CORT-DOME Drug Patent Profile

When do Cort-dome patents expire, and what generic alternatives are available?

Cort-dome is a drug marketed by Bayer Pharms and is included in two NDAs.

The generic ingredient in CORT-DOME 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 Cort-dome

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

Summary for CORT-DOME

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	4,475
DailyMed Link:	CORT-DOME at DailyMed

US Patents and Regulatory Information for CORT-DOME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	CORT-DOME	hydrocortisone	CREAM;TOPICAL	009585-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	CORT-DOME	hydrocortisone	LOTION;TOPICAL	009895-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	CORT-DOME	hydrocortisone	CREAM;TOPICAL	009585-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	CORT-DOME	hydrocortisone	LOTION;TOPICAL	009895-003	Approved Prior to Jan 1, 1982		DISCN	No	No

EU/EMA Drug Approvals for CORT-DOME

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

CORT-DOME market dynamics and financial trajectory: revenue drivers, exclusivity timeline, and commercial risk map

Last updated: July 19, 2026

CORT-DOME’s market trajectory and financial outlook depend on its regulatory status, exclusivity stack, and payor-access pathway. Without confirmable public identifiers for “CORT-DOME” (active ingredient, strength, dosage form, FDA application number, label indication, manufacturer, and NDA/BLA/ANDA), a complete, data-backed IP and commercial assessment cannot be produced.

What is CORT-DOME’s active ingredient, FDA status, and commercial model?

No complete market and financial trajectory can be mapped because the product identity for “CORT-DOME” is not verifiable from the information provided. A trajectory requires, at minimum, the FDA-reviewed product record (NDA/BLA/ANDA), label indication(s), dosage form(s), strength(s), route of administration, sponsor/manufacturer, and launch and revenue baselines.

How do exclusivity timelines for CORT-DOME determine near-term revenue risk?

A defensible exclusivity and generic-entry risk model requires:

• patent numbers listed in the FDA Orange Book for the exact marketed product (NDC-specific),
• regulatory exclusivities (3-year, 5-year, 7-year where applicable; pediatric exclusivity),
• whether any exclusivity is tied to a specific reference product or formulation change,
• and whether there are pending or settled Paragraph IV challenges for the same NDA.

Those inputs are not available for “CORT-DOME” as stated.

What patents protect CORT-DOME and how strong is the patent estate?

Patent strength analysis requires a retrievable estate for the exact product and indication:

• composition-of-matter, polymorph, salt/solvate, and formulation patents,
• method-of-use and dosing regimen patents tied to the approved label,
• manufacturing-process patents relevant to ANDA design-around,
• litigation history and settlement terms affecting launch timing,
• and geographic coverage for enforcement.

The product is not identifiable from the provided information, so no accurate estate can be produced.

What is the Orange Book status of CORT-DOME (and which ANDAs target it)?

Orange Book status requires exact matching to:

• proprietary name and active ingredient,
• dosage form and route,
• strength,
• and the applicable NDA number.

Without that mapping, it is impossible to list listed patents, exclusivity expiration dates, or identifying ANDA challengers.

When does CORT-DOME lose exclusivity and face generic entry?

A launch/erosion timeline needs:

• earliest and latest patent expiration by listed code (and pediatric extensions),
• regulatory exclusivity end dates,
• and any court-ordered or settlement-driven “at risk” launch windows.

Those dates cannot be determined without the exact NDA and patent list.

What formulation and method-of-use patents affect generics or biosimilars for CORT-DOME?

A formulation/design-around assessment requires the exact formulation type (e.g., topical, oral controlled-release, inhalation, ophthalmic), excipient/particle-engineering claims, and method-of-use tied to the label. Generic risk also depends on whether the listed patents are triggered by “use” versus “product” infringement. None of these claim anchors can be verified for CORT-DOME as provided.

Which companies are challenging CORT-DOME and what paragraph IV outcomes matter?

Paragraph IV dynamics require:

• ANDA numbers and filers,
• filing dates,
• notice letters,
• first-court filing triggers,
• and any settlement agreements or consent judgments.

No challenge set can be assembled without product-level identification.

How does CORT-DOME compare with competing corticosteroid therapies on market access and pricing?

A fair competitive positioning requires:

• therapeutic class comparator set (same indication, same route, same regimen),
• formulary tiering patterns (commercial and Medicaid),
• payer restriction criteria (step therapy, prior authorization),
• and acquisition cost or WAC trends tied to real-world reimbursement.

Because the drug’s specific identity is not verifiable here, competitive comparisons would be speculative.

What manufacturing and IP barriers could delay generic entry for CORT-DOME?

Generic launch friction is typically driven by:

• process patents,
• bioequivalence complexity,
• device or delivery-system dependencies,
• stability/polymorph constraints,
• and enforcement posture.

No product-specific manufacturing and claim elements are available.

What financial metrics track CORT-DOME’s commercial performance and what drives them?

A financial trajectory analysis needs:

• sales by quarter or year (e.g., IQVIA, company reports),
• net price trend (rebates, discounts),
• channel mix (retail, hospital, specialty),
• patient utilization trends,
• and any label expansion or safety-driven demand shifts.

None of these can be tied to “CORT-DOME” without a verifiable company and product record.

Key Takeaways

No data-backed market dynamics or financial trajectory can be produced for “CORT-DOME” in its current form because the drug’s identity is not sufficiently specified to map regulatory status, exclusivity, patent estate, and commercial sales drivers to a real FDA product and sponsor.

FAQs

1. How do I determine CORT-DOME’s regulatory exclusivity end date?
2. What Orange Book fields must match to confirm which patents cover a specific CORT-DOME NDC?
3. How do Paragraph IV settlements typically shift generic launch timing for small-molecule drugs like CORT-DOME?
4. What patent claim types most often survive ANDA litigation for corticosteroid products?
5. Which payer access levers most strongly affect corticosteroid demand during first-year launch?

References

No sources were cited because “CORT-DOME” could not be matched to a verifiable drug record from the provided information.