Nivagen Pharms Inc Company Profile

What is the competitive landscape for NIVAGEN PHARMS INC

NIVAGEN PHARMS INC has nine approved drugs.

Summary for Nivagen Pharms Inc

US Patents:	0
Tradenames:	9
Ingredients:	9
NDAs:	9

Drugs and US Patents for Nivagen Pharms Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nivagen Pharms Inc	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	213328-002	Nov 23, 2021		DISCN	No	No
Nivagen Pharms Inc	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	212117-001	Dec 7, 2020	AP	RX	No	No
Nivagen Pharms Inc	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	213071-003	Apr 30, 2024	AP	RX	No	No
Nivagen Pharms Inc	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	215635-001	Jun 28, 2024	AP	RX	No	No
Nivagen Pharms Inc	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	211969-001	Jun 21, 2021	AB	RX	No	No
Nivagen Pharms Inc	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	213071-002	Oct 19, 2023	AP	RX	No	No

Similar Applicant Names

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

• Nivagen Pharms Inc

Last updated: July 20, 2026

Nivagen Pharms Inc Competitive Landscape Analysis: Market Position, Patent Strength, and Generic/Biosimilar Risk

Nivagen Pharms Inc’s competitive landscape is not assessable from the information available in this session. A patent- and exclusivity-driven market position requires identifying the company’s marketed drugs, FDA registrations, Orange Book listings, and any active patent estates or litigation. Without those inputs, a complete, accurate analysis cannot be produced.

What drugs does Nivagen Pharms Inc sell in the US, and which therapeutic areas drive revenue?

What is the Orange Book status of Nivagen Pharms Inc products (listed patents, exclusivity, and approval dates)?

What patents protect Nivagen Pharms Inc products, and when do key patents expire?

How strong is the patent estate for each Nivagen product (composition, formulation, method-of-use, manufacturing)?

What generic entry risks exist for Nivagen products (Paragraph IV patterns and typical claim scopes)?

When does FDA exclusivity end for Nivagen products (5-year, 7-year, 3-year new clinical investigations)?

What patent litigation affects Nivagen Pharms Inc (ANDA 505(b)(2) disputes, settlements, injunction outcomes)?

Which companies are challenging Nivagen via Paragraph IV or 505(b)(2) pathways?

What formulations are protected by Nivagen Pharms Inc patents (extended-release, taste-masked, injectables, ophthalmics)?

How does Nivagen Pharms Inc compare with peers in CDMO/launch strategy and IP defensibility?

How many patents cover Nivagen products, and how does that compare with competitors’ estates?

What manufacturing and IP barriers could slow generic or biosimilar launch for Nivagen products?

What is the competitive outlook for Nivagen Pharms Inc over the next 24 months (launch threats and shelf-risk windows)?

Key Takeaways

FAQs

1. Which FDA-reviewed products have Nivagen’s exclusivity running, and what are the end dates?
2. How many Orange Book patents typically remain at risk for Nivagen products by year of filing?
3. Which claim types (composition vs method-of-use vs formulation) drive the strongest injunction leverage for Nivagen?
4. What settlement patterns have historically governed generic entry against Nivagen’s listed drugs?
5. Which non-US jurisdictions most influence Nivagen’s market defense strategy for product lifecycles?

References

1. (No cited sources available.)