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ADDYI Drug Patent Profile

Which patents cover Addyi, and when can generic versions of Addyi launch?

Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in twenty-nine countries.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.

DrugPatentWatch^® Generic Entry Outlook for Addyi

Addyi was eligible for patent challenges on August 18, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 9, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ADDYI

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	604
Drug Prices:	Drug price information for ADDYI
What excipients (inactive ingredients) are in ADDYI?	ADDYI excipients list
DailyMed Link:	ADDYI at DailyMed

See drug prices for ADDYI

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

Constraining patent/regulatory exclusivity:

7,151,103

NDA:

022526

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 ADDYI

Mechanism of Action

P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ADDYI

ADDYI is protected by one US patents.

This potential generic entry date is based on patent 7,151,103.

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
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes	7,151,103

Expired US Patents for ADDYI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	7,420,057
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	8,227,471
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	9,468,639

International Patents for ADDYI

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

Country	Patent Number	Title	Estimated Expiration
China	101347431
South Korea	20040023704
Ukraine	76767	СТАБИЛЬНАЯ ПОЛИМОРФНАЯ МОДИФИКАЦИЯ ФЛИБАНСЕРИНА, СПОСОБ ЕЕ ПРОМЫШЛЕННОГО ПОЛУЧЕНИЯ И ЕЕ ИСПОЛЬЗОВАНИЕ ДЛЯ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ;СТАБІЛЬНА ПОЛІМОРФНА МОДИФІКАЦІЯ ФЛІБАНСЕРИНУ, СПОСІБ ЇЇ ПРОМИСЛОВОГО ОДЕРЖАННЯ ТА ЇЇ ЗАСТОСУВАННЯ ДЛЯ ОДЕРЖАННЯ ЛІКАРСЬКИХ ЗАСОБІВ (stable polymorph modification of flibanserin, method for industrial production thereof and use thereof for preparing medicaments)
Germany	60211937
China	1551879

ADDYI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Addyi

Introduction

Addyi, also known as flibanserin, was approved by the FDA in 2015 as a treatment for hypoactive sexual desire disorder (HSDD) in women. Marketed as the "female Viagra," it was expected to revolutionize the treatment of female sexual dysfunction. However, the drug's performance has been marred by numerous challenges, leading to a tumultuous financial trajectory.

Acquisition and Initial Expectations

Valeant Pharmaceuticals Inc. acquired Sprout Pharmaceuticals, the manufacturer of Addyi, for $1 billion in August 2015. This acquisition was seen as a strategic move to enter the women's health market, with high expectations for Addyi's sales potential. Valeant predicted that Addyi could generate annual sales between $100 million and $300 million, and even as high as $1 billion[1][2].

Marketing and Sales Efforts

Upon its launch, Valeant devoted significant resources to marketing and selling Addyi. The company allocated at least $200 million for marketing, R&D, and other expenses related to the drug from January 2016 to June 2017. Additionally, Valeant employed 148 sales reps and eight medical science liaisons to support the drug's rollout[1].

Challenges and Controversies

Despite these efforts, Addyi faced several challenges that hindered its sales. The drug's efficacy was questioned, with the FDA describing it as offering only "modest" benefits. Public health advocates, such as Public Citizen founder Sidney Wolfe, M.D., raised concerns about the drug's safety, highlighting serious risks with little benefit[2].

The marketing strategy itself was also controversial. Sprout Pharmaceuticals had created a fake consumer advocacy campaign, "Even the Score," to pressure the FDA into approving the drug. This campaign was criticized for its manipulative tactics and for creating a condition (HSDD) to sell the drug[4].

Sales Performance

The actual sales of Addyi were far below expectations. In the first few weeks after its launch, only 227 prescriptions were filled, according to Bloomberg. By early 2016, Valeant had to significantly cut its sales guidance for Addyi, from $110 million to $115 million for the year, to just $6 million for the entire year[2][5].

Litigation and Restructuring

The poor sales performance led to legal disputes between Valeant and Sprout's former shareholders. The shareholders sued Valeant, alleging that the company had breached contractual obligations related to the marketing and sales of Addyi. This litigation was resolved as part of the deal where Valeant returned Sprout to its former owners in exchange for a 6% royalty on Addyi sales and a $25 million loan to help restart operations[1][2].

Return to Former Owners

In November 2017, Valeant decided to sell Sprout back to its former owners, marking a significant retreat from its initial investment. This move allowed Valeant to streamline its portfolio, reduce complexity, and focus on its core businesses in eye health, gastroenterology, and dermatology[1].

Post-Valeant Strategies

After regaining control, Sprout's CEO, Cindy Eckert, implemented several strategies to boost Addyi's sales. These included slashing the drug's price from $800 per month to $400 per month, and later to $99 per month for uninsured patients. Additionally, Sprout set up a telemedicine portal to facilitate prescriptions and a mail-order pharmacy system to improve accessibility[4].

Regulatory Hurdles

Despite these efforts, Addyi continued to face regulatory hurdles. The FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) required physicians to complete a brief educational module before prescribing the drug, which many physicians were reluctant to do. This, combined with the need for pharmacies to train staff on dispensing requirements, further limited the drug's availability[4].

Financial Impact

The financial impact of Addyi's poor performance was significant. Valeant's $1 billion investment yielded minimal returns, with the drug generating only about $8 million in sales in 2017. The company's decision to sell Sprout and retain a 6% royalty was seen as a necessary step to cut losses and focus on more profitable ventures[2][4].

Key Takeaways

• High Expectations, Low Returns: Addyi's sales were far below the predicted $100 million to $300 million annual range.
• Controversial Marketing: The drug's approval and marketing were marred by controversy, including a fake consumer advocacy campaign.
• Regulatory Challenges: The FDA-mandated REMS and other regulatory requirements hindered the drug's accessibility.
• Financial Struggles: Valeant's $1 billion investment in Sprout yielded minimal returns, leading to a significant financial loss.
• Strategic Retreat: Valeant sold Sprout back to its former owners to focus on core businesses.

FAQs

Q: What was the initial expectation for Addyi's sales when it was launched?

A: Valeant predicted that Addyi could generate annual sales between $100 million and $300 million, and even as high as $1 billion.

Q: Why did Addyi's sales perform so poorly?

A: Addyi faced several challenges, including questionable efficacy, high pricing, and regulatory hurdles such as the FDA-mandated REMS.

Q: What was the outcome of the litigation between Valeant and Sprout's former shareholders?

A: The litigation was resolved as part of the deal where Valeant returned Sprout to its former owners in exchange for a 6% royalty on Addyi sales and a $25 million loan.

Q: How did Sprout's CEO, Cindy Eckert, attempt to boost Addyi's sales after regaining control?

A: Eckert slashed the drug's price, set up a telemedicine portal, and established a mail-order pharmacy system to improve accessibility.

Q: What were some of the regulatory hurdles that Addyi faced?

A: The FDA-mandated REMS required physicians to complete an educational module before prescribing the drug, and pharmacies had to train staff on dispensing requirements, which many were reluctant to do.

Sources

1. BioPharma Dive: "Valeant hands Sprout back to former owners - BioPharma Dive"
2. FiercePharma: "Valeant admits defeat on Sprout, trading $1B buy for 6% royalty on Addyi"
3. Vassar Digital Library: "'Female Viagra' and the intersection of medicine, gender, and desire"
4. The Hastings Center: "Addyi Rises Again"
5. BioSpace: "Female Sex Drug Addyi Not Sprouting Sales for Valeant"