OSENI Drug Patent Profile

Which patents cover Oseni, and what generic alternatives are available?

Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and one patent family members in forty-two countries.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Oseni

Oseni was eligible for patent challenges on January 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OSENI

International Patents:	101
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	29
Drug Prices:	Drug price information for OSENI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSENI
What excipients (inactive ingredients) are in OSENI?	OSENI excipients list
DailyMed Link:	OSENI at DailyMed

See drug prices for OSENI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OSENI

NDA:

022426

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OSENI

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

US Patents and Regulatory Information for OSENI

OSENI is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes				Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No			Y	Y

Expired US Patents for OSENI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013

International Patents for OSENI

When does loss-of-exclusivity occur for OSENI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Germany

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OSENI around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1111264
South Africa	9605190
South Korea	20110057274	DIPEPTIDYL PEPTIDASE INHIBITORS

Supplementary Protection Certificates for OSENI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	16/2014	Austria		PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923
1586571	511	Finland
0861666	C00861666/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH

Market Dynamics and Financial Trajectory for OSENI

Introduction

OSENI, a combination antidiabetic medication, has been a significant player in the treatment of type 2 diabetes mellitus since its approval by the FDA in 2013. This article delves into the market dynamics and financial trajectory of OSENI, examining its impact, challenges, and future prospects.

Approval and Indications

OSENI is a fixed-dose combination tablet containing alogliptin and pioglitazone, approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[4][5].

Market Context: Antidiabetic Drugs

The market for antidiabetic drugs has seen substantial growth over the past decade. In Canada, for example, spending on antidiabetic drugs has outpaced the overall drug market, doubling the market share from 4.2% to 7.9% between 2012 and 2021. This growth is driven by new classes of drugs, including DPP-4 inhibitors like alogliptin, a key component of OSENI[3].

Sales Performance

OSENI, as part of the DPP-4 inhibitor class, has benefited from the popularity of these medications due to their ease of use and favorable side effect profile. However, specific sales figures for OSENI are not readily available in the public domain. Instead, we can look at the broader category of DPP-4 inhibitors, which have been among the best-selling type 2 diabetes therapies in recent years[5].

Competitive Landscape

The antidiabetic drug market is highly competitive, with various classes of medications vying for market share. DPP-4 inhibitors like OSENI compete with other classes such as SGLT-2 inhibitors (e.g., empagliflozin and canagliflozin) and GLP-1 receptor agonists (e.g., semaglutide). The market share of DPP-4 inhibitors has remained significant, although it has faced challenges from newer classes of drugs that offer additional benefits such as weight management and cardiovascular protection[3].

Pricing and Cost Impact

The cost of antidiabetic medications, including OSENI, has been a significant factor in the overall drug spending landscape. The median annual treatment cost of new medicines launched in recent years has been high, often exceeding $150,000, which can impact the financial trajectory of drugs like OSENI. However, combination therapies like OSENI can offer cost advantages by providing two active ingredients in a single pill, potentially reducing overall treatment costs[1].

Adverse Reactions and Safety Concerns

OSENI, like other antidiabetic medications, comes with its set of adverse reactions and safety concerns. These include risks such as pancreatitis, edema, fractures, and an increased risk of bladder cancer associated with pioglitazone. These safety concerns can affect prescribing patterns and patient adherence, influencing the financial performance of the drug[2][4].

Regulatory and Market Trends

The pharmaceutical market is heavily influenced by regulatory trends and policy changes. For instance, the Inflation Reduction Act in the U.S. is expected to impact drug pricing and manufacturer net revenues. Additionally, biosimilar introductions and generic competition can significantly alter the market dynamics for branded drugs, although OSENI, being a combination of two branded components, is less likely to face immediate generic competition[1].

Future Prospects

The future prospects for OSENI are tied to several factors, including changes in prescribing guidelines, the introduction of new antidiabetic medications, and shifts in patient preferences. As the market continues to evolve, with a focus on newer classes of drugs offering multiple benefits (e.g., GLP-1 inhibitors for both diabetes and weight management), OSENI will need to maintain its competitive edge through its established safety and efficacy profile.

Impact of New-Generation Antidiabetic Drugs

New-generation antidiabetic drugs, particularly GLP-1 receptor agonists, have surged in popularity due to their additional indications for heart failure and weight management. This trend could impact the market share of DPP-4 inhibitors like OSENI, although the ease of use and lower risk of hypoglycemia associated with DPP-4 inhibitors will likely continue to attract patients and prescribers[3].

Financial Projections

While specific financial projections for OSENI are not available, the broader antidiabetic drug market is expected to continue growing, albeit at a slower pace due to increased competition and pricing pressures. The cost per capita for antidiabetic drugs has increased significantly over the past decade, and this trend is expected to continue, albeit with some moderation due to regulatory and competitive factors[3].

Key Takeaways

• Market Growth: The antidiabetic drug market has seen significant growth, driven by new classes of medications.
• Competitive Landscape: OSENI competes in a highly competitive market with various classes of antidiabetic drugs.
• Safety Concerns: OSENI has several adverse reactions and safety concerns that can impact its use.
• Regulatory Trends: Changes in drug pricing policies and the introduction of biosimilars can affect the financial trajectory of branded drugs.
• Future Prospects: OSENI’s future depends on maintaining its competitive edge in a market shifting towards newer classes of drugs.

FAQs

What is OSENI used for?

OSENI is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What are the components of OSENI?

OSENI is a combination of alogliptin and pioglitazone.

What are the common adverse reactions associated with OSENI?

Common adverse reactions include nasopharyngitis, back pain, upper respiratory tract infections, pancreatitis, edema, and fractures.

How does OSENI compare to other antidiabetic medications?

OSENI is part of the DPP-4 inhibitor class, known for its ease of use and lower risk of hypoglycemia compared to other classes like SGLT-2 inhibitors and GLP-1 receptor agonists.

What are the future prospects for OSENI in the antidiabetic drug market?

OSENI’s future prospects depend on its ability to maintain market share in a competitive landscape dominated by newer classes of antidiabetic drugs offering multiple benefits.

Sources

1. Center for Biosimilars: "Biosimilars Account for 23% Market Share, With Wide Uptake Disparities Across Molecules"
2. Drugs.com: "Oseni: Package Insert / Prescribing Information"
3. Government of Canada: "Market Intelligence Report: Antidiabetic Drugs, 2012-2021"
4. RxList: "Oseni (Alogliptin and Pioglitazone Tablets)"
5. Diatribe: "FDA Approves Takeda's DPP-4 inhibitors Nesina, Kazano, and Oseni"