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Drugs in ATC Class G03DB
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Drugs in ATC Class: G03DB - Pregnadien derivatives
| Tradename | Generic Name |
|---|---|
| GYNOREST | dydrogesterone |
| MEGACE | megestrol acetate |
| MEGACE ES | megestrol acetate |
| MEGESTROL ACETATE | megestrol acetate |
| NATAZIA | dienogest; estradiol valerate |
| >Tradename | >Generic Name |
G03DB Market Analysis and Financial Projection
Pregnadien derivatives, classified under ATC code G03DB, encompass a group of synthetic progestogens used in gynecological and hormonal therapies. These compounds, including dydrogesterone, megestrol, and dienogest, are primarily prescribed for conditions like endometriosis, menstrual disorders, and hormone replacement therapy. Below is an analysis of their market dynamics and patent landscape.
Market Dynamics
1. Therapeutic Applications
- Gynecological Disorders: Pregnadien derivatives treat corpus luteum insufficiency, dysfunctional uterine bleeding, and endometriosis[1][8].
- Contraception and Hormone Therapy: Some derivatives (e.g., dienogest) are used in hormonal contraceptives and menopausal hormone therapy[7][14].
- Oncology: Megestrol acetate serves as an appetite stimulant in cancer patients and an antineoplastic agent[14].
2. Regional Consumption Trends
- Kosovo (2011–2013): G03DB drugs accounted for 0.30–0.46% of total G-class medicine consumption, reflecting niche but growing use[2].
- Latvia (2013–2017): Pregnadien derivatives constituted 0.79–0.82% of total ATC-classified drug sales, indicating stable demand[6].
3. Safety Considerations
- Hypospadias Risk: A EUROmediCAT study linked prenatal exposure to G03DB drugs with a 1.4x increased risk of hypospadias and congenital heart defects[9].
Patent Landscape
1. Key Patents and Innovations
- Structural Derivatives:
- US2891079A (1959): Covers 6-methyl-4,6-pregnadiene derivatives with reduced adrenal toxicity, emphasizing improved safety profiles[4].
- CA2069932A1 (1993): Describes microbial fermentation methods to produce 20-methyl-5,7-pregnadiene derivatives[10].
2. Recent Filings and Expiries
- Dienogest (NATAZIA): Bayer’s patent (US8071577) for dienogest-containing contraceptives expires in 2026[7]. This may prompt generic competition post-expiry.
3. Jurisdictional Trends
- China leads in GenAI-related patent filings (40,000+ filings from 2014–2023), though most G03DB patents originate from the U.S. and Europe[3][4][10].
Competitive and R&D Insights
- Innovation Focus: Recent patents prioritize enhanced bioavailability and reduced side effects (e.g., adrenal toxicity)[4][10].
- Manufacturing Advances: Methods like bacterial fermentation aim to streamline production[10].
- Market Players: Key developers include Bayer (dienogest), Pfizer (megestrol), and generic manufacturers in Asia[7][8].
Key Takeaways
- Niche Market: G03DB drugs hold a small but stable market share, driven by specialized gynecological and oncological uses.
- Patent Cliffs: Expiring patents (e.g., dienogest in 2026) may increase generic competition, affecting pricing dynamics.
- Safety and Innovation: Balancing efficacy with safety remains critical, as evidenced by regulatory scrutiny over congenital risks[9].
FAQs
-
What are common G03DB drugs?
Dydrogesterone, megestrol, and dienogest are widely prescribed for menstrual disorders and contraception. -
How does dienogest’s patent expiry affect the market?
Generic entries post-2026 could lower costs but reduce Bayer’s market dominance. -
Are pregnadien derivatives safe during pregnancy?
Linked to hypospadias risk; contraindicated in pregnancy without strict medical supervision[9]. -
Which regions lead in G03DB innovation?
The U.S. and Europe hold foundational patents, while China dominates in bulk manufacturing. -
What drives R&D in this class?
Focus on reducing side effects (e.g., adrenal toxicity) and improving production efficiency[4][10].
References
- https://atcddd.fhi.no/atc_ddd_index/?code=G03DB&showdescription=yes
- http://conferences.ubt-uni.net/2018/wp-content/uploads/2018/09/ICMPS.pdf
- https://www.patentnext.com/2024/08/wipo-issues-a-patent-landscape-report-on-generative-artificial-intelligence-genai/
- https://patents.google.com/patent/US2891079A/en
- https://www.wikidoc.org/index.php/ATC_code_G03
- https://www.zva.gov.lv/sites/default/files/2018-05/zva-zstat-2017.pdf
- https://drugcentral.org/drugcard/871
- https://atcddd.fhi.no/atc_ddd_index/?code=G03DB&showdescription=no
- https://pmc.ncbi.nlm.nih.gov/articles/PMC5137835/
- https://patents.google.com/patent/CA2069932A1/en
- https://sagaciousresearch.com/patent-landscape-analysis-search-report/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8076393/
- https://en.wikipedia.org/wiki/Pregnadiene
- https://go.drugbank.com/categories/DBCAT002333
- https://www.kup.at/kup/pdf/10165.pdf
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