PRAMLINTIDE ACETATE - Generic Drug Details

What are the generic drug sources for pramlintide acetate and what is the scope of patent protection?

Pramlintide acetate is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for pramlintide acetate. One supplier is listed for this compound.

Summary for PRAMLINTIDE ACETATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	21
Patent Applications:	5,795
What excipients (inactive ingredients) are in PRAMLINTIDE ACETATE?	PRAMLINTIDE ACETATE excipients list
DailyMed Link:	PRAMLINTIDE ACETATE at DailyMed

Recent Clinical Trials for PRAMLINTIDE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	N/A
Juvenile Diabetes Research Foundation	N/A
McGill University	N/A

See all PRAMLINTIDE ACETATE clinical trials

Pharmacology for PRAMLINTIDE ACETATE

Drug Class	Amylin Analog
Mechanism of Action	Amylin Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PRAMLINTIDE ACETATE

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for PRAMLINTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007		RX	Yes	No
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005		DISCN	No	No
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007		RX	Yes	Yes

Expired US Patents for PRAMLINTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005

PRAMLINTIDE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pramlintide Acetate

Introduction to Pramlintide Acetate

Pramlintide acetate, a synthetic analogue of the human hormone amylin, was approved in March 2005 for the adjunctive treatment of type 1 and type 2 diabetes mellitus. It is marketed under the brand name Symlin and is used to improve glycemic control in patients who have not achieved optimal results with insulin therapy alone[5].

Market Context and Acquisition

The Amylin Acquisition

A significant event in the market dynamics of pramlintide acetate was the acquisition of Amylin Pharmaceuticals, the developer and manufacturer of Symlin, by Bristol-Myers Squibb (BMS) in 2012. This acquisition was part of a joint deal with AstraZeneca, where BMS acquired Amylin for $5.3 billion in cash and assumed $1.7 billion in debt and other obligations. AstraZeneca subsequently paid $3.4 billion to BMS for a 50% share in the profits and losses from Amylin's drugs, including Symlin[2].

Strategic Implications

This acquisition was strategic for both BMS and AstraZeneca, as it expanded their diabetes treatment portfolios. The deal included access to Amylin's other diabetes drugs, such as Byetta and Bydureon, and strengthened their partnership in the diabetes market. This collaboration allowed the companies to leverage their existing marketing capabilities and reduce the risks associated with developing and marketing new diabetes treatments[2].

Financial Performance

Revenue Growth

The acquisition of Amylin and its products, including Symlin, contributed significantly to the financial performance of BMS. In 2012, BMS reported strong double-digit growth in sales of its new and in-line products, with the diabetes franchise being a key driver. The addition of Symlin and other Amylin products helped BMS to mitigate the financial impact of losing exclusivity for its major products, Plavix and Avapro/Avalide[3].

Cost and Revenue Balance

Pramlintide acetate, as part of the broader diabetes treatment portfolio, has been beneficial in managing the total costs associated with diabetes complications. By improving glycemic control, reducing postprandial glucose levels, and managing weight loss, pramlintide can help reduce the long-term healthcare costs associated with uncontrolled diabetes[5].

Market Forecast

Global Market Insights

The global market for pramlintide acetate is expected to grow, driven by increasing prevalence of diabetes and the need for adjunctive therapies to improve glycemic control. Market research reports indicate that the global Symlin market will continue to see growth, with forecasts extending to 2029. These reports provide detailed market data and forecasts, highlighting the potential for continued expansion in the diabetes treatment market[1].

Competitive Landscape

The diabetes treatment market is highly competitive, with several glucagon-like peptide-1 (GLP-1) agonists and other antidiabetic agents available. However, pramlintide acetate's unique mechanism of action, which complements insulin therapy by decreasing glucagon secretion and slowing gastric emptying, positions it as a valuable option in the treatment regimen for diabetes patients[5].

Clinical Efficacy and Adverse Effects

Clinical Benefits

Pramlintide acetate has been shown to suppress postmeal glucagon secretion, reduce postprandial glucose levels, and improve glycemic control. It also helps in managing weight loss and decreasing hemoglobin A(1c), serum fructosamine, and total cholesterol levels. These clinical benefits contribute to its market appeal and financial performance[5].

Adverse Effects and Safety Profile

While pramlintide acetate offers significant clinical benefits, it is associated with adverse effects such as nausea, anorexia, fatigue, and vomiting. Additionally, there is an increased risk of insulin-induced severe hypoglycemia when used in combination with insulin. These factors must be considered in the overall market strategy and patient management[5].

Regulatory and Approval Landscape

Approval History

Pramlintide acetate was approved by the FDA in March 2005 for the treatment of type 1 and type 2 diabetes. This approval marked a significant milestone in the treatment of diabetes, offering a new class of amylinomimetic compounds to patients who had not achieved adequate glycemic control with insulin alone[5].

Ongoing Research and Development

Continuous research and development are crucial in the pharmaceutical industry. While pramlintide acetate is an established product, ongoing studies and clinical trials may explore new indications or dosing regimens, potentially expanding its market reach and financial impact.

Market Penetration and Sales

Sales Performance

The acquisition by BMS and the partnership with AstraZeneca have enhanced the sales performance of pramlintide acetate. The combined marketing efforts and existing distribution channels have helped in increasing the product's market penetration and sales. For instance, BMS reported a significant increase in sales of its diabetes franchise, including Symlin, following the acquisition[3].

Geographical Expansion

The global reach of BMS and AstraZeneca has facilitated the geographical expansion of pramlintide acetate. The product is now available in multiple regions, contributing to its growing market share and revenue.

Future Outlook

Market Growth Potential

The diabetes treatment market is expected to continue growing due to the increasing prevalence of diabetes worldwide. Pramlintide acetate, with its unique mechanism of action and clinical benefits, is well-positioned to capture a significant share of this growing market.

Potential for Further Collaboration

The successful collaboration between BMS and AstraZeneca on the Amylin acquisition and subsequent management of its products suggests potential for further strategic partnerships or acquisitions in the diabetes treatment space. Such collaborations could further enhance the market dynamics and financial trajectory of pramlintide acetate.

Key Takeaways

• Acquisition Impact: The acquisition of Amylin by BMS and the partnership with AstraZeneca significantly enhanced the market position and financial performance of pramlintide acetate.
• Clinical Efficacy: Pramlintide acetate offers unique clinical benefits by complementing insulin therapy and improving glycemic control.
• Market Forecast: The global market for pramlintide acetate is expected to grow, driven by the increasing prevalence of diabetes and the need for adjunctive therapies.
• Regulatory Approval: Approved in 2005, pramlintide acetate has established itself as a valuable treatment option for diabetes patients.
• Future Outlook: The product is well-positioned for continued growth, with potential for further collaborations and geographical expansion.

FAQs

Q: What is pramlintide acetate used for?

A: Pramlintide acetate is used as an adjunctive treatment for patients with type 1 or type 2 diabetes mellitus who have not achieved adequate glycemic control with insulin therapy alone.

Q: Who acquired Amylin Pharmaceuticals, the developer of pramlintide acetate?

A: Bristol-Myers Squibb (BMS) acquired Amylin Pharmaceuticals in 2012, with AstraZeneca participating as a joint partner.

Q: What are the main clinical benefits of pramlintide acetate?

A: Pramlintide acetate suppresses postmeal glucagon secretion, reduces postprandial glucose levels, improves glycemic control, and helps in managing weight loss.

Q: What are the common adverse effects associated with pramlintide acetate?

A: Common adverse effects include nausea, anorexia, fatigue, vomiting, and an increased risk of insulin-induced severe hypoglycemia.

Q: What is the market forecast for pramlintide acetate?

A: The global market for pramlintide acetate is expected to grow, driven by the increasing prevalence of diabetes and the need for adjunctive therapies, with forecasts extending to 2029.

Sources

1. Global Symlin (pramlintide) Market Insights, Forecast to 2029. Market Research Report Summary. Published on August 15, 2023.
2. BMS to Acquire Amylin for USD5.3 Bil., Expanding AstraZeneca. S&P Global Market Intelligence.
3. 2012 Annual Report - Bristol Myers Squibb. BMS.
4. Pramlintide acetate | Anti-diabetic Agent | MedChemExpress.
5. Pramlintide acetate - PubMed. Published in 2005.