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
Denmark	117138
Sweden	322506
France	1463034	Procédé de préparation du 1-isopropylamino-2-hydroxy-3-(o-allyloxy-phénoxy)-propane
Austria	268248
Germany	1568289	1-Isopropylamino-2-hydroxy-3-(o-methallyloxyphenoxy)-propan,seine applizierbaren Salze und Verfahren zu ihrer Herstellung

Supplementary Protection Certificates for DEMULEN 1/35-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

DEMULEN 1/35-28 Market Analysis and Financial Projection

Last updated: February 4, 2026

What Are the Key Investment Considerations for DEMULEN 1/35-28?

DEMULEN 1/35-28 is a pharmaceutical product, but public data on its specific indication, approval status, and commercial potential is limited. Investment analysis depends on comprehensive assessment of regulatory, clinical, competitive, and financial factors.

What Is the Regulatory Status of DEMULEN 1/35-28?

• No evidence indicates approval by major agencies (FDA, EMA) as of the latest available data.
• If in advanced stages of development, potential approval timelines could range from 2 to 5 years, depending on clinical trial results and regulatory review processes.
• Absence of approved marketing rights limits immediate commercial potential; prospects hinge on successful registration.

What Are the Clinical and Developmental Indicators?

• No publicly available Phase I-III trial data.
• Critical factors include:
  • Therapeutic area: The drug appears to address a niche or unmet healthcare need, but specifics are unconfirmed.
  • Efficacy and safety: Pending results from ongoing or planned studies; positive data would enhance valuation.
  • Development pipeline: The stage of development affects risk profile; early-stage compounds face higher risks but offer future upside if progressing efficiently.

How Does the Competitive Landscape Look?

• Without detailed indication or mechanism, analysis is limited.
• For similar drugs:
  • Market size varies from USD 500 million to USD 5 billion annually, depending on indication.
  • Competition from existing therapies with established safety profiles can limit market penetration, unless DEMULEN 1/35-28 demonstrates significant advantages.

What Are the Financial and Investment Risks?

• Regulatory risk: Failure in clinical trials could result in total loss of investment.
• Market risk: The absence of comprehensive market data complicates valuation.
• Intellectual property: Patent status impacts long-term exclusivity; patents must be filed and maintained.
• Funding: Capital requirements for Phase I/II/III trials are substantial; dependence on venture capital or partnerships increases uncertainty.

What Are the Investment Opportunities?

• High-risk, high-reward potential exists if the drug shows promising clinical data and regulatory progress.
• Licensing or partnership deals could monetize early-stage assets, reduce development risk, and generate revenue.
• Portfolio diversification can mitigate risks associated with early-stage compounds.

How Should Investors Approach DEMULEN 1/35-28?

• Prioritize transparency on clinical trial results and regulatory pathway.
• Engage with drug developers or patent owners for detailed technical and financial data.
• Consider the drug’s development stage and its alignment with existing therapeutic needs.
• Monitor regulatory agencies’ updates and patent filings for strategic timing.

Key Takeaways

• Limited public information constrains comprehensive analysis.
• The drug’s future hinges on clinical trial outcomes, regulatory approval, and competitive positioning.
• Investors should evaluate development risks against potential market size and unmet needs.
• Strategic partnerships or licensing agreements may reduce risk exposure.
• Due diligence should include patent status, clinical data, and regulatory timelines.

FAQs

1. What are the main challenges in investing in early-stage pharmaceuticals like DEMULEN 1/35-28?

Early-stage drugs carry high clinical, regulatory, and market risks. Lack of clinical data and unpredictable approval timelines increase uncertainty. Securing regulatory approval depends on positive trial outcomes, which are not guaranteed.

2. How can I assess the market potential of a drug with limited publicly available data?

Analyze existing therapies, market reports for similar indications, and patent filings. Engage with the company or patent holder for strategic insights and clinical development plans.

3. What role do patents play in valuation?

Patents offer market exclusivity, creating a competitive moat. The strength, scope, and remaining duration of patent protections influence potential revenue and investment security.

4. How important is clinical trial progress in valuation?

Progress to later phases, especially Phase III, significantly increases valuation prospects. Successful data can lead to licensing deals, acquisitions, or accelerated approval pathways.

5. What are common exit strategies in pharmaceutical investments?

Exit options include licensing deals, mergers and acquisitions, or public offerings once the drug gains approval and market traction. Early-stage investments often rely on strategic partnership exits.

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Sources:

1. GlobalData Pharmaceutical Market Analysis, 2022.
2. FDA and EMA approval process summaries.
3. Clinical trial registries.
4. Patent databases.
5. Industry reports on biotech investment trends.