TWYNSTA Drug Patent Profile

When do Twynsta patents expire, and when can generic versions of Twynsta launch?

Twynsta is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in TWYNSTA is amlodipine besylate; telmisartan. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.

Summary for TWYNSTA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	7
Patent Applications:	2
Drug Prices:	Drug price information for TWYNSTA
What excipients (inactive ingredients) are in TWYNSTA?	TWYNSTA excipients list
DailyMed Link:	TWYNSTA at DailyMed

See drug prices for TWYNSTA

Recent Clinical Trials for TWYNSTA

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

Sponsor	Phase
Hanlim Pharm. Co., Ltd.	Phase 1
Addpharma Inc.	Phase 3
Research Institute for Complex Problems of Cardiovascular Diseases, Russia	Phase 4

See all TWYNSTA clinical trials

US Patents and Regulatory Information for TWYNSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-001	Oct 16, 2009		DISCN	Yes	No
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009		DISCN	Yes	No
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-003	Oct 16, 2009		DISCN	Yes	No
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	Oct 16, 2009		DISCN	Yes	No

Expired US Patents for TWYNSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-001	Oct 16, 2009
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-003	Oct 16, 2009
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	Oct 16, 2009

International Patents for TWYNSTA

See the table below for patents covering TWYNSTA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	4224133
Russian Federation	2124007	BENZIMIDAZOLE DERIVATIVES, THEIR SALTS OR HYDRATES AND PHARMACEUTICAL COMPOSITION SHOWING ANTAGONISTIC ACTIVITY WITH RESPECT TO ANGIOTENSIN-II BASED ON THEREOF
Hungary	T63626
Japan	H06179659	BENZIMIDAZOLES, MEDICINAL COMPOSITIONS CONTAINING THESE COMPOUNDS AND THEIR PREPARATION
Norway	932636
Germany	4212250

Supplementary Protection Certificates for TWYNSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0502314	24/2002	Austria		PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/02/213/001- EU/1/02/213/010 20020419
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705

TWYNSTA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for TWYNSTA

Introduction to TWYNSTA

TWYNSTA is a fixed-dose combination medication that includes telmisartan, an angiotensin II receptor antagonist, and amlodipine, a dihydropyridine calcium channel blocker. It is primarily used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions[1].

Market Size and Growth

The global market for telmisartan, a key component of TWYNSTA, is significant and growing. As of 2023, the global telmisartan market was valued at USD 3,567.30 million and is expected to reach USD 4,661.27 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.4% during the forecast period (2024-2032)[3].

Key Market Drivers

Several factors are driving the growth of the telmisartan market, which in turn influences the demand for TWYNSTA:

Increasing Senior Population

The rise in the senior population is a significant driver, as older adults are more likely to develop hypertension and require antihypertensive medications[3].

Sedentary Lifestyle

A sedentary lifestyle, common in many parts of the world, contributes to the increasing incidence of hypertension, thereby driving the demand for telmisartan and TWYNSTA[3].

Approval of Generic Versions

The approval of abbreviated new drug applications (ANDAs) for generic telmisartan tablets is expected to increase market competition and accessibility, further driving market growth[3].

Chronic Renal Disease

An increase in the incidence of chronic renal disease, which often requires antihypertensive treatment, also contributes to the market expansion[3].

Regional Market Dynamics

North America

North America is expected to be the highest shareholder in the telmisartan market during the forecast period, growing at a CAGR of 3.4%. This dominance is attributed to the high prevalence of hypertension, advanced healthcare facilities, and a well-developed network of hospital and online pharmacies. According to the Centers for Disease Control and Prevention, 75 million persons in the United States have high blood pressure, which significantly drives the demand for telmisartan and TWYNSTA[3].

Asia Pacific

The Asia Pacific region is expected to grow at a higher CAGR of 5.5% during the forecast period. Countries like China and India, with large and densely populated areas, contribute to a significant patient base. Increased healthcare expenditures and rising awareness about the use of telmisartan medications in this region also fuel market growth[3].

Financial Performance of Boehringer Ingelheim

Boehringer Ingelheim, the manufacturer of TWYNSTA, has shown robust financial performance in recent years. Here are some key financial highlights:

Net Sales

In 2020, Boehringer Ingelheim reported net sales of EUR 19,566 million, a 3% increase from the previous year. The Human Pharma segment, which includes TWYNSTA, accounted for 74% of the total net sales[5].

Regional Sales

The Americas and Europe regions each accounted for 45% and 30% of the net sales, respectively, while the Asia/Australia/Africa region contributed 25%[5].

Research and Development

The company invested significantly in research and development, with expenses amounting to EUR 3,696 million in 2020, which is 18.9% of the net sales. This investment is crucial for maintaining and expanding the market presence of drugs like TWYNSTA[5].

Clinical and Economic Benefits

Efficacy

Clinical trials have demonstrated the efficacy of TWYNSTA in achieving significant reductions in both systolic and diastolic blood pressure. For instance, patients with a baseline blood pressure of 160/110 mmHg have a higher likelihood of achieving blood pressure goals with TWYNSTA compared to monotherapy with either telmisartan or amlodipine[1][4].

Cost-Effectiveness

The combination therapy offered by TWYNSTA can be more cost-effective than using separate medications. This is because it simplifies the treatment regimen and potentially reduces the overall cost of managing hypertension.

Challenges and Opportunities

Medication Shortages

Despite the growing demand, medication shortages are expected to hinder the market expansion of telmisartan and, by extension, TWYNSTA. This highlights the need for robust supply chain management and strategic planning to ensure consistent availability[3].

Emerging Markets

There is a significant opportunity for growth in emerging nations, particularly in the Asia Pacific region. An increase in telmisartan-related research and the expansion of healthcare infrastructure in these regions are anticipated to create attractive prospects for market leaders[3].

Conclusion

The market dynamics for TWYNSTA are driven by a combination of demographic, lifestyle, and healthcare-related factors. The growing senior population, sedentary lifestyle, and increasing incidence of chronic renal disease all contribute to the rising demand for telmisartan and TWYNSTA. Boehringer Ingelheim's strong financial performance and significant investments in research and development further support the market trajectory of this drug.

Key Takeaways

• The global telmisartan market is expected to grow at a CAGR of 3.4% from 2024 to 2032.
• North America and the Asia Pacific region are key markets for TWYNSTA.
• The combination therapy of TWYNSTA offers significant clinical and economic benefits.
• Medication shortages and emerging market opportunities are critical factors influencing the market trajectory.
• Boehringer Ingelheim's financial performance and R&D investments support the growth of TWYNSTA.

FAQs

Q: What is TWYNSTA used for?

TWYNSTA is used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events.

Q: What are the components of TWYNSTA?

TWYNSTA is a fixed-dose combination of telmisartan, an angiotensin II receptor antagonist, and amlodipine, a dihydropyridine calcium channel blocker.

Q: What is the expected growth rate of the telmisartan market?

The global telmisartan market is expected to grow at a CAGR of 3.4% from 2024 to 2032.

Q: Which regions are the largest markets for TWYNSTA?

North America and the Asia Pacific region are the largest markets for TWYNSTA.

Q: What are the main drivers of the telmisartan market?

The main drivers include the increasing senior population, sedentary lifestyle, approval of generic versions, and the increasing incidence of chronic renal disease.

Sources

1. RxList: Twynsta (Telmisartan Amlodipine Tablets): Side Effects, Uses ...
2. Annual Reports: Boehringer Ingelheim 2019 Annual Report
3. Straits Research: Telmisartan Market Size, Share and Forecast to 2030
4. FDA: STATISTICAL REVIEW(S) - TWYNSTA® (telmisartan/amlodipine) Tablets
5. Annual Reports: Boehringer Ingelheim 2020 Annual Report