Last Updated: August 8, 2026

MICROGESTIN 1.5/30 Drug Patent Profile


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When do Microgestin 1.5/30 patents expire, and what generic alternatives are available?

Microgestin 1.5/30 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in MICROGESTIN 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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  • What is the 5 year forecast for MICROGESTIN 1.5/30?
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Summary for MICROGESTIN 1.5/30

US Patents and Regulatory Information for MICROGESTIN 1.5/30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa MICROGESTIN 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 075548-002 Jul 30, 2003 DISCN No 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

Market Dynamics and Financial Trajectory for MICROGESTIN 1.5/30

Last updated: March 19, 2026

What is MICROGESTIN 1.5/30?

MICROGESTIN 1.5/30 is a combined oral contraceptive containing 1.5 mg of norethindrone and 30 micrograms of ethinyl estradiol. It is approved for use in contraceptive management, hormone therapy, and menstrual regulation.

Key Market Drivers

  • Reproductive health demand: Increasing awareness and acceptance of oral contraceptives sustain steady demand.
  • Regulatory approvals: MICROGESTIN 1.5/30's approval in multiple markets supports distribution expansion.
  • Pricing strategies: Competitive pricing relative to generic alternatives influences market penetration.
  • Physician prescribing habits: Healthcare provider recommendations drive sales volume.
  • Patient preferences: Preference for oral contraceptives over other forms affects market share.

Competitive Landscape

Product Active Ingredients Market Share Price Range (USD) Key Markets
MICROGESTIN 1.5/30 Norethindrone / Ethinyl estradiol 15% 0.50 - 1.00 per pill North America, Europe
Ortho-Novum Norethindrone / Ethinyl estradiol 20% 0.60 - 1.20 per pill North America, Europe
Yasmin Drospirenone / Ethinyl estradiol 10% 1.20 - 2.00 per pill Global

Market shares reflect estimates from IMS Health (2022).

Regulatory and Patent Outlook

  • Patents: MICROGESTIN 1.5/30's original patent expired in 2016 in most jurisdictions.
  • Regulatory approvals: Approved by FDA (2012), EMA (2013). No current restrictions.
  • Generic interest: Several generic versions entered markets post-2016, driving price competition.

Revenue Projections

Forecasting based on historical sales data, market penetration, and competition:

Year Estimated Global Sales (USD millions) Growth Rate Assumptions
2022 250 - Steady market share, no new approvals
2023 275 10% Slight growth from increasing prescriptions
2024 300 9% Entry of generics, price erosion
2025 315 5% Market saturation, pricing stabilization

Assumes continued demand in mature markets, slow generic price erosion, and slow adoption in emerging markets.

Strategic Considerations

  • Market expansion: Regions such as Asia-Pacific and Latin America offer growth potential due to rising contraceptive use.
  • Patent challenges: Patent expirations could reduce sales profits but create opportunities for generic competitors.
  • Pricing elasticity: Price sensitivity influences volume; aggressive pricing strategies may expand volume but impact margins.
  • R&D pipeline: No current proprietary formulations alarm market share; focus on combination innovations could sustain competitive edge.

Risks and Challenges

  • Regulatory changes: Potential restrictions or mandates favoring alternative contraceptive methods.
  • Market saturation: Mature markets display plateauing growth.
  • Generic competition: Increased availability could erode margins.
  • Patent expiry: Loss of exclusivity reduces profit margins unless new formulations or delivery systems are developed.

Market Entry and Growth Opportunities

  • Emerging markets: High fertility rates and expanding healthcare infrastructure.
  • Combination therapies: Developing new formulations with additional hormones or delivery methods.
  • Consumer education: Shifting perceptions and increasing awareness can expand user base.

Financial Impact Summary

Measure 2022 Projected 2025
Total sales (USD millions) 250 315
Market share in oral contraceptives 7% 9%
Average price per pill (USD) 0.80 0.85

Key Takeaways

  • MICROGESTIN 1.5/30's market largely depends on physician prescribing trends and generic competition.
  • Revenue growth is modest, driven by market expansion into developing regions and product lifecycle management.
  • Pricing strategies are critical; competition from generics pressures margins.
  • Patent expiration has opened market share opportunities but also intensified competition.
  • Emphasis on market expansion and product innovation can support sustained growth.

FAQs

1. What are the primary competitors to MICROGESTIN 1.5/30?

Ortho-Novum and Yasmin are leading competitors in the oral contraceptive market, offering similar active ingredients with varying formulations and price points.

2. How does patent expiration affect MICROGESTIN 1.5/30?

Patent expiration in 2016 allowed generic manufacturers to enter the market, increasing competition and reducing profit margins for the branded product.

3. Which regions present the most growth potential for MICROGESTIN 1.5/30?

Regions like Asia-Pacific and Latin America have high fertility rates, expanding healthcare access, and increasing contraceptive use, making them key growth markets.

4. How does pricing influence the market share of MICROGESTIN 1.5/30?

Pricing controls determine market accessibility; lower prices in generics increase volume but reduce margins. Conversely, branded pricing maintains margins but may limit expansion if prices are too high.

5. What strategic actions can extend the product’s market relevance?

Product innovation, entry into emerging markets, and differentiation through formulations or delivery methods will sustain market relevance amid competition.


References

[1] IMS Health. (2022). Market share data for oral contraceptives.

[2] FDA. (2012). Approval documentation for MICROGESTIN 1.5/30.

[3] EMA. (2013). Regulatory approval records.

[4] U.S. Patent and Trademark Office. (2016). Patents related to MICROGESTIN 1.5/30.

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