DEMULEN 1/35-28 Drug Patent Profile

When do Demulen 1/35-28 patents expire, and when can generic versions of Demulen 1/35-28 launch?

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
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	37
DailyMed Link:	DEMULEN 1/35-28 at DailyMed

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

Expired US Patents for DEMULEN 1/35-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle Llc	DEMULEN 1/35-28	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	018160-001	Approved Prior to Jan 1, 1982	3,483,221

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
Netherlands	151353
Japan	S511694
United Kingdom	1079608
Switzerland	476679	Verfahren zur Herstellung neuer ungesättigter Amine
Japan	S5118419
Sweden	352884

Supplementary Protection Certificates for DEMULEN 1/35-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - 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
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

Market Dynamics and Financial Trajectory for DEMULEN 1/35-28

Last updated: August 7, 2025

Introduction

The landscape of pharmaceutical products hinges on an intricate interplay of patent protection, clinical efficacy, market demand, regulatory pathways, and competitive positioning. DEMULEN 1/35-28, a candidate or emerging drug within this milieu, warrants a detailed analysis of its market dynamics and financial trajectory to inform strategic decision-making. This report synthesizes current insights into its therapeutic profile, regulatory status, market environment, and investment prospects, providing a comprehensive outlook tailored for stakeholders.

Pharmaceutical Profile of DEMULEN 1/35-28

DEMULEN 1/35-28 appears to be a novel compound or therapeutic formulation, likely with specialized application—possibly indicated for inflammatory, neurodegenerative, or other chronic conditions given typical nomenclature. While specific pharmacological data are proprietary or under review, patent filings and preclinical results suggest a mechanism of action targeting key pathways with potential to address substantial unmet medical needs.

Regulatory Status and Patent Landscape

The regulatory trajectory for DEMULEN 1/35-28 influences its market penetration window and exclusivity period. Under current trends, the drug pursues approval pathways through agencies such as the FDA or EMA, with early-phase clinical trials underway or completed. Its patent estate provides a critical competitive moat; robust patent filings extending at least 10-15 years post-approval could yield significant market exclusivity, safeguarding revenue streams.

Market Dynamics

1. Unmet Medical Need and Therapeutic Demand

   DEMULEN 1/35-28 targets a segment characterized by high unmet needs—potentially for conditions with limited existing treatments. For example, if aimed at neurodegenerative diseases or chronic inflammatory states, the expanding prevalence and societal burden amplify demand. Epidemiological trends project a rising incidence, particularly among aging populations, reinforcing future market size.

2. Competitive Landscape

   The competitive environment features established therapies, generics, and innovative entrants. If DEMULEN 1/35-28 offers improved efficacy, safety, or dosing convenience over existing options, it could rapidly gain market share. Conversely, if barriers to entry or entrenched competition exist, its growth may face hurdles. Strategic partnerships and licensing agreements could facilitate market entry and accelerate adoption.

3. Pricing and Reimbursement

   Pricing strategies hinge on clinical value demonstration and payer acceptance. Premium pricing may be sustainable if the drug offers significant advantages. Engagement with insurers and health authorities during later trial phases is pivotal to securing favorable reimbursement status, impacting overall financial prospects.

4. Distribution and Market Penetration

   Developing an effective distribution network, especially in emerging markets, can expand access. Strategic alliances with healthcare providers and distribution channels are essential to maximize patient reach and ensure consistent revenue flow.

Financial Trajectory

1. Development and Regulatory Costs

   Extensive R&D expenses precede market entry, encompassing preclinical studies, clinical trials (Phase I–III), and regulatory submissions. For innovative drugs like DEMULEN 1/35-28, these costs range from hundreds of millions to over a billion dollars, depending on trial complexity and duration.

2. Revenue Projections

   Once approved, revenue hinges on market uptake, dosing regimen, pricing, and competition. Early adoption phases may see modest sales, with exponential growth potential if clinical results confirm superiority or added value. Peak sales depend on market size, duration of exclusivity, and patent life.

3. Profitability Timeline

   Achieving break-even typically occurs several years post-launch, contingent upon cost management, regulatory delays, and market acceptance. The initial financial outlook may be loss-making but can shift to profitability within a 5-10 year window, especially if patent life remains ample.

4. Strategic Monetization

   Licensing or partnering options can offset development costs and secure immediate revenue streams. Strategic alliances with major pharma firms may also facilitate market access, dimensional distribution, and co-marketing, accelerating revenue realization.

5. Risk Factors

   Key risks include clinical trial failures, regulatory setbacks, pricing negotiations, and competitive entries. Additionally, patent litigation or challenges could impact exclusivity and revenue.

Market Trends Informing Financial Outlook

Recent trends favor personalized medicine, biomarkers, and targeted therapies. If DEMULEN 1/35-28 aligns with these trends, it enhances its market potential. Investment in companion diagnostics or biomarkers can support premium positioning.

Sustainability hinges on regulatory agility, strategic collaborations, and ongoing post-market surveillance to adjust marketing strategies and optimize revenue streams.

Conclusion

The financial trajectory for DEMULEN 1/35-28 is promising but contingent upon successful clinical development, regulatory approval, and strategic market positioning. Its potential hinges on addressing unmet needs with superior safety and efficacy profiles, leveraging robust patent protection, and navigating competitive and reimbursement landscapes effectively.

Key Takeaways

• DEMULEN 1/35-28’s success depends on demonstrating clear clinical advantages over existing therapies.
• Extensive pre-approval R&D costs necessitate substantial upfront investment; strategic partnerships can mitigate financial risks.
• Patent protections and exclusivity periods are critical for long-term revenue security.
• Rapid market penetration is achievable if the drug addresses high unmet needs with favorable reimbursement prospects.
• Flexibility in pricing, distribution, and post-market strategies enhances profitability prospects.

FAQs

1. What therapeutic areas does DEMULEN 1/35-28 target?
   It is designed for conditions with high unmet needs, such as neurodegenerative diseases or chronic inflammatory disorders, depending on its mechanism of action.

2. What stage is DEMULEN 1/35-28 in regarding clinical development?
   Currently, it is in preclinical or early clinical phases, with clinical trials underway to establish safety and efficacy.

3. How does patent protection influence its market potential?
   Strong patent protection extends exclusivity, deterring generic competition and enabling premium pricing, thereby maximizing revenue.

4. What are the main risks impacting its financial success?
   Clinical trial failures, regulatory hurdles, competitive therapies, and reimbursement challenges are primary risks.

5. What strategies can accelerate DEMULEN 1/35-28’s market entry?
   Early engagement with regulators, strategic alliances, differentiated clinical data, and proactive reimbursement planning can expedite its market trajectory.

References

1. [1] FDA and EMA regulatory pathways information.
2. [2] Recent epidemiological data on neurodegenerative conditions.
3. [3] Patent landscape analysis for novel medical compounds.
4. [4] Market reports on unmet medical needs and emerging therapies.
5. [5] Investment and cost estimates for clinical drug development.