YASMIN Drug Patent Profile

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

Yasmin is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Yasmin

A generic version of YASMIN was approved as drospirenone; ethinyl estradiol by DR REDDYS LABS SA on September 7^th, 2010.

Summary for YASMIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	36
Drug Prices:	Drug price information for YASMIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YASMIN
What excipients (inactive ingredients) are in YASMIN?	YASMIN excipients list
DailyMed Link:	YASMIN at DailyMed

See drug prices for YASMIN

Recent Clinical Trials for YASMIN

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

Sponsor	Phase
Women's Hospital School Of Medicine Zhejiang University	Phase 4
Inonu University	N/A
University of North Carolina, Chapel Hill	Phase 2

See all YASMIN clinical trials

Paragraph IV (Patent) Challenges for YASMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for YASMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	AB	RX	Yes	Yes

Expired US Patents for YASMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	5,569,652
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,933,395
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,787,531

International Patents for YASMIN

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

Country	Patent Number	Title	Estimated Expiration
Poland	187474
Poland	199028
Germany	59713018
European Patent Office	0398460	Utilisation de la dihydrospirorénone comme agent antiandrogène (Use of dihydrospirorenone as an anti-androgen)
Spain	2211580
Germany	60041421
Germany	122009000006

Supplementary Protection Certificates for YASMIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0398460	300221	Netherlands		300221, 20100516, EXPIRES: 20150306
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
0398460	C00398460/01	Switzerland		FORMER OWNER: SCHERING AKTIENGESELLSCHAFT, DE
0398460	91065	Luxembourg		91065, EXPIRES: 20150516

YASMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Yasmin

Overview of Yasmin

Yasmin, a combination birth control pill, has been a significant player in the pharmaceutical market since its approval in 2001. It contains ethinyl estradiol (an estrogen hormone) and drospirenone (a progestin hormone), making it highly effective in preventing pregnancy and offering additional health benefits[3].

Market Position and Sales Performance

Yasmin, along with its sister drug Yaz, has been one of the best-selling oral contraceptives globally. Despite the controversies and legal challenges, these drugs have maintained a strong market presence. In 2010, Yaz was the second-best-selling product for Bayer, generating $1.5 billion in sales[4].

Regulatory and Legal Challenges

The market dynamics of Yasmin have been significantly influenced by regulatory and legal issues. The FDA has been involved in several actions related to the drug, including a request for Bayer to distribute a corrective advertisement in 2009 to address misleading claims about the drug's safety and efficacy[4].

Litigation and Settlements

Bayer has faced numerous lawsuits related to Yasmin and Yaz, particularly concerning blood clots and other serious health risks. As of 2013, there were approximately 10,000 lawsuits pending in the U.S., with an additional 1,200 unfiled claims. Bayer set aside $1 billion to settle claims from women who suffered blood clots and other injuries[2].

Safety Evaluations

The safety of Yasmin has been a contentious issue. While studies funded by Bayer suggested no higher risk of blood clots compared to other birth control pills, independent studies indicated a 50-75% increased risk of clots. This led to an FDA advisory committee review, which ultimately decided that the benefits of the drug outweighed the risks[4].

Financial Impact of Litigation and Regulatory Actions

The financial trajectory of Yasmin has been impacted by the significant legal and regulatory challenges. Bayer agreed to pay up to $24 million to settle claims related to gall bladder injuries and set aside $1 billion for blood clot-related claims. These settlements and ongoing litigation have been substantial financial burdens for the company[2].

Operating Profit and Net Present Value (NPV) Models

GlobalData's NPV model provides a comprehensive tool for evaluating the financial performance of pharmaceutical assets like Yasmin. This model includes forecasts of revenue, operating profit, net profit, and discounted cash flow to derive the NPV. Such models are crucial for strategic decision-making in the pharmaceutical industry, especially when considering the long-term financial implications of drugs with complex market dynamics[1].

Revenue Forecasting

Revenue forecasting for Yasmin involves analyzing sales data from established global firms and emerging biotechs over a 17-year period. This helps in understanding the drug's market performance and potential future earnings.

Patent Expiry and Market Impact

The patent expiry model is another critical component of the NPV analysis. As patents expire, generic versions of the drug can enter the market, potentially reducing the revenue and profitability of the original product. This needs to be factored into the financial forecasting to get an accurate picture of the drug's long-term financial trajectory.

Benefits and Market Appeal

Despite the challenges, Yasmin offers several benefits that contribute to its market appeal. It is 99% effective in preventing pregnancy when used as directed and provides additional benefits such as relief from PMS symptoms, acne treatment, and the ability to skip or shorten menstrual periods[3].

Competitive Landscape

Yasmin operates in a competitive market with other oral contraceptives. However, its unique formulation with drospirenone sets it apart, particularly in terms of reduced water retention and lower risk of weight gain compared to other birth control pills[3].

Consumer Perception and Safety Concerns

Consumer perception of Yasmin has been mixed due to the safety concerns. While many women find the drug effective and beneficial, others have raised concerns about the increased risk of blood clots and other adverse effects. This has led to a significant amount of online discussion and support groups, making it one of the most complained-about drugs on the internet[4].

Future Outlook

The future outlook for Yasmin is complex, influenced by both its market performance and the ongoing legal and regulatory challenges. As the pharmaceutical landscape evolves, the drug's financial trajectory will depend on how well Bayer navigates these challenges and maintains market share.

Market Trends and Innovations

The birth control market is continuously evolving with new products and technologies. Yasmin will need to compete with newer, potentially safer alternatives that may gain favor among consumers and healthcare providers.

Regulatory Compliance

Bayer must ensure ongoing compliance with regulatory requirements to avoid further legal and financial repercussions. This includes transparent communication about the drug's risks and benefits.

Key Takeaways

• Market Performance: Yasmin has been a top-selling oral contraceptive despite legal and regulatory challenges.
• Regulatory and Legal Issues: Significant litigation and settlements have impacted the drug's financial trajectory.
• Financial Models: NPV models are essential for evaluating the long-term financial performance of Yasmin.
• Benefits and Risks: The drug offers several health benefits but also carries risks such as blood clots.
• Consumer Perception: Mixed consumer perception due to safety concerns affects market dynamics.
• Future Outlook: The drug's future depends on navigating legal and regulatory challenges and competing with new market entrants.

FAQs

Q: What are the main ingredients in Yasmin?

Yasmin contains ethinyl estradiol (an estrogen hormone) and drospirenone (a progestin hormone)[3].

Q: How effective is Yasmin in preventing pregnancy?

Yasmin is 99% effective in preventing pregnancy when used as directed[3].

Q: What are some of the additional benefits of using Yasmin?

Yasmin provides relief from PMS symptoms, treats acne, and allows users to skip or shorten menstrual periods[3].

Q: What are the common side effects of Yasmin?

Common side effects include stomach aches, vomiting, bloating, headaches, and increased risk of blood clots, especially for smokers over 35 years old[3].

Q: How has litigation affected the financial performance of Yasmin?

Bayer has set aside significant funds to settle claims related to blood clots and other injuries, impacting the drug's financial trajectory[2].