ALYQ Drug Patent Profile

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

Alyq is a drug marketed by Teva Pharms Inc and Teva Pharms Usa and is included in two NDAs.

The generic ingredient in ALYQ is tadalafil. There are twenty-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alyq

A generic version of ALYQ was approved as tadalafil by TEVA PHARMS USA on May 22^nd, 2018.

Summary for ALYQ

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	107
Patent Applications:	6,285
Drug Prices:	Drug price information for ALYQ
DailyMed Link:	ALYQ at DailyMed

See drug prices for ALYQ

Pharmacology for ALYQ

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for ALYQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	ALYQ	tadalafil	TABLET;ORAL	216932-001	Oct 12, 2022	AB2	RX	No	No
Teva Pharms Usa	ALYQ	tadalafil	TABLET;ORAL	209942-001	Feb 5, 2019	AB2	RX	No	No

EU/EMA Drug Approvals for ALYQ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Limited	Talmanco (previously Tadalafil Generics)	tadalafil	EMEA/H/C/004297 Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.	Authorised	yes	no	no	2017-01-09
Eli Lilly Nederland B.V.	Tadalafil Lilly	tadalafil	EMEA/H/C/004666 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Lilly is not indicated for use by women.Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.	Authorised	no	no	no	2017-03-22
Eli Lilly Nederland B.V.	Adcirca (previously Tadalafil Lilly)	tadalafil	EMEA/H/C/001021 AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.	Authorised	no	no	no	2008-10-01
Eli Lilly Nederland B.V.	Cialis	tadalafil	EMEA/H/C/000436 Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.	Authorised	no	no	no	2002-11-12
Mylan Pharmaceuticals Limited	Tadalafil Mylan	tadalafil	EMEA/H/C/003787 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women.	Authorised	yes	no	no	2014-11-21

ALYQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALYQ (Generic Tadalafil)

Introduction to ALYQ

ALYQ, the generic version of tadalafil, was launched by Teva Pharmaceutical Industries Ltd. in 2020. This drug is a significant player in the erectile dysfunction (ED) treatment market, offering an affordable alternative to brand-name medications like Cialis.

Market Drivers

Increased Accessibility and Awareness

The launch of ALYQ has contributed to the growing accessibility of ED treatments. Public awareness about ED medications has been on the rise, partly due to educational campaigns and the wider availability of these medications through online providers and hospital pharmacies. This increased awareness has boosted sales, with phosphodiesterase-5 inhibitors, the class of drugs to which tadalafil belongs, seeing a significant increase in sales[1][4].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, present a lucrative opportunity for ALYQ. The large patient pool, improving healthcare infrastructure, and growing awareness of ED treatment options in these regions are driving market growth. Countries like China and India, with their growing purchasing power and increasing healthcare expenditure, are key drivers of this growth[1][4].

Technological Advancements and Regulatory Approvals

The development of new dose medications and regulatory approvals have been crucial for the growth of the ED drugs market. The launch of ALYQ in 2020 is a prime example of how new drug formulations can fuel market expansion[1][4].

Market Restraints

Patent Cliff Challenges

One of the significant restraints for brand-name ED medications is the patent cliff. However, for generic versions like ALYQ, this is less of an issue since they are already generic. Nevertheless, the expiration of patents on major medications can lead to increased competition from other generic versions, potentially affecting market share[1].

Regulatory Hurdles

While ALYQ has already gained regulatory approval, the process of obtaining such approvals can be challenging and time-consuming. This can delay market entry for new formulations or variations of existing drugs[3].

Financial Trajectory

Revenue Growth

The ED treatment drugs market, which includes ALYQ, is projected to grow significantly. The market was valued at USD 3.31 billion in 2023 and is expected to reach USD 5.97 billion by 2032, with a compound annual growth rate (CAGR) of 6.84% during the forecast period[1].

Market Share and Competition

Teva Pharmaceuticals, the manufacturer of ALYQ, benefits from the growing demand for generic ED medications. The availability of generic alternatives like ALYQ increases competition in the market, which can drive down prices but also expands the market reach due to affordability[1][4].

Regional Performance

The Asia Pacific region is expected to be the fastest-growing market for ED treatment drugs, including ALYQ. This region's high prevalence of ED, combined with improving healthcare infrastructure and increasing awareness, makes it a key area for market expansion[1][4].

Key Players and Market Dynamics

Competitive Landscape

The ED treatment drugs market is competitive, with several key players including Teva Pharmaceuticals, Pfizer (manufacturer of Viagra), and Eli Lilly (manufacturer of Cialis). The entry of generic versions like ALYQ has increased competition, making the market more dynamic and consumer-friendly[1][4].

Distribution Channels

The distribution of ALYQ through various channels such as hospital pharmacies, retail pharmacies, and online pharmacies has made it more accessible to a wider audience. This multi-channel approach is a key factor in the market's growth[1].

Future Outlook

Growth Opportunities

The future outlook for ALYQ and the broader ED treatment market is positive. Emerging markets, technological advancements, and increased awareness are expected to continue driving growth. The Asia Pacific region, in particular, offers significant opportunities due to its large patient pool and growing healthcare infrastructure[1][4].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as regulatory hurdles and the need for continuous innovation to stay competitive. However, these challenges also present opportunities for companies to invest in R&D and expand their product portfolios[3].

Key Takeaways

• Market Growth: The ED treatment drugs market, including ALYQ, is expected to grow at a CAGR of 6.84% from 2024 to 2032.
• Emerging Markets: The Asia Pacific region is a key growth area due to its large patient pool and improving healthcare infrastructure.
• Accessibility and Awareness: Increased awareness and accessibility of ED treatments are driving market growth.
• Competition: The market is competitive, with generic versions like ALYQ increasing competition and affordability.
• Future Outlook: The future looks positive, with opportunities for growth in emerging markets and through technological advancements.

FAQs

Q: What is ALYQ, and when was it launched? A: ALYQ is the generic version of tadalafil, launched by Teva Pharmaceutical Industries Ltd. in 2020.

Q: What are the key drivers of the ED treatment drugs market? A: The key drivers include increased accessibility and awareness, emerging markets, and technological advancements.

Q: Which region is expected to be the fastest-growing for ED treatment drugs? A: The Asia Pacific region is expected to be the fastest-growing, driven by a large patient pool and improving healthcare infrastructure.

Q: What are the main restraints for the ED treatment drugs market? A: The main restraints include patent cliff challenges for brand-name medications and regulatory hurdles.

Q: What is the projected market value of the ED treatment drugs market by 2032? A: The market is expected to reach USD 5.97 billion by 2032, growing at a CAGR of 6.84% from 2024 to 2032[1].

Sources

1. Erectile Dysfunction Treatment Drugs Market Size, Share 2032 - SNS Insider
2. Financial reporting - Investors | ALK - ALK
3. Investment Trends in Pharmaceutical Research - DrugBank Blog - DrugBank
4. Erectile Dysfunction Drugs Market Statistics | Projection - 2032 - Allied Market Research
5. ALK launches new growth strategy and 2028 financial ambitions - GlobeNewswire