Eton Company Profile

What is the competitive landscape for ETON

ETON has seven approved drugs.

There are nine US patents protecting ETON drugs.

Summary for Eton

US Patents:	9
Tradenames:	7
Ingredients:	6
NDAs:	7
Patent Litigation for Eton:	See patent lawsuits for Eton
PTAB Cases with Eton as petitioner:	See PTAB cases with Eton as petitioner

Drugs and US Patents for Eton

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-001	Sep 29, 2020		RX	Yes	No	9,649,280		Y
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-001	Sep 29, 2020		RX	Yes	No	9,717,740
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-004	Sep 29, 2020		RX	Yes	Yes	9,649,280		Y
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-003	Sep 29, 2020		RX	Yes	No	9,717,740
Eton	GALZIN	zinc acetate	CAPSULE;ORAL	020458-002	Jan 28, 1997		RX	Yes	Yes
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201-002	May 25, 2023	AB	RX	No	No
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-002	Sep 29, 2020		RX	Yes	No	9,649,280		Y

International Patents for Eton Drugs

Country	Patent Number	Estimated Expiration
Portugal	2780003
Spain	2368299
Hong Kong	1148940
Hong Kong	1194005
Hungary	E048445
Slovenia	2187878
South Korea	101562627

Supplementary Protection Certificates for Eton Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3225249	2019C/520	Belgium		PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0591275	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
2712622	201740002	Slovenia		PRODUCT NAME: DESMOPRESSINE OR ITS ACETATE SALT; NATIONAL AUTHORISATION NUMBER: H/16/02212/001-008; DATE OF NATIONAL AUTHORISATION: 20160818; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: BE497271,BE497280; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20160504; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: BE
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
2712622	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018

Similar Applicant Names

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

• Eton

Eton (brand Eton?) competitive landscape analysis: market position, IP strength, and generic/biosimilar risks

Last updated: July 3, 2026

No complete, verifiable target profile can be produced from the provided prompt. The name “Eton” does not uniquely identify a single FDA-regulated drug product or active ingredient, and a competitive landscape analysis requires unambiguous mapping to the specific marketed drug (active ingredient, dosage form, NDA/BLA, and Orange Book listings).

Key Takeaways

• The prompt does not specify the active ingredient, dosage form, NDA/BLA number, applicant/labeler, or geographic scope for “Eton.”
• Without that mapping, an accurate competitive landscape cannot be constructed using patent estate data, Paragraph IV events, FDA exclusivity, or Orange Book status.

FAQs

1. What is required to analyze Eton’s patent estate and exclusivity timeline?
2. How does Orange Book listing determine generic entry risk for a branded drug?
3. What patent types typically block generic entry for small-molecule versus biologics?
4. How do Paragraph IV challenges affect FDA review timelines and market exclusivity?
5. What data fields are necessary to quantify revenue exposure by competitor class (authorized generics, 505(b)(2), biosimilars)?