Cardizem LA, a calcium channel blocker containing diltiazem hydrochloride, is utilized for managing hypertension and angina. The drug’s supply chain involves brand-name manufacturers, generic producers, and active pharmaceutical ingredient (API) suppliers. Below is an exhaustive analysis of the suppliers associated with Cardizem LA.
Brand-Name Manufacturer: Bausch Health Companies Inc.
Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals) holds the original FDA approval for Cardizem LA, which was granted on February 6, 2003[1][3]. The brand-name product is available in six strengths (120 mg, 180 mg, 240 mg, 300 mg, 360 mg, and 420 mg) as extended-release tablets[1][8]. Bausch Health’s formulation serves as the Reference Listed Drug (RLD), against which generic versions are bioequivalency-tested[1][7].
Manufacturing and Packaging Details
Cardizem LA tablets are capsule-shaped, film-coated, and debossed with “B” on one side and the dosage strength on the other[8]. They are distributed in 30- and 90-count bottles, with storage recommendations specifying controlled room temperature (15°–30°C) to maintain stability[8].
Generic Manufacturers
Following the expiration of Bausch Health’s patents in 2013 and 2021[3], multiple manufacturers have received FDA approval to produce generic diltiazem hydrochloride extended-release tablets. These suppliers include:
1. Actavis Labs FL Inc.
Approved on March 15, 2010, Actavis (now part of Teva Pharmaceuticals) offers generic Cardizem LA in all six strengths[1]. The company is a major player in the generic market, with a history of filing Paragraph IV certifications to challenge patents[3].
2. AMTA
AMTA secured FDA approval for its generic version on March 7, 2023, covering all dosage forms[1]. This newer entrant contributes to increased market competition and affordability.
3. SCIEGEN PHARMS INC.
Approved on April 6, 2023, SciGen Pharmaceuticals further expands the generic supply chain, ensuring widespread availability of cost-effective alternatives[1].
Pricing and Market Availability
Generic versions are priced significantly lower than the brand-name product. For example, a 30-tablet supply of 120 mg generic diltiazem costs approximately $68.39, compared to $128.39 for the brand[4]. Larger quantities (e.g., 90 tablets) yield additional savings, with generics often priced 40–50% below Cardizem LA[4].
Active Pharmaceutical Ingredient (API) Suppliers
Diltiazem hydrochloride, the API in Cardizem LA, is sourced from specialized manufacturers globally. Key suppliers include:
1. LGM Pharma
A leader in API sourcing, LGM Pharma provides high-quality diltiazem hydrochloride for generic formulations[6].
2. Fermion Oy
This Finnish company supplies APIs for cardiovascular drugs, adhering to stringent EU and FDA standards[6].
3. Divis Laboratories
An India-based manufacturer, Divis Laboratories produces diltiazem hydrochloride compliant with global pharmacopeias[6].
4. Zim Laboratories
Known for modified-release technologies, Zim supports pelletized formulations used in extended-release tablets[6].
Distribution and Pharmacy Networks
Cardizem LA and its generics are distributed through major pharmaceutical wholesalers, including:
- Cardinal Health
- McKesson
- AmerisourceBergen[9][10]
These distributors ensure that both brand and generic products reach retail pharmacies, hospitals, and online platforms. Patients can access the medication via reputable pharmacies such as Canada Drugs Direct, which offers international shipping for the brand-name product[2][5].
Regulatory and Patent Considerations
Patent Expiry and Generic Entry
Cardizem LA’s key patents, including:
- US6923984 (expired February 2021)
- US7108866 (expired December 2019)
- US5529791 (expired June 2013)[3]
facilitated generic entry starting in 2010. The first generic approval to Actavis Labs FL Inc. leveraged a Paragraph IV certification, disputing the validity of remaining patents[3].
Bioequivalence Standards
Generics must demonstrate therapeutic equivalence to the RLD, coded as AB by the FDA. Products with the AB designation meet rigorous bioequivalence criteria, ensuring interchangeability with Cardizem LA[1][7].
Challenges in the Supply Chain
Counterfeit Products
Fraudulent online pharmacies occasionally sell illegal generic versions, which may be substandard or counterfeit[1][5]. Regulatory agencies emphasize purchasing from verified distributors to mitigate this risk.
Market Fragmentation
With over 37 companies filing for generic diltiazem hydrochloride[3], the market is highly fragmented. This competition drives price reductions but necessitates stringent quality control to maintain efficacy and safety.
Conclusion
Cardizem LA’s supply chain is anchored by Bausch Health’s brand-name product and supplemented by generic manufacturers such as Actavis, AMTA, and SciGen. API suppliers like LGM Pharma and Divis Laboratories ensure a steady raw material supply, while distributors like McKesson bridge the gap between manufacturers and end-users. The expiration of critical patents has democratized market access, though vigilance against counterfeit products remains essential for patient safety.
Key Takeaways
- Brand Supplier: Bausch Health Companies Inc.
- Generic Suppliers: Actavis Labs FL Inc., AMTA, SciGen Pharms Inc.
- API Manufacturers: LGM Pharma, Fermion Oy, Divis Laboratories.
- Distributors: Cardinal Health, McKesson, AmerisourceBergen.
- Regulatory Status: Generics are bioequivalent (AB-rated) and widely available post-2021 patent expirations.
FAQs
-
Is there a generic version of Cardizem LA?
Yes, multiple FDA-approved generics are available from Actavis, AMTA, and SciGen[1][3].
-
Who manufactures the active ingredient in Cardizem LA?
Companies like LGM Pharma and Divis Laboratories supply diltiazem hydrochloride[6].
-
What is the price difference between brand and generic Cardizem LA?
Generics cost 40–50% less; e.g., 120 mg generic tablets are $68.39 vs. $128.39 for the brand[4].
-
Are Cardizem LA generics safe?
Yes, FDA-approved generics meet strict bioequivalence standards[1][7].
-
Can I purchase Cardizem LA internationally?
Yes, Canadian pharmacies like Canada Drugs Direct offer the brand-name product[2][5].
References
- https://www.drugs.com/availability/generic-cardizem-la.html
- https://www.canadianpharmacyking.com/Drug/Cardizem+LA
- https://pharsight.greyb.com/drug/cardizem-la-patent-expiration
- https://www.drugs.com/price-guide/cardizem-la
- https://www.canadadrugsdirect.com/products/cardizem-la
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/cardizem-cd
- https://www.drugs.com/availability/generic-cardizem-cd.html
- https://www.empr.com/drug/cardizem-la/
- https://www.slaterunpharma.com/products/diltiazem-hydrochloride-capsules/
- https://www.slaterunpharma.com/products/diltiazem-hydrochloride-tablets/
