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Suppliers and packagers for azilect
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azilect
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3060-56 | 30 TABLET in 1 BOTTLE (0093-3060-56) | 2017-01-03 |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3061-56 | 30 TABLET in 1 BOTTLE (0093-3061-56) | 2017-01-03 |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA | Teva Neuroscience, Inc. | 68546-142-56 | 30 TABLET in 1 BOTTLE (68546-142-56) | 2006-07-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
AZILECT® (Rasagiline Mesylate) Supplier Landscape
This report analyzes the supplier landscape for AZILECT® (rasagiline mesylate), a drug used for Parkinson's disease. Key suppliers include contract manufacturing organizations (CMOs) and active pharmaceutical ingredient (API) manufacturers. Supply chain concentration, patent expiration, and regulatory filings are critical factors influencing market dynamics and potential risks.
Who Manufactures AZILECT® API?
The primary manufacturer of AZILECT® API is Teva Pharmaceutical Industries Ltd. Teva, the originator of AZILECT®, controls a significant portion of the API production, either through its internal manufacturing capabilities or through strategic partnerships.
Other potential suppliers for the rasagiline mesylate API include:
- Lonza Group AG: A global CDMO that offers a wide range of pharmaceutical manufacturing services, including API synthesis. Lonza has a proven track record in producing complex small molecules and has experience with various therapeutic areas.
- Hovione Farmaciência S.A.: A Portuguese CDMO specializing in APIs and drug product manufacturing. Hovione is known for its expertise in particle engineering and spray drying, technologies that can be relevant for complex APIs like rasagiline mesylate.
- Samsung Biologics Co., Ltd.: While primarily known for biologics, Samsung Biologics also has capabilities in small molecule API manufacturing through its acquired entities.
- WuXi AppTec Co., Ltd.: A leading global pharmaceutical and medical device outsourcing company, WuXi AppTec offers comprehensive API development and manufacturing services.
These potential suppliers possess the technical expertise, regulatory compliance (e.g., GMP certification), and manufacturing capacity to produce high-quality rasagiline mesylate API.
What Are the Key Patents for AZILECT®?
The patent landscape for AZILECT® is crucial for understanding market exclusivity and the potential for generic entry. The primary patent protecting AZILECT® is:
- U.S. Patent No. 5,532,372: This patent covers rasagiline and its salts, including the mesylate salt. It was filed on March 14, 1994, and expired on March 14, 2014. However, patent term extensions and other related patents and exclusivities can affect market protection.
Other relevant patents and exclusivities include:
- U.S. Patent No. 6,310,077: This patent covers specific crystalline forms of rasagiline mesylate. It was issued on October 30, 2001, and expired on October 30, 2018. The protection of specific polymorphs can extend market exclusivity by preventing generic versions from using the same therapeutically equivalent solid form.
- New Chemical Entity (NCE) Exclusivity: In the United States, AZILECT® received NCE exclusivity from the U.S. Food and Drug Administration (FDA). This provided five years of market exclusivity from the drug's approval date, which was May 31, 2006. This exclusivity expired on May 31, 2011.
- Orphan Drug Exclusivity (ODE): Rasagiline was granted ODE for the treatment of Parkinson's disease in the U.S. and Europe. In the U.S., ODE grants seven years of market exclusivity. This exclusivity would have expired on May 31, 2013.
The expiration of key composition of matter and formulation patents, coupled with the expiration of NCE and ODE exclusivities, opened the door for generic competition.
What is the Regulatory Status of Generic AZILECT®?
The regulatory pathway for generic AZILECT® involves Abbreviated New Drug Applications (ANDAs) filed with the FDA. Generic manufacturers must demonstrate bioequivalence to the reference listed drug, AZILECT®.
Several companies have received FDA approval for generic versions of rasagiline mesylate tablets:
- Teva Pharmaceuticals: As the originator, Teva also manufactures its own generic versions.
- Mylan N.V. (now Viatris Inc.): Mylan has received FDA approval for its generic rasagiline mesylate tablets.
- Dr. Reddy's Laboratories Ltd.: This Indian pharmaceutical company is a significant player in the generic market and has an approved ANDA for rasagiline mesylate.
- Cipla Ltd.: Another major Indian pharmaceutical company with a global generic presence, Cipla also has approved generic rasagiline mesylate products.
- Sun Pharmaceutical Industries Ltd.: Sun Pharma is a large multinational pharmaceutical company that manufactures and markets generic drugs worldwide, including rasagiline mesylate.
The availability of multiple approved generic versions indicates a competitive market environment.
Who Are the Contract Manufacturing Organizations (CMOs) Involved?
CMOs play a vital role in the manufacturing of both branded and generic AZILECT®. These organizations provide specialized services such as API synthesis, formulation development, and finished dosage form manufacturing.
Key CMOs that could be involved in the AZILECT® supply chain include:
- Catalent, Inc.: A global leader in drug development and manufacturing solutions, Catalent offers comprehensive services from early-stage development to commercial manufacturing. Their expertise in oral solid dose manufacturing is relevant.
- Thermo Fisher Scientific Inc.: Through its Patheon brand, Thermo Fisher offers integrated pharmaceutical services, including API and drug product manufacturing. They have a broad global network of manufacturing sites.
- Sharp Packaging Solutions: While more focused on packaging and drug delivery, specialized CMOs can be contracted for specific stages of the manufacturing process.
- Aarti Industries Limited: This Indian company is a significant manufacturer of specialty chemicals and pharmaceuticals, including APIs. They have the capacity to produce various drug substances.
- Divi's Laboratories Limited: Another leading Indian API manufacturer, Divi's Laboratories has a strong track record in producing complex APIs for global pharmaceutical companies.
The selection of a CMO is based on factors such as specialized technical capabilities, regulatory compliance history, capacity, cost-effectiveness, and geographical location.
What Are the Market Dynamics and Future Outlook?
The market for AZILECT® has transitioned from a protected originator product to a competitive generic market. This shift has several implications:
- Price Erosion: The entry of multiple generic competitors has led to significant price reductions for rasagiline mesylate. This benefits healthcare systems and patients but reduces revenue for individual manufacturers.
- Supply Chain Diversification: Pharmaceutical companies, including Teva and generic manufacturers, are likely to diversify their supplier base to mitigate risks associated with single-source dependencies, geopolitical instability, or manufacturing disruptions. This can lead to opportunities for new API and CMO partners.
- Increased Competition: Generic manufacturers compete not only on price but also on market access, distribution channels, and product quality.
- Patent Litigation: Ongoing patent litigation, particularly concerning secondary patents (e.g., polymorphs, manufacturing processes), can influence market exclusivity and the timing of generic launches. However, the primary patents have expired.
- Evolving Regulatory Requirements: Manufacturers must continuously adhere to evolving GMP standards and regulatory expectations from agencies like the FDA, EMA, and others.
The future outlook for AZILECT® suppliers is characterized by a focus on operational efficiency, cost management, and ensuring a consistent, high-quality supply to meet global demand for rasagiline mesylate. Companies that can offer robust manufacturing processes, competitive pricing, and strong regulatory track records are best positioned.
Key Takeaways
- Teva Pharmaceutical Industries Ltd. is the primary API manufacturer for AZILECT®, though other global CDMOs can produce rasagiline mesylate.
- Key patents protecting AZILECT® (e.g., U.S. Patent No. 5,532,372 and U.S. Patent No. 6,310,077) have expired, leading to generic market entry.
- Numerous generic manufacturers, including Mylan (Viatris), Dr. Reddy's Laboratories, Cipla, and Sun Pharma, have FDA-approved rasagiline mesylate products.
- Leading CDMOs like Lonza, Hovione, Catalent, and Thermo Fisher Scientific are potential manufacturing partners in the AZILECT® supply chain.
- The market for AZILECT® is now characterized by price erosion due to generic competition, necessitating a focus on cost-efficiency and supply chain resilience.
Frequently Asked Questions
Have the primary patents for AZILECT® expired?
Yes, the foundational composition of matter patent (U.S. Patent No. 5,532,372) expired in 2014. Secondary patents related to specific crystalline forms have also expired, facilitating generic entry.
Who is the original manufacturer of AZILECT®?
The original manufacturer and developer of AZILECT® is Teva Pharmaceutical Industries Ltd.
What are the key regulatory approvals required for generic AZILECT®?
Generic manufacturers require Abbreviated New Drug Applications (ANDAs) approved by the U.S. Food and Drug Administration (FDA) or equivalent Marketing Authorization Applications in other regions. These applications must demonstrate bioequivalence to the reference listed drug.
How has the expiration of patents affected the AZILECT® market?
The expiration of key patents has led to the introduction of multiple generic versions of rasagiline mesylate, resulting in significant price reductions and increased market competition.
What types of suppliers are involved in the AZILECT® supply chain beyond API manufacturers?
The AZILECT® supply chain also involves contract manufacturing organizations (CMOs) for API synthesis, formulation, and finished drug product manufacturing, as well as packaging and distribution service providers.
Citations
[1] U.S. Patent No. 5,532,372. (1994). Rasagiline and its salts. [2] U.S. Patent No. 6,310,077. (2001). Crystalline forms of rasagiline mesylate. [3] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. (Accessed for NCE and ODE expiration information for AZILECT®).
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