ROZEREM Drug Patent Profile

When do Rozerem patents expire, and what generic alternatives are available?

Rozerem is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ROZEREM is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rozerem

A generic version of ROZEREM was approved as ramelteon by DR REDDYS LABS SA on July 26^th, 2013.

Summary for ROZEREM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	46
Patent Applications:	2,109
Drug Prices:	Drug price information for ROZEREM
What excipients (inactive ingredients) are in ROZEREM?	ROZEREM excipients list
DailyMed Link:	ROZEREM at DailyMed

See drug prices for ROZEREM

Recent Clinical Trials for ROZEREM

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Rhode Island Hospital	Phase 4
State University of New York at Buffalo	Phase 4

See all ROZEREM clinical trials

Pharmacology for ROZEREM

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Paragraph IV (Patent) Challenges for ROZEREM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ROZEREM	Tablets	ramelteon	8 mg	021782	2	2009-07-22

US Patents and Regulatory Information for ROZEREM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	AB	RX	Yes	Yes

Expired US Patents for ROZEREM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	10,098,866
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	6,034,239

International Patents for ROZEREM

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

Country	Patent Number	Title	Estimated Expiration
Japan	2004300160	MEDICAL PREPARATION CONTAINING COPOLYBIDONE
Australia	706610
Japan	3633895
Denmark	0885210
World Intellectual Property Organization (WIPO)	9732871

ROZEREM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of ROZEREM (Ramelteon)

Introduction to ROZEREM

ROZEREM (ramelteon) is a prescription sleep medication approved by the U.S. Food and Drug Administration (FDA) in 2005 for the treatment of insomnia characterized by difficulty with sleep onset. It is notable for being the first and only non-scheduled prescription sleep medication, meaning it has no evidence of abuse and dependence and is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA)[1].

Unique Mechanism of Action

ROZEREM works by selectively targeting two receptors in the brain's suprachiasmatic nucleus (SCN), the body's "master clock" that regulates the sleep-wake cycle. This unique mechanism of action sets it apart from other sleep medications, which often have different modes of action and may carry risks of addiction[1].

Clinical Trials and Safety Profile

The FDA approval of ROZEREM was based on extensive clinical research involving over 4,200 patients aged 18 to 93. These studies demonstrated the safety and efficacy of ROZEREM for long-term use, including its safety in older adults and those with mild-to-moderate chronic obstructive pulmonary disease (COPD) and mild-to-moderate sleep apnea. However, it is not recommended for patients with severe hepatic impairment, severe sleep apnea, or severe COPD[1].

Market Launch and Initial Reception

Following its approval, ROZEREM was launched in late 2005. The initial marketing campaign, which included a memorable ad featuring Abe Lincoln and a beaver, generated significant buzz but was slow to translate into substantial sales. In the first year after its launch, ROZEREM earned $13.3 million in sales from July to December 2005[3].

Sales Growth and Market Performance

Despite the slow start, ROZEREM's sales gradually increased. By 2007, the drug had earned $28.1 million in the first quarter, outpacing Sonata in the total sleep aid category, although it still lagged behind other major sleep aids like Lunesta and Ambien. By this time, annual sales had risen to $76.2 million, indicating a growing market presence[3].

In subsequent years, ROZEREM continued to gain traction. By May 2019, the Rozerem brand had U.S. sales of approximately $91.3 million for the most recent twelve months, according to IQVIA[5].

Generic Competition

The market dynamics for ROZEREM changed significantly with the introduction of generic versions. In 2019, Dr. Reddy's Laboratories launched generic ramelteon tablets, and by 2020, Upsher-Smith Laboratories also introduced their generic version, which was AB-rated to the branded ROZEREM product. The generic market had U.S. sales of approximately $26 million for the 12 months ending October 2020[4][5].

Financial Impact of Generic Competition

The introduction of generic versions significantly impacted the financial trajectory of the branded ROZEREM. Generic competition typically leads to a decline in sales for the branded product as patients and healthcare providers opt for the more affordable generic alternatives. This shift is evident in the sales figures, where the branded ROZEREM saw a decline in market share and revenue following the launch of generics.

Marketing Strategies and Consumer Awareness

The marketing campaign for ROZEREM was criticized for not adequately informing consumers about the drug's unique mechanism of action and its nonaddictive nature. Experts suggested that more emphasis should have been placed on these aspects to differentiate ROZEREM from other sleep aids and to drive sales more effectively[3].

Regulatory and Safety Considerations

ROZEREM's regulatory approval and safety profile have been crucial in its market success. The drug's lack of abuse potential and its approval for long-term use have made it an attractive option for patients and healthcare providers. However, it is important to note that ROZEREM can have side effects such as somnolence, dizziness, and fatigue, and it should be used with caution, especially when combined with alcohol or other medications[1].

Conclusion

ROZEREM's market dynamics and financial trajectory have been shaped by its unique mechanism of action, clinical trial outcomes, marketing strategies, and the introduction of generic competition. While it initially faced challenges in gaining significant market share, ROZEREM established itself as a viable option for treating insomnia. The launch of generic versions has altered its financial trajectory, but it remains an important player in the sleep aid market.

Key Takeaways

• Unique Mechanism of Action: ROZEREM targets the suprachiasmatic nucleus (SCN) without the risk of addiction.
• Clinical Trials: Extensive clinical research supported its safety and efficacy for long-term use.
• Market Launch: Initial sales were slow, but the drug gained traction over time.
• Generic Competition: The introduction of generic versions significantly impacted branded ROZEREM sales.
• Marketing Strategies: Emphasis on the drug's nonaddictive nature and unique mechanism could have improved sales.
• Regulatory and Safety Considerations: Approved for long-term use with a favorable safety profile.

FAQs

What is ROZEREM used for?

ROZEREM (ramelteon) is used for the treatment of insomnia characterized by difficulty with sleep onset.

Why is ROZEREM unique?

ROZEREM is the first and only prescription sleep medication that has no evidence of abuse and dependence, and it is not classified as a controlled substance by the U.S. DEA. It also has a novel therapeutic mechanism of action targeting the SCN.

What are the common side effects of ROZEREM?

The most common adverse events associated with ROZEREM include somnolence, dizziness, and fatigue.

Can ROZEREM be used long-term?

Yes, ROZEREM is approved for long-term use in adults.

How has generic competition affected ROZEREM sales?

The introduction of generic versions of ramelteon has significantly reduced the sales of the branded ROZEREM product, as patients and healthcare providers opt for the more affordable generic alternatives.

Sources

1. Takeda Pharmaceuticals North America, Inc. - FDA Approved ROZEREM™ (ramelteon), First and Only Non-Scheduled Prescription Sleep Medication.
2. VANDA PHARMACEUTICALS INC. - Annual Reports.
3. Pharmaceutical Executive - Direct to Consumer: A Dream Campaign.
4. Upsher-Smith Laboratories, LLC - Upsher-Smith Launches Ramelteon Tablets.
5. Dr. Reddy's Laboratories - Dr. Reddy's Laboratories Announces the Launch of Ramelteon Tablets in the U.S. Market.