Stevens J Company Profile

What is the competitive landscape for STEVENS J

STEVENS J has thirteen approved drugs.

There is one US patent protecting STEVENS J drugs.

Summary for Stevens J

US Patents:	1
Tradenames:	12
Ingredients:	11
NDAs:	13

Drugs and US Patents for Stevens J

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210-009	Aug 21, 2000	AB1,AB2,AB3	RX	Yes	No
Stevens J	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	210738-003	Oct 31, 2018		DISCN	No	No
Stevens J	DIGOXIN	digoxin	TABLET;ORAL	076268-002	Jul 26, 2002	AB	RX	No	No
Stevens J	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	aspirin; caffeine; orphenadrine citrate	TABLET;ORAL	074988-002	Apr 30, 1999		DISCN	No	No
Stevens J	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	204364-002	Dec 2, 2021		DISCN	No	No
Stevens J	DEFERASIROX	deferasirox	TABLET;ORAL	210727-003	Jun 15, 2020		DISCN	No	No
Stevens J	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	210738-001	Oct 31, 2018		DISCN	No	No

International Patents for Stevens J Drugs

Country	Patent Number	Estimated Expiration
Serbia	54524
Poland	2683361
Denmark	2683361
Slovenia	2683361
Croatia	P20151421
European Patent Office	2683361
Spain	2559818

Supplementary Protection Certificates for Stevens J Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	05C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
0592438	02C0013	France		PRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
0914118	06C0049	France		PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
0914118	PA2007001,C0914118	Lithuania		PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
1203761	C01203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
0914118	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
1203761	SPC/GB05/031	United Kingdom		PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410

Similar Applicant Names

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

• Stevens J

Stevens J Competitive Landscape Analysis: Market Position, Patent/Exclusivity Strength, and Generic or Biosimilar Entry Risks

Last updated: July 25, 2026

Stevens J is not uniquely identifiable from the provided topic alone. No drug name, active ingredient, FDA application number, NDC, ATC/therapeutic class, manufacturer, or jurisdictional scope is specified, and the patent estate cannot be mapped without that identifier. Under these constraints, a complete and accurate competitive landscape cannot be produced.

What is “Stevens J” and which FDA-listed drug does it correspond to?

No mapping from “Stevens J” to a specific marketed pharmaceutical product can be established from the input provided.

Which active ingredient and dosage forms define Stevens J?

No product attributes (active ingredient, strength, route, formulation type) are provided.

What are the key manufacturer and labeler entities tied to Stevens J?

No labeler or marketing authorization holder is provided.

Which patents protect Stevens J, and how strong is the patent estate?

No patent-holder or reference-listed drug (RLD) can be identified, so no Orange Book-style patent coverage, expiration dates, or enforceable claim scope can be compiled.

How many patents cover Stevens J across composition, formulation, and method-of-use?

Not determinable without an FDA RLD/RxNorm/Orange Book listing.

What are the latest scheduled expiration dates for exclusivity and patents?

Not determinable.

What litigation affects Stevens J’s enforceability?

Not determinable.

When does Stevens J lose exclusivity, and what are the Paragraph IV or biosimilar risks?

No FDA pathway or exclusivity anchors (NCE, 5-year, 3-year new clinical investigations, 7-year orphan, patent-term adjustments, data exclusivity, pediatric exclusivity) can be tied to a specific drug.

What is the FDA Orange Book status of Stevens J?

Not determinable.

What is the earliest legal generic entry date for Stevens J?

Not determinable.

What is the biosimilar or interchangeable product risk for Stevens J?

Not determinable.

What formulations are protected for Stevens J, and what generic entry risks exist by dosage form?

No formulation details are available, so formulation-specific barriers cannot be assessed.

Are capsule/tablet/solution/suspension formats covered by separate patents?

Not determinable.

Does Stevens J have drug-device combination protections that block 505(b)(2) or ANDA work?

Not determinable.

Which companies are challenging Stevens J with generics or biosimilars?

No challengers, patent certifications, or FDA submissions (ANDA/505(b)(2)/BLA) are provided.

Which Paragraph IV filers exist for Stevens J?

Not determinable.

What settlements have been announced for Stevens J?

Not determinable.

How does Stevens J compare with competing products in the same therapeutic category?

No therapeutic category or comparator set can be built without an identified active ingredient and indication.

What is the competitive set and market positioning for Stevens J?

Not determinable.

How do pricing and market share dynamics map to Stevens J’s differentiation?

Not determinable.

What manufacturing/IP barriers could delay generic or biosimilar launch for Stevens J?

No facility, process, polymorph/crystal form, scale-up, or process patent identifiers are available.

Are there process or method-of-manufacture patents tied to Stevens J?

Not determinable.

Does Stevens J have REMS or other regulatory constraints that affect launch?

Not determinable.

What is the commercial revenue exposure tied to Stevens J, and how does that change with upcoming expirations?

No revenue figures, payer coverage, volume, or forecast inputs are provided, and no exclusivity timeline is anchorable without a specific product.

What revenue is at risk over the next 3 to 7 years for Stevens J?

Not determinable.

What scenarios drive downside or upside for investors/licensors?

Not determinable.

Key Takeaways

• “Stevens J” cannot be matched to a specific FDA-listed pharmaceutical product from the provided input.
• Without drug identity (active ingredient, RLD, FDA application, dosage form, labeler), the patent estate, Orange Book status, exclusivity loss dates, and competitive entry risks cannot be compiled accurately.
• A complete competitive landscape analysis requires a determinable product reference, which is not present in the prompt.

FAQs

1. What is the correct FDA reference product (RLD) identifier for “Stevens J”?
2. How do Orange Book patent certifications for “Stevens J” determine Paragraph IV timing?
3. What is the earliest legal generic launch date if “Stevens J” is an NCE with multiple Orange Book patents?
4. Which process or formulation patents most frequently block generics for branded oral solid Stevens products?
5. How do REMS and FDA pathway differences affect biosimilar/505(b)(2) launch timelines for Stevens-branded drugs?

References

No sources are cited because no drug identity is provided, preventing accurate patent, exclusivity, or regulatory mapping.