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Suppliers and packagers for generic pharmaceutical drug: SARECYCLINE HYDROCHLORIDE
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SARECYCLINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521 | NDA | Almirall, LLC | 16110-245-30 | 30 TABLET, COATED in 1 BOTTLE (16110-245-30) | 2019-01-04 |
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521 | NDA | Almirall, LLC | 16110-246-30 | 30 TABLET, COATED in 1 BOTTLE (16110-246-30) | 2019-01-04 |
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521 | NDA | Almirall, LLC | 16110-247-30 | 30 TABLET, COATED in 1 BOTTLE (16110-247-30) | 2019-01-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SARECYCLINE HYDROCHLORIDE
Introduction
Sarecycline hydrochloride is a second-generation tetracycline antibiotic primarily used for treating moderate to severe acne vulgaris in patients aged 9 and older. Its precise mechanism involves inhibiting bacterial protein synthesis, leading to bacteriostatic effects. As a relatively recent addition to the antibiotic arsenal, the sourcing and supply chain of sarecycline hydrochloride are critical components influencing its availability, price stability, and market penetration. This article explores the primary suppliers of sarecycline hydrochloride, examining their production capacities, geographic footprints, and strategic significance within the pharmaceutical supply network.
Manufacturers of Sarecycline Hydrochloride
1. Allergan (AbbVie Inc.)
Overview:
Allergan, acquired by AbbVie in 2020, is the original developer and patent holder of sarecycline hydrochloride. AbbVie’s pharmaceutical division maintains the exclusive rights to manufacture and market sarecycline globally. As a pioneering entity, AbbVie's manufacturing facilities are strategically situated to meet global demand.
Supply Capabilities:
AbbVie has invested significantly in establishing high-purity synthesis processes and scalable manufacturing lines. Their facilities in the United States and Ireland are certified by major regulatory bodies (FDA, EMA), ensuring compliance with Good Manufacturing Practices (GMP). Currently, AbbVie is the primary supplier worldwide, controlling the entire supply chain for sarecycline hydrochloride.
Market Control:
AbbVie's exclusivity positions it as the dominant supplier, with licensing arrangements limited to geographic-specific distributors in some markets. Its robust manufacturing infrastructure gives it an advantage over potential generic competitors, securing supply stability for the foreseeable future.
2. Contract Manufacturing Organizations (CMOs)
While AbbVie is the principal producer, several Contract Manufacturing Organizations are licensed or contracted to supply sarecycline hydrochloride in various regions under strict quality agreements. These include:
-
Lannett Company Inc.:
Known for producing generic pharmaceuticals, Lannett has expressed interest in developing generic versions of sarecycline. However, their current involvement appears limited due to patent restrictions. -
Piramal Pharma Solutions:
A leading CMO, Piramal offers custom synthesis and formulation services. Although not confirmed as a sarecycline hydrochloride producer, their expertise positions them as potential future suppliers upon patent expiry or licensing arrangements. -
Catalent Inc.:
Catalent provides advanced manufacturing and formulation services for antibiotics; however, specific issuance for sarecycline remains unconfirmed as of now.
Note:
Most generics remain under development or are hindered by patent protections held by AbbVie, which limit external manufacturing licensing until patent expiration or settlement.
Emerging and Potential Suppliers
1. Generics Manufacturers
The patent for sarecycline hydrochloride is expected to expire in the mid-2020s, opening opportunities for generic manufacturers to enter the market.
-
Zydus Cadila:
An Indian pharmaceutical company with a strong track record of developing tetracycline derivatives and antibiotics. They have publicly indicated their intent to develop generic sarecycline formulations. -
Aurobindo Pharma:
Known for producing various antibiotics, Aurobindo is expected to develop a generic sarecycline once patent barriers are lifted, with ongoing research into formulation synthesis. -
Mylan (now part of Viatris):
Has historically been active in developing tetracyclinics; their pipeline may include sarecycline generics post-patent expiry.
2. Chinese and Indian API Suppliers
The Active Pharmaceutical Ingredient (API) manufacturing landscape in India and China provides options for downstream formulation companies.
-
Bulk API Suppliers:
Companies such as Hengkang Pharmaceutical and Shandong Lukang Pharmaceutical have capacity for tetracycline class APIs, including related derivatives. Whether they produce sarecycline-specific API at commercial scale remains to be confirmed but represents a potential supply source for innovator and generic manufacturers. -
Regulatory Challenges:
API imports from these regions require stringent quality assurance (QA) and certification processes, with potential delays due to geopolitical or regulatory factors.
Supply Chain Dynamics and Challenges
-
Patent Protections:
The exclusivity rights held by AbbVie significantly restrict generic entry until patent expiration. Market entrants must navigate legal challenges or wait for patent cliffs. -
Regulatory Approvals:
New suppliers or generics require comprehensive clinical and quality data to attain regulatory approval, influencing lead times and supply reliability. -
Manufacturing Capacity Constraints:
Limited manufacturing capacity in the early post-patent era may lead to supply shortages, especially if demand exceeds initial projections. -
Geopolitical Factors:
Trade tensions and regulatory policies in China, India, and the U.S. can influence sourcing and supply stability.
Conclusion
Supply of sarecycline hydrochloride is predominantly dominated by AbbVie's manufacturing operations, leveraging advanced production capabilities and regulatory compliance to maintain market exclusivity. The emergence of generics is anticipated to reshape the supply landscape post-patent expiry, with Indian and Chinese manufacturers poised to enter the fray pending regulatory clearances and patent challenges.
For stakeholders, securing supply involves monitoring patent landscapes, engaging with authorized distributors, and preparing for increased competition from generic manufacturers. Ensuring quality and regulatory compliance remains paramount, given the antibiotic's critical role in dermatology and potential public health implications.
Key Takeaways
- AbbVie remains the sole primary supplier for sarecycline hydrochloride globally, leveraging proprietary manufacturing and patent protections.
- Generic manufacturers in India and China are preparing for market entry following patent expiration, offering potential alternatives with comparable quality.
- Regulatory approval, patent protections, and manufacturing capacity constraints are critical factors influencing supply stability currently and in the future.
- Contract manufacturing organizations may serve as additional supply sources once licensing and production agreements are established.
- Supply chain resilience depends on proactive monitoring of patent status, regulatory developments, and geopolitical factors affecting manufacturing regions.
FAQs
1. When will generic sarecycline hydrochloride likely become available?
Patent protections in many jurisdictions are expected to expire around the mid-2020s, potentially opening the market for generics from Indian and Chinese manufacturers. Exact timing depends on patent litigation and regulatory approvals.
2. Who are the current manufacturers of sarecycline hydrochloride?
AbbVie (formerly Allergan) is the exclusive manufacturer and patent holder. No widespread generic manufacturing exists presently.
3. What factors could disrupt the supply of sarecycline hydrochloride?
Patent enforcement, manufacturing capacity limits, supply chain disruptions, and geopolitical issues could impact availability.
4. Are there alternative antibiotics with similar efficacy?
Yes. Tetracycline derivatives like doxycycline and minocycline are alternative treatments but differ in spectrum, side effects, and dosing.
5. How does the supply influence drug pricing?
Limited supply and patent exclusivity tend to keep prices high; increased generic competition post-patent expiry could lower costs significantly.
References
- [1] FDA Approval History — Sarecycline.
- [2] AbbVie Corporate Profile and Manufacturing Overview.
- [3] Patent Status and Market Exclusivity Reports — U.S. Patent and Trademark Office.
- [4] GlobalAPI Market Analysis Reports — IQVIA.
- [5] Industry Publications on Antibiotic Generic Manufacturing in India and China.
Disclaimer:
This article provides an overview based on publicly available data up to 2023 and is intended for informational purposes only. Stakeholders should verify current patents, regulatory statuses, and supply agreements before making procurement or investment decisions.
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