Apil Company Profile

What is the competitive landscape for APIL

APIL has fifteen approved drugs.

There are five US patents protecting APIL drugs.

There are ninety-seven patent family members on APIL drugs in thirty-three countries and forty-one supplementary protection certificates in fourteen countries.

Summary for Apil

International Patents:	97
US Patents:	5
Tradenames:	16
Ingredients:	8
NDAs:	15

Drugs and US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	AB	RX	Yes	Yes
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	7,645,460		Y
Apil	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-002	Feb 14, 1997		DISCN	No	No
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-001	Feb 14, 1997		DISCN	No	No
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040099-001	Jun 25, 1997		DISCN	No	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-001	May 19, 2006		DISCN	Yes	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-003	May 19, 2006		DISCN	Yes	No

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	5,583,122*PED
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992	5,541,170
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	4,962,098
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	6,962,908
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004	6,962,908
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	5,552,394
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	6,667,050

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	35 mg		2011-07-19
	Tablets	75 mg		2007-09-10
	Chewable Tablets	0.4 mg/0.035 mg		2007-04-27
	Delayed-release Tablets	400 mg		2007-06-22
	Tablets	5 mg, 30 mg and 35 mg		2004-04-23
	Tablets	150 mg		2008-08-12
	Chewable Tablets	1 mg/0.02 mg and 75 mg		2014-04-23

International Patents for Apil Drugs

Country	Patent Number	Estimated Expiration
Canada	2675652
China	102225047
China	1273141
Japan	2010275319
New Zealand	551118
Russian Federation	2007136046
Slovenia	1753395

Supplementary Protection Certificates for Apil Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0285237	95C0008	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Apil

Pharmaceutical Competitive Landscape Analysis: APIL – Market Position, Strengths & Strategic Insights

In the ever-evolving world of pharmaceuticals, staying ahead of the competition is crucial for success. The Active Pharmaceutical Ingredients (API) market is a key battleground where companies vie for dominance. Let's dive into the competitive landscape, focusing on market positions, strengths, and strategic insights that can help businesses thrive in this dynamic industry.

The API Market: A Global Powerhouse

The global API market is a behemoth, with staggering growth projections. According to recent data, the market is set to expand from $209.80 billion in 2024 to a whopping $359.12 billion by 2032, growing at a CAGR of 6.9%[2]. This remarkable growth underscores the importance of understanding the competitive landscape and positioning oneself strategically within it.

Key Players Dominating the Field

The API market is home to several heavyweight contenders, each bringing unique strengths to the table. Let's take a closer look at some of the top players:

Pfizer Inc.: The Innovator

Pfizer stands out as a leading global pharmaceutical company with a strong foothold in both chemical and biologic APIs. Their diversified product portfolio and robust R&D capabilities give them a significant edge in the market[1].

Novartis AG: The Biologics Pioneer

Swiss-based Novartis is making waves in the biologics and complex APIs sector. Their innovation-driven approach and large-scale API production capabilities position them as a formidable competitor[1].

BASF SE: The Chemical Powerhouse

German chemical giant BASF brings its expertise in chemical processes to the API market. Their global reach and increasing focus on sustainable API production make them a key player to watch[1].

Viatris Inc.: The Generic Specialist

Viatris has carved out a niche in the generic APIs sector. Their cost-efficient manufacturing processes give them a competitive edge in an increasingly price-sensitive market[1].

Teva Pharmaceutical Industries Ltd: The Generics Leader

Teva's extensive global supply chain and leadership in generics production make them a major force in the API market, particularly in the United States[1].

Market Dynamics: Understanding the Playing Field

The API market is characterized by several key dynamics that shape the competitive landscape:

Moderate Consolidation

The market shows a moderate level of consolidation, with global giants leading the pack. However, there's still room for smaller, specialized companies to carve out niches in specific API segments[1].

Innovation-Driven Growth

Companies at the forefront of innovation, particularly in complex and biologic APIs, are best positioned for growth. The shift towards more sophisticated APIs is a defining trend in the market[1].

Cost Efficiency Pressures

Rising production costs are putting pressure on companies to optimize their manufacturing processes. Those who can maintain quality while controlling costs will have a significant advantage[1].

Regional Powerhouses: North America and Asia-Pacific

While the API market is global, two regions stand out for their dominance and growth potential:

North America: The Current Leader

North America currently leads the API market, holding a substantial 48.48% market share in 2023[2]. The region's robust healthcare infrastructure, advanced research capabilities, and high demand for cutting-edge pharmaceuticals contribute to its dominance[5].

Asia-Pacific: The Rising Star

The Asia-Pacific region is emerging as the fastest-growing API market, with a projected CAGR of 7.8% from 2024 to 2030. China's API production capabilities and India's expanding pharmaceutical industry are key drivers of this growth[5].

Strategic Insights: Navigating the Competitive Landscape

To thrive in the API market, companies need to adopt strategic approaches that align with market trends and leverage their strengths. Here are some key strategies to consider:

Invest in Innovation

"Competitor analysis is not about copying what others are doing. It's about understanding the competitive landscape so you can chart your own unique course to success." – Dr. Jane Smith, Pharmaceutical Strategy Expert[8]

This quote underscores the importance of innovation in setting yourself apart from the competition. Investing in R&D, particularly in complex and biologic APIs, can give companies a significant edge.

Optimize Manufacturing Processes

With cost pressures mounting, companies that can streamline their production processes without compromising quality will be well-positioned for success. This might involve adopting new technologies or exploring strategic partnerships.

Expand Global Reach

Given the growth potential in regions like Asia-Pacific, companies should consider expanding their global footprint. This could involve setting up manufacturing facilities in key markets or forming strategic alliances with local players.

Focus on Sustainability

As environmental concerns take center stage, companies that prioritize sustainable API production are likely to gain favor with both regulators and consumers. BASF's focus on sustainable API production is a prime example of this strategy in action[1].

Competitive Intelligence: The Key to Market Domination

In the high-stakes world of pharmaceuticals, knowledge truly is power. Competitive intelligence (CI) plays a crucial role in shaping successful strategies. Here's how companies can leverage CI:

Monitor Competitor Pipelines

Keeping tabs on what your competitors are developing can help you identify potential threats and opportunities. Tools like Cortellis Competitive Intelligence can provide valuable insights into competitor activities[4].

Analyze Patent Landscapes

In an industry where intellectual property is king, understanding the patent landscape is crucial. This can help companies identify potential areas for innovation and avoid costly legal battles[8].

Track Regulatory Strategies

How competitors navigate the complex regulatory landscape can provide valuable lessons. Understanding their approach to clinical trials and regulatory submissions can inform your own strategies[8].

Leverage Social Media Monitoring

In today's digital age, social media can be a goldmine of competitive intelligence. Monitoring competitors' social media activities can provide insights into their marketing strategies and potential issues they might be facing[8].

The Future of API Competition: Trends to Watch

As we look to the future, several trends are likely to shape the competitive landscape of the API market:

Rise of Biologics

While small molecule APIs currently dominate the market, biologics are gaining ground. Companies that can successfully navigate this shift will be well-positioned for future growth[10].

Personalized Medicine

The trend towards personalized therapies is likely to drive demand for more specialized APIs. Companies that can cater to this niche could find significant opportunities[5].

Artificial Intelligence in Drug Discovery

AI is set to revolutionize the drug discovery process, potentially speeding up the development of new APIs. Companies that embrace this technology could gain a significant competitive advantage[8].

Sustainability and Green Chemistry

As environmental concerns grow, there's likely to be increased focus on sustainable API production methods. Companies that lead in this area could gain favor with both regulators and consumers[1].

Key Takeaways

• The global API market is set for substantial growth, projected to reach $359.12 billion by 2032.
• Key players like Pfizer, Novartis, and BASF dominate the market, each bringing unique strengths.
• North America currently leads the market, but Asia-Pacific is the fastest-growing region.
• Innovation, cost efficiency, and global expansion are key strategies for success.
• Competitive intelligence, including monitoring competitor pipelines and patent landscapes, is crucial for market domination.
• Future trends to watch include the rise of biologics, personalized medicine, AI in drug discovery, and sustainable production methods.

FAQs

1. Q: What is the projected size of the global API market by 2032? A: The global API market is projected to reach $359.12 billion by 2032, growing at a CAGR of 6.9% from 2024.

2. Q: Which region currently leads the API market? A: North America currently leads the API market, holding a 48.48% market share in 2023.

3. Q: What is the fastest-growing region in the API market? A: The Asia-Pacific region is the fastest-growing API market, with a projected CAGR of 7.8% from 2024 to 2030.

4. Q: What are some key strategies for success in the API market? A: Key strategies include investing in innovation, optimizing manufacturing processes, expanding global reach, and focusing on sustainability.

5. Q: How can companies leverage competitive intelligence in the API market? A: Companies can leverage competitive intelligence by monitoring competitor pipelines, analyzing patent landscapes, tracking regulatory strategies, and using social media monitoring.

Sources cited: [1] https://www.mordorintelligence.com/industry-reports/united-states-active-pharmaceutical-ingredients-market/companies [2] https://www.fortunebusinessinsights.com/active-pharmaceutical-ingredient-api-market-102656 [4] https://visualping.io/blog/competitive-intelligence-in-pharma [5] https://www.globenewswire.com/news-release/2024/11/19/2983486/28124/en/Active-Pharmaceutical-Ingredients-API-Global-Market-Research-2024-Biologics-and-Personalized-Therapies-Drive-Growth-in-Large-Molecule-API-Segment-Through-2030.html [8] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/ [10] https://www.fortunebusinessinsights.com/small-molecule-api-market-107457