Counterfeit Versions of Cialis tablets identified entering the United States

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7.1 Potential for Pharmacodynamic Interactions with CIALIS
See also:
Drug Label Information
How to switch from Cialis to tadalafil
5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

"Executing on our strategy of targeted acquisitions, Cialis® will expand our existing portfolio in the region and strengthen Grünenthal's Latin American business", says Gabriel Baertschi, CEO, Grünenthal. "In 2022, we acquired Nebido®, a long-acting treatment for testosterone deficiency, and with Cialis® we can continue to serve our existing customer base and foster our growth in key Latin American markets." Through the acquisition of Cialis®, Grünenthal continues executing its strategy of acquiring established medicines to expand its portfolio and increase its profitability.

Follow-up with a doctor is important after starting Cialis.
Report any persistent or severe side effects immediately.
Efficacy should be assessed; the dose may need adjustment.
Underlying causes of ED or BPH should continue to be investigated.
Regular check-ups are needed to monitor cardiovascular health.
Discuss if the treatment still meets your needs and expectations.
Do not stop or change your dose without consulting your doctor.

Since 2017, Grünenthal has invested over €2 billion in the acquisition of established medicines, including Nebido®, the European rights to Crestor® and Nexium®, as well as the global rights to Vimovo® (excluding the U.S.

Active Ingredient	Dosage (mg)	Added Ingredients	Formulation Type
Tadalafil	20	L-arginine, Ginseng	Tablet
Tadalafil	10	Maca root, Zinc	Capsule
Sildenafil	50	Bioperine, Rhodiola	Sachet
Vardenafil	20	L-citrulline	Tablet

and Japan), Qutenza® and Zomig® (excluding Japan).

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"Tadalafil (Cialis) and Vardenafil (Levitra) Recently Approved Drugs for Erectile Dysfunction". Archived from the original on 14 July 2016. "Potency, selectivity, and consequences of nonselectivity of PDE inhibition". "Deep Pockets + Intense Research + Total Control = The Formula -- Bothell Biotech Icos Keeps The Pipeline Full Of Promise". Archived from the original on 24 February 2012.

TUFTS Clinical Trial Material Round Table

"2,5-Diketopiperazines: synthesis, reactions, medicinal chemistry, and bioactive natural products". "An overview of the key routes to the best selling 5-membered ring heterocyclic pharmaceuticals". Archived from the original on 17 October 2014. Archived from the original on 29 April 2015. ^ "FDA approves tadalafil for pulmonary arterial hypertension". In 2023, Grünenthal established Grünenthal Meds, a joint venture with Kyowa Kirin International, which manages a portfolio of 13 brands primarily focused on pain management and, in 2024, acquired the US company Valinor Pharma and the product Movantik®.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	60mg	360 + 10 Pills	570.52€ 543.35€
Cialis Generic	5mg	360 + 10 Pills	268.08€ 255.31€
Cialis Black	80mg	30 + 2 Pills	89.11€ 84.87€
Cialis Professional	20mg	270 + 6 Pills	623.07€ 593.40€
Cialis Generic	10mg	30 + 4 Pills	63.32€ 60.30€
Cialis Black	80mg	90 + 6 Pills	207.88€ 197.98€
Cialis Generic	20mg	20 Pills	54.72€ 52.11€
Cialis Generic	2.5mg	180 + 10 Pills	154.86€ 147.49€
Cialis Generic	5mg	120 + 6 Pills	132.92€ 126.59€
Cialis Original	20mg	64 + 4 Pills	274.18€ 261.12€
Cialis Professional	20mg	10 Pills	48.29€ 45.99€

1 In Mexico Cialis® is indicated for the oral treatment of erectile dysfunction and symptoms of benign prostatic hyperplasia in adult men. About Grünenthal Grünenthal is a global leader in pain management and cialis oral strips related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain.

7.1 Potential for Pharmacodynamic Interactions with CIALIS

"First they tried to play it safe; Ads for erectile dysfunction drug Cialis bared all - including a scary potential side effect. It was risky but it has paid off". Archived from the original on 14 December 2019. "Two Pills Look to Topple Viagra's Reign in Market; Levitra Expects Approval Next Month, Cialis Later This Year". Archived from the original on 24 January 2021.

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Archived from the original on 10 September 2015. Archived from the original (PDF) on 29 August 2021. Archived from the original on 9 November 2021. "Daily low-dose tadalafil may reduce the penile curvature progression rate in patients with acute Peyronie's disease: a retrospective comparative analysis". "PD21-09 Daily Tadalafil Therapy: A New Treatment Option for Peyronie's Disease?". Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. In 2024, Grünenthal employed around 4,300 people and achieved revenues of €1.8 billion.

Drug Label Information

The transaction is expected to close in the third quarter of 2025, subject to the satisfaction of customary closing conditions. Grünenthal will finance the transaction using available liquidity. The financial terms of the transaction are not disclosed. Cialis® is indicated for the oral treatment of erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in adult men1. The acquisition will expand Grünenthal's Latin American Men's Health product portfolio. ZP Therapeutics, the commercial division of Zuellig Pharma, will promote the two brands in the relevant markets.

Key advantages over other ED pills include a longer 36-hour window.
This allows for more spontaneous sexual activity.
The daily low-dose option (2.5 mg or 5 mg) provides continuous readiness.
It can be taken with or without food, unlike some competitors.
Alcohol in moderation does not significantly reduce its efficacy.
It is less affected by high-fat meals compared to sildenafil.
The daily dose also consistently manages BPH symptoms.

Prior to the acquisition, ZP Therapeutics was responsible for the promotion and distribution of the brands as part of a broader, long-term strategic partnership with Lilly in Brunei, Indonesia, Malaysia, Philippines and Thailand.

How to switch from Cialis to tadalafil

"Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US". ^ "Non-Arteritic Anterior Ischemic Optic Neuropathy - Brigham and Women's Hospital". Archived from the original on 28 October 2021. ^ Penedones A, Alves C, Batel Marques F (February 2020). "Risk of nonarteritic ischaemic optic neuropathy with phosphodiesterase type 5 inhibitors: a systematic review and meta-analysis".

How long does tadalafil last?

^ "FDA Announces Revisions to Labels for Cialis, Levitra and Viagra". U.S. Food and Drug Administration (FDA). Archived from the original on 22 October 2016. "Droperidol is predominantly metabolized by human CYP3A enzymes". “This acquisition marks a major milestone in the evolution of Zuellig Pharma to becoming an integrated healthcare solutions company.

Cialis is FDA-approved for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH).
For BPH, it helps relax prostate and bladder muscles to improve urine flow.
It can be prescribed for both conditions simultaneously (ED+BPH).
The starting dose for daily BPH treatment is typically 5 mg.
Clinical trials showed significant improvement in BPH symptoms.
It is not approved for use in women or children.
Off-label uses exist but are not officially recommended by Lilly.

It demonstrates the increasing strength of ZP Therapeutics, which has extensive in-market expertise and capabilities in driving growth of healthcare products in Asia. We look forward to further expanding our commercial presence in the region through meaningful strategic partnerships with the world’s leading biopharma companies as we remain focused on our purpose of making healthcare more accessible to communities in Asia,” said John Graham, Group CEO, Zuellig Pharma. Zuellig Pharma is a leading healthcare solutions company in Asia, and our mission is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital and commercial services to support the growing healthcare needs in this region. The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 16 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world. ZP Therapeutics, a division of Zuellig Pharma, is the commercialisation partner of choice for the healthcare industry with offices in 13 countries across Asia and over 2,500 associates. A catalyst in improving patient journeys and healthcare outcomes through commercial excellence, robust in-market capabilities and strong ethical principles, ZP Therapeutics is a trusted partner for expanding patient access and providing innovations to the healthcare community. FDA is alerting consumers and health care professionals that counterfeit versions of Cialis 20 mg tablets were found in the mail on its way to a U.S. consumer. While this shipment was stopped, FDA is concerned about other possible mail shipments to consumers. FDA laboratory analysis showed the counterfeit versions contain multiple active ingredients, which if used could result in adverse effects or harm. Consumers should only buy prescription medicines from state-licensed pharmacies located in the U.S. FDA cannot confirm that the manufacturing, quality, storage, and handling of these products follow U.S. standards because these products are from an unknown source.

Tip	Explanation	Additional Advice
Consult a doctor beforehand	Especially if taking other medications or health conditions	Essential for safety
Follow recommended dosage	Avoid overdose, which can cause adverse effects	Check label instructions
Do not combine with nitrates	Can cause dangerous drops in blood pressure	Seek medical advice
Monitor for side effects	Report any severe reactions to a healthcare provider	Immediate consultation

Therefore, these products are considered unsafe and should not be used. FDA also recommends consumers talk to their health care professional about their condition and options for treatment if they received a counterfeit product. FDA-approved Cialis tablets made by Eli Lilly contain the active ingredient, tadalafil, and are used for the treatment of erectile dysfunction and other approved indications.

5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

Grünenthal announces that it agreed to acquire the commercial rights to Cialis® from Eli Lilly and Company in Mexico, Brazil and Colombia, further strengthening Grünenthal's footprint in Latin America. As part of the acquisition, Grünenthal will transfer the manufacturing of Cialis® to its production site in Chile. Since 2017, Grünenthal has invested more than €2 billion in successful M&A transactions, significantly strengthening its profitability. Aachen, Germany, 2 June 2025 – Grünenthal today announced the acquisition of the commercial rights to Cialis® (tadalafil) in Mexico, Brazil and Colombia from Eli Lilly and Company. Over the next few years, Grünenthal and Lilly will work together to transfer the manufacturing to Grünenthal's production site in Santiago, Chile, that will supply Cialis® for Mexico, Brazil and Colombia moving forward. Currently, Eli Lilly’s authentic product is considered safe and effective for its intended uses.

Variant Name	Active Ingredient	Potency	Available Forms	Price Range (USD)
Cialis Lily Classic	Tadalafil 10 mg	Moderate	Tablet	15-30
Cialis Lily Forte	Tadalafil 20 mg	High	Capsule	25-45
Cialis Lily Mini	Tadalafil 5 mg	Low	Chewable Tablet	10-20
Cialis Lily Ultra	Vardenafil 10 mg	Moderate	Tablet	20-40