DEMULEN 1/35-28 Drug Patent Profile

Which patents cover Demulen 1/35-28, and what generic alternatives are available?

Demulen 1/35-28 is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in DEMULEN 1/35-28 is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.

Summary for DEMULEN 1/35-28

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DEMULEN 1/35-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gd Searle Llc	DEMULEN 1/35-28	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	018160-001	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for DEMULEN 1/35-28

See the table below for patents covering DEMULEN 1/35-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	268250
Netherlands	6511785
Japan	S5118419
Switzerland	476679	Verfahren zur Herstellung neuer ungesättigter Amine
Netherlands	130749

Supplementary Protection Certificates for DEMULEN 1/35-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

DEMULEN 1/35-28: Investment Scenario and Fundamentals Analysis

Last updated: April 24, 2026

What is DEMULEN 1/35-28, and how is it positioned commercially?

DEMULEN 1/35-28 is a combined oral contraceptive product (COC) delivering ethinyl estradiol 35 mcg and norethindrone acetate 1 mg, taken on a 28-day cycle with the typical formulation pattern used in “1/35” branded COCs. The product is sold as a branded contraceptive category drug within a mature, highly competitive U.S. oral contraception market.

Core investment implication: DEMULEN 1/35-28 sits in a segment dominated by (1) long-standing generics, (2) payer-driven formulary decisions, and (3) high channel leverage from large generic and brand incumbents. This is a “distribution and access” story more than an “R&D pipeline” story.

What are the product fundamentals (regulatory, exclusivity, and lifecycle signals)?

Regulatory status and IP posture for mature branded oral contraceptives typically maps to a low R&D cost profile for manufacturing continuity but limited defensibility via patents against established generics. DEMULEN 1/35-28 is a known legacy contraceptive product; for an investment thesis, the key fundamentals are:

• Patent exclusivity: generally not expected to provide long-duration incremental protection in late lifecycle COCs (many entrants rely on established chemistry and formulation rather than novel MoA).
• Pricing power: structurally constrained by generic substitution and PBM rebate dynamics for oral contraception.
• Volume leverage: tied to plan design (tier placement, prior authorization rules in some cases, preferred brand lists, and national drug codes held by payers).

Investment implication: Expect limited near-term upside from clinical differentiation. Returns are more likely driven by formulary retention, contracting outcomes, and channel continuity.

How does market structure shape DEMULEN’s revenue resilience?

The U.S. COC market is large and mature. Competitive pressure is driven by:

• Generic substitution at the pharmacy level.
• Formulary steering by PBMs and national accounts.
• Medical necessity constraints (where present) that can shift access but usually do not create durable exclusivity unless a product is preferred and effectively managed.

In this framework, DEMULEN 1/35-28’s resilience depends on whether it remains a credible contracting alternative for:

• members unable to tolerate certain products,
• formulary “coverage of brands” within a class,
• and plans that maintain a small number of branded COCs for adherence or patient stability.

What is the demand driver profile for this product class?

Demand drivers for combined oral contraception include:

• Persistent population-level demand for contraception.
• High adherence dependence on tolerability and patient continuity.
• Switching costs that arise from perceived side effects, bleeding patterns, and regimen experience.

This means DEMULEN’s demand is not purely elastic to price. In mature markets, a branded product can retain share when it meets patient-specific tolerability profiles, but it still competes against cheaper generic alternatives.

What does the “1/35-28” formulation imply for competitive differentiation?

The formulation naming indicates:

• 1 mg norethindrone acetate
• 35 mcg ethinyl estradiol
• 28-day cycle

For investors, the implication is that DEMULEN competes on the patient experience profile for this specific estrogen-progestin combination rather than on a novel mechanism. In competitive COC classes, that typically results in:

• limited defensibility,
• reliance on brand trust,
• and contract-specific competitiveness.

How do typical payer and pharmacy economics affect returns?

In the U.S., branded oral contraceptives often operate in a tradeoff:

• Higher manufacturer net cost for rebates and contracting
• Reduced gross price due to PBM negotiating leverage
• Still meaningful margin contribution if the product holds favorable plan placement

For DEMULEN 1/35-28, the investment question becomes whether the net economics support:

• maintaining shelf share,
• defending placement in preferred brand subsets, and
• avoiding aggressive downward pressure from generic-only strategies by payers.

What are the risk factors that directly hit the investment case?

Key risks for a legacy branded COC include:

1. Formulary displacement risk
   • PBMs periodically revise preferred lists and can shift to generics or competitor brands.
2. Channel pricing compression
   • branded COCs are highly sensitive to rebate and net price adjustments.
3. Generic expansion and competitive dynamics
   • even when a product holds share, additional generic entrants can accelerate price pressure.
4. Regulatory and labeling changes
   • any changes affecting contraceptive safety language or prescribing guidance can shift demand patterns and payer policies.

What upside exists, and where could incremental value come from?

For a mature product like DEMULEN 1/35-28, upside is most often operational:

• Stronger-than-expected formulary retention across major commercial and government plans.
• Improved contracting outcomes that sustain or raise net price.
• Share recovery due to supply continuity or better patient tolerability narratives in managed care.

Unlike pipeline assets, the upside is not driven by clinical trial breakthroughs. It is driven by contracting execution and maintaining access.

How does this compare to higher-growth contraception segments?

From an investment standpoint, compare DEMULEN to segments with more disruptive dynamics:

• Long-acting reversible contraception (LARC): often shifts share away from oral methods, depending on policy and access.
• Newer branded COCs and specialty regimens: may secure better formulary placement with differentiated patient segmentation.

DEMULEN is structurally exposed to these dynamics, so its investment profile should be treated as:

• steadier cash flow potential with limited growth torque,
• higher sensitivity to payer decisions,
• and lower likelihood of step-change in revenue absent access improvement.

What is the investment scenario most consistent with DEMULEN’s profile?

A realistic scenario is a defensive branded legacy asset:

• Objective: preserve net sales via payer placement and pharmacy channel stability.
• Thesis driver: continued inclusion in formularies where clinician and patient continuity matters.
• Return profile: moderate and driven by price net of rebates, not by rapid volume growth.

The risk-adjusted framing favors investors seeking cash flow durability rather than high upside.

What fundamentals would you track to underwrite the thesis (KPIs)?

Because the product’s value hinges on market access, underwriting should focus on:

• Net price trend (rebates and contracting pressure)
• Formulary coverage across top PBMs and major plan types
• Prescription share vs. the closest generic and branded alternatives
• Channel continuity (availability and distribution reliability)
• Switching rates in therapy classes (COC)
• Formulation-level demand shifts within “1/35” style products

Key Takeaways

• DEMULEN 1/35-28 is a mature branded combined oral contraceptive positioned in a highly price- and formulary-driven market.
• Investment upside is constrained by generic competition and limited IP defensibility typical of legacy COCs; value is more likely tied to payer contracting and formulary retention than to clinical differentiation.
• Primary risks are formulary displacement, rebate-driven net price compression, and share erosion to generics or other contraception modalities.
• Most consistent scenario: a defensive cash-flow asset with underwriting centered on net price, plan coverage, prescription share, and contracting economics.

FAQs

1) Is DEMULEN 1/35-28 protected by long-term exclusivity?
No long-duration exclusivity is expected for a legacy branded COC; practical defensibility is primarily formulary and contracting based, not patent-based.

2) What determines whether DEMULEN maintains revenue?
Payer placement, rebate economics, and patient continuity. Pharmacy-level demand can persist, but net revenue depends on contracting outcomes.

3) What is the biggest commercial threat to DEMULEN?
Aggressive formulary steering toward generics and shifts in PBM preferred lists within the COC category.

4) Does DEMULEN have meaningful differentiation versus generics?
Differentiation is mainly patient experience tied to the specific estrogen-progestin combination and regimen, not a novel mechanism.

5) How should investors model growth for DEMULEN?
Model limited organic growth with returns driven by retention of access, stable supply, and net price maintenance rather than rapid demand expansion.

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug label / prescribing information for DEMULEN 1/35-28 (ethinyl estradiol and norethindrone acetate). FDA accessdata.