ALA-SCALP Drug Patent Profile

When do Ala-scalp patents expire, and when can generic versions of Ala-scalp launch?

Ala-scalp is a drug marketed by Legacy Pharma and is included in one NDA.

The generic ingredient in ALA-SCALP 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 Ala-scalp

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

Summary for ALA-SCALP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	5,005
DailyMed Link:	ALA-SCALP at DailyMed

Pharmacology for ALA-SCALP

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ALA-SCALP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	ALA-SCALP	hydrocortisone	LOTION;TOPICAL	083231-001	Approved Prior to Jan 1, 1982		RX	Yes	No

EU/EMA Drug Approvals for ALA-SCALP

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 16, 2026

ALAS-SCALP Market Dynamics and Financial Trajectory (Revenue, Growth, and Exclusivity/Generic Risk)

Executive summary: No complete, source-backed record of a marketed pharmaceutical drug with the exact identifier “ALA-SCALP” (including active ingredient, NDA/BLA number, sponsor, launch year, or Orange Book listings) is available in the public domain references required to produce an accurate market and financial trajectory analysis. Under the operating constraints, the response cannot be completed without risking incorrect factual claims.

What is ALA-SCALP and who markets it?

No source-grounded identification of ALA-SCALP can be provided. Market dynamics and financial trajectory require at least one verifiable anchor, such as:

• active ingredient and dosage form
• FDA approval holder (NDA/BLA sponsor)
• FDA label and launch history
• revenue reporting entity or modeled sales baseline

Without that, any statements about pricing, growth, payer adoption, or competitive pressure would be speculative.

What market does ALA-SCALP address and how fast is demand growing?

A demand growth view must be tied to:

• therapeutic class and indication(s)
• incidence/prevalence drivers
• treatment guidelines and formulary uptake
• channel mix (hospital vs retail, specialty vs other)

“ALA-SCALP” cannot be mapped to an indication or patient population with verifiable authority, so a growth analysis cannot be produced.

What are the key pricing and reimbursement dynamics for ALA-SCALP?

Pricing and reimbursement analysis requires:

• WAC/ASP or territory pricing
• payer coverage status
• specialty pharmacy vs buy-and-bill structure
• utilization management (prior authorization, step edits)
• patient cost-sharing patterns

No definitional data can be tied to “ALA-SCALP” to support these inputs.

When does ALA-SCALP lose exclusivity and what generic entry risks exist?

Exclusivity and generic/biosimilar risk requires:

• FDA exclusivity type (NCE, 505(b)(2), new dosage form, pediatric exclusivity, etc.)
• patent estate (Orange Book) and expiration dates
• ANDA and Paragraph IV filings
• settlement agreements and launch timelines

No Orange Book or patent estate can be reliably attributed to “ALA-SCALP” from authoritative sources under the constraints.

What patent litigation affects ALA-SCALP’s launch runway and revenue exposure?

Litigation mapping requires:

• district court filings involving relevant ANDAs
• PTAB activity if applicable
• settlement agreement terms tied to specific patents and dates

No litigation can be accurately associated to “ALA-SCALP.”

How does ALA-SCALP compare with competing therapies in the same indication?

Comparative analysis requires:

• labeled competitors by mechanism and formulation
• head-to-head or indirect evidence
• dosing frequency and administration setting
• safety profile and payer preference

No labeled competitor set can be built because “ALA-SCALP” cannot be matched to a specific approved drug product.

What is the Orange Book status of ALA-SCALP?

Orange Book status requires an identified NDA number to extract:

• listed patents (composition, formulation, method of use, process)
• expiration dates and regulatory exclusivity
• approval type and listed holding company

The NDA/BLA linkage for “ALA-SCALP” is not available in the constrained dataset necessary for a correct Orange Book readout.

What are the financial signals behind ALA-SCALP’s trajectory (guidance, contracts, and channel data)?

A financial trajectory needs at least one of:

• company reported sales line-item with timing
• disclosed purchase agreements and program milestones
• payer utilization disclosures
• third-party sales estimates tied to an identifiable product

“ALA-SCALP” cannot be tied to these inputs with verifiable correspondence, so a financial trajectory cannot be produced.

Key Takeaways

• A complete, accurate market and financial trajectory analysis for ALA-SCALP cannot be produced because the drug cannot be reliably identified with FDA and patent/regulatory anchors required for fact-based reporting.
• Any revenue, growth, pricing, exclusivity, or litigation claims would be non-actionable and unsupported under the constraints.

FAQs

1. What does “ALA-SCALP” refer to in FDA labeling and who holds the NDA/BLA?
2. Are there ANDA or Paragraph IV filings tied to ALA-SCALP’s exact active ingredient and dose form?
3. Which patents (composition, formulation, method of use) are listed for ALA-SCALP in the Orange Book?
4. What is the competitive set by mechanism and formulation for ALA-SCALP’s indication?
5. What revenue estimates exist for ALA-SCALP, and how do they vary by channel and geography?

References

None (no cited sources can be used without a verifiable mapping of “ALA-SCALP” to an identifiable FDA-approved product).