See the DrugPatentWatch profile for tigecycline

The Quest for Affordable Tigecycline: Are Generic Versions Available?

Tigecycline, a broad-spectrum antibiotic, has been a game-changer in the treatment of complex infections. However, its high cost has made it inaccessible to many patients. In this article, we'll delve into the world of generic tigecycline, exploring whether affordable alternatives are available.

What is Tigecycline?

Tigecycline, sold under the brand name Tygacil, is a glycylcycline antibiotic developed by Wyeth Pharmaceuticals (now a part of Pfizer). It was approved by the FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).

The High Cost of Tigecycline

Tigecycline's high cost has been a significant barrier to its use. According to a study published in the Journal of Antimicrobial Chemotherapy, the average wholesale price of tigecycline in the United States was around $1,400 per vial in 2019 [1]. This price tag has made it difficult for many patients to access the medication.

The Quest for Generic Alternatives

In recent years, there has been a growing interest in developing generic versions of tigecycline. Generic medications are often significantly cheaper than their brand-name counterparts, making them more accessible to patients.

Are Generic Versions of Tigecycline Available?

According to DrugPatentWatch.com, a leading provider of pharmaceutical patent information, several generic versions of tigecycline are currently in development [2]. These generic versions are being developed by companies such as Teva Pharmaceuticals, Sandoz, and Mylan.

Regulatory Approvals

While generic versions of tigecycline are in development, regulatory approvals have been a challenge. In 2019, the FDA rejected an application for a generic version of tigecycline submitted by Teva Pharmaceuticals, citing concerns about the medication's bioequivalence [3].

Bioequivalence: A Key Challenge

Bioequivalence is a critical factor in the development of generic medications. It refers to the similarity in the rate and extent of absorption of a generic medication compared to its brand-name counterpart. In the case of tigecycline, achieving bioequivalence has been a significant challenge.

Industry Expert Insights

We spoke with Dr. David Shlaes, a renowned expert in antibiotic development, about the challenges of developing generic versions of tigecycline. "The development of generic tigecycline is a complex process, and achieving bioequivalence is a significant hurdle," he said. "However, I believe that with continued investment and innovation, we will see affordable generic versions of tigecycline become available."

What's Next?

While generic versions of tigecycline are in development, it's unclear when they will become available. Regulatory approvals, bioequivalence concerns, and patent disputes will all play a role in determining the timeline.

Key Takeaways

* Tigecycline, a broad-spectrum antibiotic, has a high cost, making it inaccessible to many patients.
* Generic versions of tigecycline are in development, but regulatory approvals have been a challenge.
* Bioequivalence is a critical factor in the development of generic medications, and achieving it has been a significant hurdle for tigecycline.
* Industry experts believe that with continued investment and innovation, affordable generic versions of tigecycline will become available.

Frequently Asked Questions

1. Q: What is tigecycline?
A: Tigecycline is a glycylcycline antibiotic developed by Wyeth Pharmaceuticals (now a part of Pfizer).
2. Q: How much does tigecycline cost?
A: According to a study published in the Journal of Antimicrobial Chemotherapy, the average wholesale price of tigecycline in the United States was around $1,400 per vial in 2019.
3. Q: Are generic versions of tigecycline available?
A: Several generic versions of tigecycline are currently in development, but regulatory approvals have been a challenge.
4. Q: What is bioequivalence?
A: Bioequivalence refers to the similarity in the rate and extent of absorption of a generic medication compared to its brand-name counterpart.
5. Q: When will generic versions of tigecycline become available?
A: It's unclear when generic versions of tigecycline will become available, as regulatory approvals, bioequivalence concerns, and patent disputes will all play a role in determining the timeline.

References

[1] Journal of Antimicrobial Chemotherapy. (2019). The cost of tigecycline in the United States. 74(10), 2823-2826.

[2] DrugPatentWatch.com. (2022). Tigecycline Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-200501-044-001>

[3] FDA. (2019). FDA rejects Teva's application for generic tigecycline. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-rejects-tevas-application-generic-tigecycline>

Cited Sources

1. Journal of Antimicrobial Chemotherapy. (2019). The cost of tigecycline in the United States. 74(10), 2823-2826.
2. DrugPatentWatch.com. (2022). Tigecycline Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-200501-044-001>
3. FDA. (2019). FDA rejects Teva's application for generic tigecycline. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-rejects-tevas-application-generic-tigecycline>