limits its capacity to command a premium over therapeutically similar products.

What drives Cryselle market demand?

Demand is relatively defensive because contraception is a recurring healthcare need, but product-level demand is sensitive to channel and policy changes.

Prescription volume

The largest volume drivers are:

• Number of reproductive-age patients using oral contraception.
• Continuation rates for daily pills.
• Prescriber preference for established generic formulations.
• Availability through retail, mail-order and public-sector channels.
• State and federal contraceptive coverage policies.

Cryselle’s volume can remain stable even when prices decline, provided the product retains formulary placement and reliable supply.

Payer and pharmacy substitution

Pharmacy benefit managers and health plans commonly favor the lowest-net-cost equivalent. A product may lose prescriptions even without a clinical disadvantage if a competing manufacturer offers better rebates or more consistent inventory.

For Cryselle, substitution risk is structurally high because:

• The product has no strong patent barrier.
• Several equivalent or near-equivalent pills are available.
• The active ingredients are well understood.
• Patients and prescribers can switch with limited clinical friction in many cases.
• Pharmacies can dispense a preferred generic under state substitution rules and payer contracts.

Supply reliability

Supply continuity is a material commercial variable. Oral contraceptive shortages can result from active pharmaceutical ingredient constraints, packaging problems, quality investigations, contract-manufacturing changes or distributor inventory policies.

A small product can gain temporary share during a competitor shortage, but the gain may reverse once supply normalizes. Sustained share requires stable manufacturing, FDA-compliant quality systems and adequate wholesaler inventory.

What is the financial trajectory for Cryselle?

Cryselle’s financial trajectory is best characterized as mature, low-growth and price-sensitive.

Financial driver	Likely direction	Effect on product economics
Unit demand	Stable to modestly declining	Contraceptive demand is recurring, but substitution is extensive
Net price	Downward or flat	Generic competition and payer pressure constrain pricing
Gross margin	Under pressure	Rebates, channel costs and manufacturing inflation reduce margin
Revenue volatility	Moderate	Shortages and contract changes can cause temporary swings
R&D expense	Minimal at product level	No evident need for clinical innovation to sustain the product
Regulatory expense	Recurring but manageable	Label maintenance, pharmacovigilance and quality compliance remain necessary
Capital intensity	Low to moderate	Dependent on manufacturing ownership and supplier arrangements
Long-term growth	Limited	Growth would require share capture, supply disruption or channel expansion

A simple product-level model is:

Revenue = dispensed prescriptions x net revenue per prescription

For a mature generic, the second variable is usually the weaker component. Even if prescription volume is stable, lower acquisition cost, rebate competition and pharmacy switching can reduce net sales. If the product loses preferred status, volume and price can decline simultaneously.

Public company filings generally aggregate generic oral contraceptive sales within broader portfolios. Cryselle revenue is therefore unlikely to be visible as a standalone line item unless disclosed by the private or specialty marketer. No reliable public basis exists for assigning a precise annual revenue figure to Cryselle.

Does Cryselle face Paragraph IV litigation?

Cryselle is not a typical current Paragraph IV litigation target. Paragraph IV litigation usually arises when a generic applicant challenges an unexpired patent listed for a branded reference product. Cryselle itself is an established generic-market product rather than a newly patented branded product with a meaningful remaining exclusivity period.

Relevant litigation risks are more likely to involve:

• FDA approval or labeling disputes.
• Manufacturing quality actions.
• Contract disputes between the marketer and supplier.
• Product liability claims associated with estrogen-containing contraception.
• Antitrust or pricing investigations affecting generic suppliers.
• Patent disputes involving a competing formulation or manufacturing process.

The absence of a material Paragraph IV threat does not eliminate commercial risk. For Cryselle, substitution and supply competition are more important than patent litigation.

What formulation patents protect Cryselle?

No commercially significant formulation patent position is evident from the product’s mature market profile. Cryselle is a conventional immediate-release tablet rather than a differentiated extended-release, transdermal or implantable system.

Potentially protectable technical elements could include:

• Tablet composition.
• Excipient selection.
• Coating or dissolution characteristics.
• Manufacturing process parameters.
• Stability and packaging configurations.
• Analytical methods.

These rights would generally protect a particular manufacturing process or presentation, not the contraceptive market as a whole. Competitors could often design around narrow process claims while continuing to market an equivalent active-ingredient combination.

What manufacturing and IP barriers affect Cryselle?

The main barriers are operational rather than patent-based.

Manufacturing barriers

A supplier must maintain:

• FDA-compliant current good manufacturing practice systems.
• Validated tablet production and packaging.
• Adequate stability data.
• Controlled sourcing of active ingredients.
• Reliable quality testing and batch release.
• Pharmacovigilance and complaint-handling systems.

Because the product has limited differentiation, a quality event can have an outsized effect on supply and customer retention. Wholesalers and pharmacies have limited tolerance for repeated back orders.

Intellectual-property barriers

IP barriers are likely to be low for the finished product. A competitor would face greater practical obstacles from FDA filing requirements, manufacturing validation and commercial scale-up than from a blocking Cryselle patent.

What generic launch scenarios exist for Cryselle?

Base case: stable low-price maintenance

Cryselle retains a recurring prescription base while competing on availability and price. Revenue is flat to modestly lower, and margins remain constrained.

Downside case: formulary displacement

A competing manufacturer offers a lower net price or secures preferred payer status. Pharmacies substitute away from Cryselle, reducing both volume and revenue.

Supply-disruption case: temporary share gain

A competing product experiences a shortage. Cryselle captures incremental prescriptions, but the benefit fades when the competitor returns.

Consolidation case: channel rationalization

A distributor or marketer reduces support for the product because contribution margins are too low. Cryselle remains approved but becomes less visible or less consistently stocked.

Upside case: targeted public-sector or mail-order access

The product gains volume through a government, clinic or mail-order contract. The revenue benefit depends on contract pricing and manufacturing capacity, so higher volume may not produce proportionate profit growth.

What is the geographic market for Cryselle?

Cryselle’s commercially relevant market is primarily the United States. FDA approval, U.S. labeling and U.S. Orange Book treatment determine domestic market access.[1,2]

International markets may contain equivalent norgestrel/ethinyl estradiol products under different brand names, sponsors and regulatory approvals. Cryselle’s U.S. brand recognition does not automatically create rights outside the United States. Geographic expansion would require local registration, supply arrangements, pharmacovigilance systems and reimbursement access.

The United States remains the most relevant market for assessing Cryselle’s commercial performance because the product’s identity, labeling and distribution are tied to U.S. regulatory and pharmacy channels.

How strong is the Cryselle patent estate?

Cryselle has a weak patent-based competitive position but a potentially durable operational position.

Factor	Assessment
Composition-of-matter protection	Weak or expired
Formulation differentiation	Limited
Method-of-use protection	Limited
Biosimilar exposure	None
Paragraph IV exposure	Low as a current product-specific issue
Generic substitution risk	High
Supply-chain dependence	Material
Brand loyalty	Limited relative to differentiated contraceptives
Pricing power	Low
Regulatory durability	High, subject to continued compliance
Overall commercial strength	Moderate only if supply and channel access remain reliable

Key Takeaways

• Cryselle is a mature combined oral contraceptive containing norgestrel and ethinyl estradiol.
• Its market position depends on price, pharmacy access, payer preference and supply reliability.
• Patent exclusivity is not the basis of its commercial value.
• Product-level revenue is not separately disclosed in public filings.
• The expected financial profile is stable to declining revenue with persistent pricing pressure.
• Cryselle faces high substitution risk from equivalent generics and alternative oral contraceptives.
• Biosimilar risk is irrelevant because Cryselle is a small-molecule tablet.
• Paragraph IV litigation is not the central competitive risk.
• Manufacturing quality, inventory continuity and contracting strategy are more important than formulation IP.
• Any temporary revenue increase from a competitor shortage is likely to be reversible.

FAQs About Cryselle Market and Financial Risk

Is Cryselle still commercially viable?

Yes. Its viability comes from recurring contraceptive demand, established FDA labeling and retail pharmacy distribution. Its low pricing power limits profitability.

Is Cryselle the same as a generic birth-control pill?

Cryselle is a specific combined oral contraceptive formulation. Other generic birth-control pills may contain different progestins or estrogen doses and are not necessarily therapeutically identical products.

Can pharmacies automatically substitute another contraceptive for Cryselle?

Substitution depends on product equivalence, state law, payer rules and prescriber instructions. A pharmacy cannot treat every oral contraceptive as interchangeable solely because the products prevent pregnancy.

Is Cryselle exposed to the loss of patent exclusivity?

The product is already positioned in a post-exclusivity market. Its main exposure is ongoing generic price competition, not a future patent cliff.

Could Cryselle revenue increase without a price increase?

Yes. Revenue could rise through higher prescription volume, public-sector contracts, mail-order access or temporary competitor shortages. Profit would still depend on rebates, manufacturing cost and distribution terms.

References

1. U.S. Food and Drug Administration. (n.d.). Cryselle-28: Norgestrel and ethinyl estradiol tablets prescribing information. DailyMed.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
3. U.S. Food and Drug Administration. (n.d.). Drug approvals and databases. FDA.
4. Centers for Disease Control and Prevention. (2024). Contraception and birth control methods. U.S. Department of Health and Human Services.