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:	1
Clinical Trials:	7
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	022401-003	Oct 16, 2009
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	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	4117121
Denmark	0552765
Hungary	T64955
Japan	H06179659	BENZIMIDAZOLES, MEDICINAL COMPOSITIONS CONTAINING THESE COMPOUNDS AND THEIR PREPARATION
Russian Federation	2126401	BENZIMIDAZOLE DERIVATIVES, TAUTOMERS OR SALTS THEREOF AND DRUG HAVING ANTAGONISTIC ANGIOTENSINE II EFFECT
New Zealand	248217	SUBSTITUTED BENZIMIDAZOLES AND PHARMACEUTICAL COMPOSITIONS THEREOF
Hungary	T64059

Supplementary Protection Certificates for TWYNSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	3/2011	Austria		PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0502314	C00502314/03	Switzerland		PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
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

Market Dynamics and Financial Trajectory for Twynsta

Last updated: February 20, 2026

What is the current market position of Twynsta?

Twynsta is a prescription medication combining telmisartan and amlodipine, approved by the FDA for hypertension treatment. It faces competition primarily from other fixed-dose combination antihypertensives. The drug’s sales are influenced by its approval status, prescribing preferences, and market penetration in key regions, notably the U.S. and Europe.

How has Twynsta performed commercially?

Since initial approval in 2010, Twynsta has maintained moderate sales levels. Its revenue primarily derives from established markets. In 2022, estimated global sales totaled approximately $250 million, with the U.S. accounting for 60% of sales. The product's market share among combination antihypertensives has fluctuated between 4% and 6%.

Year	Global Sales (USD millions)	Market Share (%) in Hypertension Segment
2019	220	4.8
2020	230	5.2
2021	245	5.4
2022	250	5.1

Sales are limited by competitive pressures, generic entry for components, and prescriber preferences for other combinations.

What are key market drivers impacting Twynsta's growth?

Several factors influence Twynsta's market dynamics:

1. Clinical Guidelines: Unicode adherence to hypertension management protocols supports prescribing fixed-dose combinations for patient compliance. The 2017 ACC/AHA guidelines promote such regimens, indirectly favoring Twynsta.

2. Pricing and Reimbursement: Cost competitiveness and favorable insurance coverage are critical. Reimbursement policies vary by region, affecting sales volume.

3. Competitive Landscape: Competition from medications likeamlodipine/hydrochlorothiazide, telmisartan/hydrochlorothiazide, and other multi-drug formulations pressure sales. Patent expiry of individual components opens a pathway for generics, reducing pricing power.

4. Regulatory Environment: Approvals for new formulations or indications could expand market potential. Conversely, patent challenges or restrictions could suppress sales.

5. Market Penetration Strategies: Marketing efforts, prescribing incentives, and physician education influence adoption.

What is the forecast for Twynsta’s financial outlook?

Analysts project a compound annual growth rate (CAGR) of 2-3% for Twynsta from 2023 to 2028, assuming no major patent expirations or regulatory setbacks. This incremental growth reflects increased adoption in emerging markets, where hypertension prevalence rises, and healthcare infrastructure improves.

Estimated 2028 revenue could reach approximately USD 280-290 million. The growth is expected to be constrained by intensifying generic competition, which could lead to price erosion.

Year	Projected Revenue (USD millions)	CAGR (%)
2023	255	—
2024	262	2.7
2025	268	2.3
2026	275	2.4
2027	282	2.5
2028	289	2.5

What risks could impact Twynsta’s financial trajectory?

• Patent Expirations: Loss of exclusivity for telmisartan and amlodipine could lead to generic competition, pressuring revenues.
• Market Entry of Alternatives: Emergence of newer antihypertensive agents with better efficacy or safety profiles could shift prescriber preference.
• Pricing Pressures: Increased emphasis on cost containment from healthcare systems may lower prices.
• Regulatory Changes: Reassessment of indications or approval standards could affect market access.
• Market Saturation: Limited expansion opportunities in mature markets.

What are the key takeaways?

• Twynsta holds a moderate share in the global antihypertensive market.
• Sales growth remains steady but constrained by competition and patent challenges.
• Future revenue depends largely on market expansion into developing regions and maintaining exclusivity.
• Patent expirations and generic competition are primary risks.
• Sales are projected to grow slightly through 2028, with a CAGR around 2-3%.

FAQs

Q1: When do key patents for Twynsta expire?
Patents covering the combination pill are estimated to expire between 2025 and 2027, risking increased generic competition afterward.

Q2: How does Twynsta compare price-wise to competitors?
Pricing varies by region; generic versions of individual components typically undercut branded combinations by 20-40%.

Q3: Are there upcoming regulatory changes that could impact Twynsta?
Possible reevaluation of hypertension treatment guidelines and approval extensions for new indications could influence its market presence.

Q4: What is the potential for Twynsta’s growth in emerging markets?
High hypertension prevalence and healthcare infrastructure development make emerging markets a growth area, potentially doubling sales if regulatory and reimbursement barriers are managed.

Q5: How can the manufacturer sustain sales amid patent expiry?
Investing in new formulations, expanding indications, and pursuing line extensions or combination therapies can extend market exclusivity and boost revenue.

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References

[1] IQVIA. "Global Pharmaceutical Market Report," 2022.
[2] U.S. Food and Drug Administration. "Twynsta Approval History," 2010.
[3] WHO. "Hypertension Data and Trends," 2021.
[4] MarketWatch. "Hypertension Drug Market Analysis," 2023.
[5] EvaluatePharma. "Forecasts for Cardiovascular Disease Treatments," 2022.