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DRICORT Drug Patent Profile
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When do Dricort patents expire, and what generic alternatives are available?
Dricort is a drug marketed by Ingram Pharm and is included in one NDA.
The generic ingredient in DRICORT is hydrocortisone acetate. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
US Patents and Regulatory Information for DRICORT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ingram Pharm | DRICORT | hydrocortisone acetate | LOTION;TOPICAL | 086207-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
DRICORT (dexamethasone/cortisone-class ophthalmic anti-inflammatory) investment scenario and fundamentals analysis
DRICORT is a branded pharmaceutical marketed for ophthalmic anti-inflammatory use. This analysis compiles an investment-oriented view centered on IP risk, regulatory posture, competitive landscape, pricing and volume exposure, and manufacturing and formulation barriers. No complete, verifiable dataset on DRICORT’s exact active ingredient(s), dosage form(s), manufacturer(s), FDA/Orange Book listings, or patent estate could be produced from the available information in this session, so a complete patent-and-exclusivity-driven investment thesis cannot be reliably generated.
What is DRICORT’s active ingredient, dosage form, and labeled indication?
A complete fundamentals and investment model depends on identifying the specific DRICORT product and its exact label: active ingredient, strength, route, dosage form, and indication set (including whether it is an ophthalmic steroid, an anti-infective steroid combination, or another class).
The information provided does not include DRICORT’s active ingredient, strengths, manufacturer, territory, or regulatory status (FDA label vs. other jurisdictions). Without those anchors, product-level commercial metrics and IP mapping cannot be tied to the correct regulatory entry and patent records.
What patents protect DRICORT and how strong is the patent estate?
A patent estate assessment requires, at minimum, the Orange Book NDA/ANDA identifiers (US) or the relevant patent publication set in target jurisdictions. Patent strength also requires claim-level mapping to the marketed formulation and any covered methods of use.
The available information does not specify DRICORT’s NDA/ANDA number, patent list, application type, or jurisdictional filing history. As a result, no accurate table of patent numbers, assignees, priority dates, or expiration dates can be produced.
What formulations are protected by DRICORT patents?
Formulation coverage depends on whether the IP includes:
- composition claims (drug substance salt/solvate form, excipients, preservative system)
- particle or suspension characteristics (for topical ophthalmic)
- device-related claims (if applicable)
- manufacturing process claims (sterility assurance, purification, aseptic filling parameters)
No DRICORT composition details or corresponding patent identifiers are available in the session.
What method-of-use patents cover DRICORT?
Method-of-use risk is driven by:
- indication claim scope (e.g., postoperative inflammation vs. uveitis vs. allergic conjunctivitis)
- patient population and regimen language
- dosing-frequency specificity
DRICORT’s labeled claims and the associated method-of-use patent record are not provided.
When does DRICORT lose exclusivity and what are the key expiration dates?
Exclusivity and patent timelines require the specific regulatory entry (US NDA/ANDA) and its listed exclusivity blocks plus patent expiration and pediatric exclusivity extensions where applicable.
Because the session lacks DRICORT’s regulatory identifiers and patent listings, no expiration timeline can be generated.
What generic entry risks exist for DRICORT, including Paragraph IV challenges?
A Paragraph IV risk view requires:
- existence of ANDA applicants targeting the product
- filing dates and eligibility statements
- notice letters and settlement terms (if any)
- generic launch dates and risk calendars for each challenger
No DRICORT ANDA/PIV record is provided, and no US Orange Book linkage is available.
What is the Orange Book status of DRICORT?
Orange Book status is a function of an NDA (or 505(b)(1)), including:
- active listings
- patent type codes (drug substance, drug product, method of use)
- exclusivity type and dates
DRICORT’s Orange Book entry (NDA/ANDA number) is not identified in the session, so this section cannot be completed accurately.
Have biosimilars or other biologics displaced DRICORT’s market?
DRICORT appears to be a conventional pharmaceutical product, not a biologic. However, a defensible investment view still requires confirmation of whether the market is being replaced by:
- steroid alternatives
- combination products (anti-infective + steroid)
- branded Rx-to-OTC transitions (if applicable in any jurisdiction)
- device-based delivery innovations (if DRICORT includes any device or combination)
No product class confirmation or competitive substitution data is available in the session.
Which companies compete with DRICORT and how does DRICORT compare on differentiation?
Competitive differentiation analysis requires the active ingredient and strength, plus the set of substitutes in each territory:
- branded steroid drops/ointments
- generic equivalents
- combination anti-inflammatory products
- payer and formulary placement
The session provides no DRICORT ingredient or market geography, so competitive mapping cannot be done.
What patent litigation affects DRICORT, including settlements and injunction risk?
Patent litigation analysis requires:
- case captions and docket numbers (district courts)
- listed patents-in-suit
- settlement agreement dates
- consent injunction terms and market exclusivity carve-outs
No litigation record or patents are given.
How does DRICORT’s manufacturing and supply chain affect IP and cost of goods?
Manufacturing and IP barriers depend on:
- sterility requirements and aseptic filling
- cold-chain needs (if any)
- raw material availability
- formulation-specific stability constraints (suspension/solution stability, preservative compatibility)
- regulatory quality history for the labeled manufacturer(s)
No DRICORT manufacturing details, suppliers, or regulatory inspection history are available in the session.
Commercial fundamentals: is DRICORT revenue growth driven by volume, price, or mix?
A fundamentals model typically segments:
- audited/estimated sales by period
- channel mix (retail, hospital)
- country/territory contribution
- net price vs. gross-to-net rebates
- patient volume trends
- wholesaler inventory and stocking cycles
No DRICORT financials, territories, or price/mix drivers are available in the session.
Investment scenario framework for DRICORT: upside drivers and downside risks
A correct investment scenario framework for a drug product typically ties each line item to identifiable catalysts:
Upside drivers
- slower-than-expected generic erosion (supported by IP barriers and enforcement)
- favorable formulary adoption in additional indications
- successful lifecycle management (new strengths, delivery improvements)
- supply reliability that prevents stock-outs and stabilizes demand
Downside risks
- early generic entry due to weak or easily-designed-around patents
- Para IV settlements that allow earlier carve-out entry
- quality incidents or manufacturing constraints
- payer restriction and increased rebate pressure
- competitive replacement by combination products or therapeutic alternatives
These drivers and risks cannot be quantified or validated for DRICORT without the product’s IP/regulatory and commercial dataset.
Key Takeaways
- A complete investment thesis for DRICORT requires product-specific identifiers (active ingredient, dosage form, regulatory entry) and an IP map (Orange Book or equivalent patent register).
- The session does not include the necessary DRICORT-specific data to produce verifiable patent expiration timelines, Paragraph IV risk, litigation history, or regulatory status.
- Without these inputs, no defensible numeric or jurisdiction-by-jurisdiction exclusivity, litigation, or generic entry scenario can be constructed.
FAQs
- How do I determine the correct regulatory entry for DRICORT across jurisdictions?
- What data fields are required to build an Orange Book exclusivity and patent expiration timeline?
- How do Paragraph IV settlements typically shift generic entry risk for ophthalmic products?
- Which patent claim types most often survive design-around attempts for topical ophthalmic formulations?
- What commercial indicators best predict erosion timing after generic entry for branded anti-inflammatory drops?
References
- FDA, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via session context).
- FDA. Paragraph IV patent certification and ANDA framework (FDA guidance and statute references). (accessed via session context).
- 35 U.S.C. § 156 and related provisions on patent term extension. (general statutory reference).
- Hatch-Waxman Act exclusivity framework (general statutory reference).
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