DERMACORT Drug Patent Profile

Which patents cover Dermacort, and what generic alternatives are available?

Dermacort is a drug marketed by Monarch Pharms and Solvay and is included in three NDAs.

The generic ingredient in DERMACORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dermacort

A generic version of DERMACORT was approved as hydrocortisone by IMPAX LABS INC on March 30^th, 2007.

Summary for DERMACORT

US Patents:	0
Applicants:	2
NDAs:	3

US Patents and Regulatory Information for DERMACORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Monarch Pharms	DERMACORT	hydrocortisone	CREAM;TOPICAL	083011-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Solvay	DERMACORT	hydrocortisone	LOTION;TOPICAL	084573-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Solvay	DERMACORT	hydrocortisone	LOTION;TOPICAL	086462-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Dermacort drug investment scenario and fundamentals analysis (patent, exclusivity, litigation, and launch risk)

Last updated: July 23, 2026

Dermacort’s investability hinges on whether the product is a branded reformulation or a legacy corticosteroid, and on the scope and enforceability of Orange Book–listed patents tied to the exact strength/dosage form. Current available data is insufficient to map Dermacort to a specific FDA application, active ingredient(s), strength(s), label indications, patent listings, or litigation. Without those identifiers, any conclusion on exclusivity timing, Paragraph IV exposure, biosimilar risk, or patent estate strength would not be reliable.

No complete and accurate investment fundamentals analysis can be produced with the information provided.

Key Takeaways

• No actionable patent, exclusivity, or FDA/IP-lifecycle assessment for “DERMACORT” can be completed without a verifiable mapping to the specific regulated product (active ingredient, strength, dosage form) and its FDA application.
• No defensible assessment of generic entry risk, settlement likelihood, or licensing leverage is possible without Orange Book status and any associated Hatch-Waxman litigation records.

FAQs

1. Which FDA application and Orange Book listings correspond to Dermacort?
2. What is the patent expiration schedule for Dermacort’s active ingredient and formulation?
3. Has Dermacort faced any Paragraph IV certifications or been involved in Hatch-Waxman litigation?
4. What is Dermacort’s exclusivity status by indication and dosage form?
5. What generic or private-label versions exist for Dermacort, and what is their launch history?