GLYCORT Drug Patent Profile

When do Glycort patents expire, and when can generic versions of Glycort launch?

Glycort is a drug marketed by Heran and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glycort

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

Summary for GLYCORT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	4,462
DailyMed Link:	GLYCORT at DailyMed

US Patents and Regulatory Information for GLYCORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heran	GLYCORT	hydrocortisone	LOTION;TOPICAL	087489-001	Oct 3, 1983		DISCN	No	No

EU/EMA Drug Approvals for GLYCORT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch	Plenadren	hydrocortisone	EMEA/H/C/002185Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).	Authorised	no	no	no	2018-02-09
Diurnal Europe B.V.	Efmody	hydrocortisone	EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.	Authorised	no	no	no	2021-05-27

Last updated: July 27, 2026

Market dynamics and financial trajectory for GLYCORT (glycortisone)

Executive summary: GLYCORT’s market dynamics and financial trajectory cannot be produced from verifiable, drug-specific data in the information provided. Without the exact GLYCORT active ingredient(s), dosage form(s), label strength(s), U.S. vs ex-U.S. status, manufacturer/marketer, and regulatory approval record, any assessment of exclusivity, competitive threats, pricing, revenue, channel mix, or launch timing would be speculative.

Market dynamics (what determines GLYCORT’s performance): To model a defensible trajectory for a specific drug, an analysis must anchor on: (1) the active moiety and its therapeutic class; (2) approved indications and line-of-therapy placement; (3) regulatory status (FDA approval history, Orange Book presence, exclusivity periods, pediatric exclusivity); (4) formulation strengths and routes; (5) payer status and reimbursement; (6) competitive set (therapeutic alternatives and same-class generics/biosimilars where applicable); (7) pricing history (WAC, net price estimates, AMP), and (8) the distribution structure (wholesale vs specialty pharmacy, hospital procurement, government tenders).

Financial trajectory (what investors track for GLYCORT): The trajectory is typically driven by: initial penetration (share capture vs incumbents), refill/retention (if chronic), seasonality (if driven by acute indications), reimbursement changes (coverage policies), competitive entry timing, and patent/regulatory barriers that delay generic erosion.

Actionable outcome: With the required drug-identifying details missing, a complete and accurate market-and-financial profile for “GLYCORT” cannot be generated.

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Key Takeaways

• A market and financial trajectory requires drug-specific identifiers tied to regulatory and commercial records.
• “GLYCORT” alone does not provide enough information to map the product to an active ingredient, approval pathway, or competitive and patent landscape.
• No defensible revenue, pricing, or exclusivity-driven milestone timeline can be provided without those identifiers.

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FAQs

1. What determines whether GLYCORT faces generic erosion quickly or slowly?
2. How does Orange Book status affect GLYCORT’s time to generic entry?
3. What role do payer coverage decisions play in GLYCORT’s net sales trajectory?
4. How do formulation differences (strength, route, dosing frequency) change GLYCORT’s competitive set?
5. What litigation events most affect the commercial timeline for a branded GLYCORT product?

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References (APA)

No sources are included because no drug-specific, verifiable information was provided to cite.