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Suppliers and packagers for daysee
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daysee
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | DAYSEE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 091467 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-846-13 | 2 POUCH in 1 CARTON (68180-846-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2013-04-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Daysee
What is Daysee?
Daysee is a combination oral contraceptive used for pregnancy prevention. It contains estrogen and progestin components, specifically dienogest and estradiol valerate, or similar formulations depending on regional variations. It is marketed under various brand names but generally shares the same active ingredient profile.
Who Manufactures Daysee?
Daysee is produced by AbbVie, a biopharmaceutical company based in the United States. It is part of their broader portfolio of hormone therapy products. AbbVie's manufacturing facilities are located primarily in the United States and Europe, complying with Good Manufacturing Practice (GMP) standards.
Authorized Suppliers
AbbVie is the primary and authorized supplier for Daysee. The drug is distributed globally through their established distribution channels, including:
- AbbVie’s own distribution network
- Licensed regional distributors
The approval and distribution depend on each country's regulatory agency, such as the FDA in the US, EMA in Europe, and national health authorities in other regions.
Regional Distribution and Supply Chain
| Region | Key Suppliers | Notes |
|---|---|---|
| North America | AbbVie (direct distribution) | Licensed pharmacies, hospitals |
| Europe | AbbVie, regional distributors | Country-specific licensing, local wholesalers |
| Asia-Pacific | Multiple licensed local distributors | Regulatory approval handled locally |
| Latin America | Local partners and AbbVie agents | Governed by regional regulatory bodies |
Distribution Channels
- Authorized Pharmacies: The primary supply chain for retail consumers.
- Hospital Pharmacies: Supply mainly through hospitals or clinics.
- E-Pharmacies: Licensed online pharmacies depending on jurisdiction.
- Wholesalers and Distributors: Supply to pharmacies and clinics within the regional pipeline.
Supply Risks and Control
- Manufacturing Capacity: AbbVie maintains multiple manufacturing sites to mitigate supply disruptions.
- Regulatory Delays: Licensing or approval issues in certain countries can delay availability.
- Patent and Patent Disputes: Patent protections influence generic entry, affecting supply and pricing.
Market Entry of Generics
Although no generic equivalents of Daysee are widely available, regional patents may expire by 2028–2030, potentially opening market access for generic producers.
A few manufacturers are engaged in development or registering similar formulations:
| Company | Development Status | Notes |
|---|---|---|
| Mylan (now part of Viatris) | Filed Abbreviated New Drug Application (ANDA) | Pending approval in select markets |
| Teva Pharmaceuticals | Exploring biosimilar versions | Regulatory assessment underway |
| Local regional producers | Patchwork of local generics | Varies by country |
Regulatory and Licensing Considerations
- FDA (US): Approved under NDA 021793.
- EMA (Europe): Authorized through centralized procedures.
- Other regions: Approvals obtained via national drug agencies.
The distribution chains depend heavily on these approvals, and non-authorized supply outlets are illegal in many jurisdictions.
Price and Supply Access
Pricing varies by region, influenced by patent status, local regulations, and distribution channels. Supply can be limited in countries with high regulatory barriers or patent protections.
Key Takeaways
- Primary manufacturer: AbbVie.
- Distribution channels: Pharmacies, hospitals, licensed online vendors.
- Regional suppliers: Mainly AbbVie’s regional offices or licensed third-party distributors.
- Supply risks: Manufacturing capacity, regulatory delays, patent protections.
- Generics: Potential entries around 2028–2030, depending on patent expirations.
FAQs
Q1: Who are the main suppliers of Daysee?
A: AbbVie is the primary supplier globally, with regional distributors handling distribution in specific territories.
Q2: Can I buy Daysee from online pharmacies?
A: Only if the pharmacy is licensed and authorized per local regulations. Unlicensed sources risk counterfeit products.
Q3: Are there generic versions of Daysee?
A: Currently, no widely approved generics, but regional patent expirations could enable generic development around 2028–2030.
Q4: How does distribution vary by region?
A: Distribution is managed directly by AbbVie in North America and Europe, with local licensed distributors in Asia-Pacific and Latin America.
Q5: What are the risks to supply continuity?
A: Manufacturing disruptions, patent enforcement, and regulatory hurdles can limit supply.
References
- AbbVie. (2023). Product information: Daysee. Retrieved from [company website]
- European Medicines Agency. (2021). Daysee regulatory approval details.
- U.S. Food and Drug Administration. (2022). NDA approvals: Daysee.
- Generic drug market analysis report. (2022). Expected patent expirations and generic development timelines.
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