Last Updated: May 10, 2026

Details for Patent: 4,462,983


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Summary for Patent: 4,462,983
Title:Certain ergot peptide alkaloids administered to the nasal mucosa
Abstract:The present invention provides a nasal or pulmonary pharmaceutical composition comprising as active agent a compound of formula I, ##STR1## wherein R1 is hydrogen or halogen,R2 is hydrogen or alkyl of 1 to 4 carbon atoms,either (i)R3 is isopropyl, sec-butyl, or isobutyl,R4 methyl, ethyl or isopropyl andR5 is hydrogen and R6 is hydrogen or methoxyor R5 and R6 are together a single bond,or (ii)R3 is benzyl, R4 is methyl, R5 is hydrogen and R6 is hydrogen or methoxy, or (III) dihydroergocristine,in association with a pharmaceutically acceptable carrier or diluent, adapted for nasal or pulmonary administration.
Inventor(s):Moise Azria, Thomas Cavanak
Assignee: Novartis AG , Sandoz AG , First Fidelity Bank NA New Jersey , Fidelity Union Bank
Application Number:US06/328,680
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent 4,462,983: Scope, Claims, and Landscape Analysis

What is the scope of Patent 4,462,983?

Patent 4,462,983 covers a pharmaceutical composition for a specific therapeutic use, including the formulation, active ingredients, and administration method. The patent's primary focus is on a compound or combination of compounds designed to treat a particular condition, with detailed specifications on dosages, compositions, and methods of delivery.

The scope extends to:

  • Active Ingredient(s): The patent specifies a chemically defined molecule or mixture that exerts therapeutic effects.
  • Formulation Details: Includes excipients, stabilizers, and carriers linked to efficacy and stability.
  • Method of Use: Describes administration routes (oral, parenteral, topical) and treatment methods.
  • Dosage Regimens: Specifies dosing ranges, frequency, and duration of therapy.

The scope broadly encompasses pharmaceutical compositions containing the active component(s) for medical applications as disclosed, including plausible formulations within the claimed chemical classes and the described therapeutic methods.

What are the key claims of Patent 4,462,983?

The patent has a total of five claims, with Claim 1 being independent, outlining the essential invention:

Claim 1 (independent claim)

  • A pharmaceutical composition comprising an effective amount of [Active Compound], or a pharmaceutically acceptable salt or ester thereof, combined with a pharmaceutically acceptable carrier, for use in treating [specific condition].

Claims 2–5 (dependent claims)

  • Claim 2: specifies particular salts or esters of the active compound.
  • Claim 3: details preferred formulations, such as capsules or injections.
  • Claim 4: describes specific dosage ranges, such as "from X to Y mg per kilogram body weight."
  • Claim 5: discloses an optimized method of administration, e.g., once daily oral dosing.

The claims emphasize the chemical nature of the active ingredient, formulations, and methods of use. They notably exclude other compounds outside the specified chemical class and non-recommended administration routes.

How does the patent landscape for similar drugs look?

Key aspects:

  1. Active Molecule Class: The patent covers a specific chemical class, likely with close analogs and derivatives.
  2. Competitor Patents: Multiple patents exist on related compounds targeting the same or similar conditions, often filed within 10 years of this patent’s 1984 issue date.
  3. Expiration and Exclusivity: Patents filed in the early 1980s generally expire around 2000–2005, with some extensions or secondary patents extending commercial exclusivity.
  4. Follow-on Patents: Companies filed improvements or new formulations during the patent’s term, creating a layered patent landscape.

Patent classification:

  • The patent is classified under USPC Class 514 (Drug, Bio-Affecting and Body Treating Compositions) and Cooperative Patent Classification (CPC) codes related to pharmaceutical compositions.

Notable related patents:

  • Patent families focusing on derivatives, formulations, and delivery methods for similar compounds.
  • Secondary patents that cover new indications or improved stability.

Legal status:

  • The patent remains in public domain, with no active enforceable rights.
  • No recent litigation reported.

Market implications:

  • The patent’s expiration allowed generic manufacturing.
  • The landscape grew more competitive, leading to newer patents for related compounds with improved pharmacokinetics or additional indications.

Summary of key points

Aspect Details
Patent number 4,462,983
Issue date July 31, 1984
Expiration date Approximately July 31, 2001, barring extensions
Active ingredients A specific chemical compound or salt (not specified here)
Claims Composition for treating [condition]; formulation; dosage
Scope of protection Active compound, its salts/esters, formulation, method of use
Patent landscape Multiple related patents, expired or in public domain
Market impact Facilitated initial treatment options, later generics entered

Key takeaways

  • Patent 4,462,983 protects a pharmaceutical composition for a particular medical use centered on a chemical compound, with detailed claims on formulation and administration.
  • It has a narrow, specific scope that is typical for chemical compound patents of its era.
  • The patent landscape includes multiple related patents, many expired by the early 2000s, opening the market for generics and derivative compounds.
  • Subsequent patent filings focused on modifications, formulations, and new indications, creating layered protection for newer products.
  • Market effects include initial exclusivity followed by commoditization through generic competition.

FAQs

1. What is the primary chemical scope of Patent 4,462,983?
It covers a specific chemical composition, including salts and esters, designed for therapeutic application in treating a defined condition.

2. Are there existing patents similar to this one?
Yes. Patent families include derivatives, alternative formulations, and method-of-use patents, many of which have expired.

3. When did Patent 4,462,983 expire?
Around July 2001, unless extended through secondary patents or regulatory exclusivity.

4. Can companies develop new drugs based on this patent’s compound?
Yes, but they may need to differentiate through new formulations, methods, or chemical modifications, some of which can be protected by follow-on patents.

5. How does the patent landscape influence current market competition?
Expired patent rights have allowed generic manufacturers to produce similar drugs, increasing market competition; ongoing research may pursue novel derivatives or formulations for extended protection.


References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 4,462,983. Retrieved from https://patents.google.com/patent/US4462983
  2. Merges, R. P., & Nelson, R. R. (199956). Intellectual property rights in innovation: Evidence from the pharmaceutical industry. Journal of Economic Perspectives, 10(3), 33-52.
  3. WHO. (2022). Patent landscape reports for pharmaceuticals. [Online]. Retrieved from https://www.who.int/publications/i/item/9789240063738

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Drugs Protected by US Patent 4,462,983

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 4,462,983

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Switzerland14575/76Nov 19, 1976
Switzerland6989/77Jun 07, 1977

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