Handa Therap Company Profile

What is the competitive landscape for HANDA THERAP

HANDA THERAP has one approved drug.

There are three US patents protecting HANDA THERAP drugs.

There are six patent family members on HANDA THERAP drugs in six countries and eleven supplementary protection certificates in ten countries.

Summary for Handa Therap

International Patents:	6
US Patents:	3
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Handa Therap

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No	11,202,778
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No	11,202,778
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	11,324,745

International Patents for Handa Therap Drugs

Country	Patent Number	Estimated Expiration
Australia	2021210974
Canada	3168667
European Patent Office	4093379
Israel	294928
Japan	2023513444
World Intellectual Property Organization (WIPO)	2021150981

Supplementary Protection Certificates for Handa Therap Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	132013902119320	Italy		PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120
1169038	1390004-8	Sweden		PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
1169038	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120

Similar Applicant Names

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

• Handa Therap

Handa Therap Market Analysis and Financial Projection

Here is a comprehensive analysis of Handa Therapeutics' competitive position in the pharmaceutical industry:

Company Overview

Handa Therapeutics is a specialty pharmaceutical company focused on developing high-quality medications that address significant unmet medical needs, particularly in oncology and neurology. Key facts about the company include:

• Headquartered in the San Francisco Bay area
• Subsidiary of Handa Pharmaceuticals, Inc. (Taiwan-based parent company)
• Leadership team has a track record of building successful pharmaceutical businesses
• Recently acquired FDA-approved leukemia drug PHYRAGO (dasatinib) tablets

Market Position

Handa Therapeutics is positioning itself as an innovative player in the specialty pharmaceutical space, with a focus on improved formulations of existing drugs. Some key aspects of their market position:

• Targeting niche areas with high unmet needs, particularly in oncology
• Leveraging 505(b)(2) regulatory pathway to bring enhanced versions of approved drugs to market faster
• Building a portfolio of both branded and generic products
• Still a relatively small player compared to big pharma, but growing through strategic acquisitions

Key Strengths

1. Focus on innovation: Handa invests heavily in R&D to develop novel formulations that improve upon existing therapies. This allows them to differentiate in crowded markets.

2. Experienced leadership: The management team has a proven track record in pharmaceutical development and commercialization.

3. Strategic approach: Handa is selective in choosing development projects, focusing on areas with clear market opportunities.

4. Efficient development model: By leveraging the 505(b)(2) pathway, Handa can bring products to market faster and at lower cost than traditional drug development.

5. Growing product portfolio: Recent acquisition of PHYRAGO strengthens their oncology pipeline.

Strategic Insights

1. Niche focus strategy: By targeting specific therapeutic areas and patient populations, Handa can compete effectively against larger pharma companies.

2. Emphasis on improved formulations: Developing enhanced versions of existing drugs allows Handa to enter established markets with differentiated products.

3. Balanced portfolio approach: Mix of branded and generic products provides diversified revenue streams.

4. Strategic partnerships: Handa is actively seeking commercialization partners to maximize the potential of its products.

5. Global expansion: While currently focused on the US market, Handa has potential for international growth through its parent company's connections.

Competitive Landscape

Handa faces competition from both large pharmaceutical companies and other specialty pharma players. Key competitors include:

• Major oncology players: Novartis, Bristol Myers Squibb, Pfizer
• Other specialty pharma companies: Amneal Pharmaceuticals, Hikma Pharmaceuticals
• Generic manufacturers entering the specialty space

SWOT Analysis

Strengths:

• Innovative R&D capabilities
• Experienced management team
• Efficient development model
• Growing product portfolio

Weaknesses:

• Limited commercial infrastructure
• Smaller scale compared to big pharma
• Reliance on partners for commercialization

Opportunities:

• Expanding into additional therapeutic areas
• International market expansion
• Further strategic acquisitions

Threats:

• Intense competition in oncology space
• Regulatory challenges
• Pricing pressures in pharmaceutical industry

Future Outlook

Handa Therapeutics is well-positioned for growth in the specialty pharmaceutical market. Their focus on innovation, strategic approach to product development, and recent acquisitions provide a solid foundation. Key factors for future success will include:

1. Successful commercialization of PHYRAGO and other pipeline products
2. Continued innovation in formulation development
3. Establishing strong partnerships for marketing and distribution
4. Expanding into additional therapeutic areas beyond oncology
5. Navigating the complex regulatory and pricing environment in pharmaceuticals

By leveraging its strengths and pursuing a focused strategy, Handa has the potential to become a significant player in the specialty pharmaceutical space, particularly in oncology and other niche therapeutic areas.

Sources cited: 1, 5, 9, 13, 14, 17