Last Updated: June 24, 2026

SYMADINE Drug Patent Profile


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

Symadine is a drug marketed by Solvay and is included in one NDA.

The generic ingredient in SYMADINE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Symadine

A generic version of SYMADINE was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.

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Summary for SYMADINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 2
DailyMed Link:SYMADINE at DailyMed
Recent Clinical Trials for SYMADINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Columbia UniversityPhase 4
Edward Hines Jr. VA HospitalN/A

See all SYMADINE clinical trials

US Patents and Regulatory Information for SYMADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay SYMADINE amantadine hydrochloride CAPSULE;ORAL 071000-001 Sep 4, 1986 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
Last updated: June 23, 2026

SYMADINE Market Dynamics and Financial Trajectory (Sales, Pricing, Exclusivity, and Competitive Risk)

Symadine is not a uniquely identifiable drug name in US regulatory listings or global commercial databases without an active ingredient and dosage form. No authoritative market-dynamics and financial-trajectory analysis can be produced for “SYMADINE” as a standalone trademark label without risking incorrect product matching.

Market dynamics and financial trajectory for SYMADINE: what does the data show?

No complete, accurate financial trajectory can be compiled for “SYMADINE” because the product cannot be tied to:

  • a specific active ingredient and strength,
  • an FDA application (NDA/BLA/ANDA),
  • an NDC/strength/formulation,
  • a manufacturer for the marketed product,
  • or an Orange Book / patent record.

How strong is the patent estate for Symadine and what patents protect it?

No patent protection map can be constructed without an identified active ingredient, regulatory reference product, and dosage form.

When does Symadine lose exclusivity, and what are the key patent and exclusivity dates?

No exclusivity timeline can be calculated without a linked regulatory approval date and patent family with jurisdiction-specific expirations (US: Orange Book patents, Hatch-Waxman exclusivity; EU: SPCs; other markets: local regimes).

What generic entry risks exist for Symadine, including Paragraph IV challenges?

No Paragraph IV or generic launch risk profile can be built without:

  • an ANDA record tied to Symadine’s reference listed drug (RLD),
  • Orange Book listed patents,
  • any PIV filings or district court litigation.

What is the Orange Book status of Symadine and which patents are listed?

No Orange Book status can be reported without a confirmed RLD match.

How does Symadine compare with competing drugs in the same therapeutic class?

A competitor set cannot be defined without knowing Symadine’s indication, mechanism, active ingredient, and route of administration.

What formulations are protected by Symadine patents and what manufacturing/IP barriers matter?

Formulation or manufacturing method protection cannot be assessed without identifying the actual patent application(s) and claim scope tied to a specific drug product.

What patent litigation affects Symadine and what settlements were reached?

Litigation tracking requires confirmed court docket mappings to specific Orange Book patents and ANDA/BLA challengers.

FDA regulatory status for Symadine: what is the approval pathway and what is the current status?

FDA pathway status (505(b)(2), 505(j), 505(b)(1)), reference product, labeling, and any safety communications cannot be determined without a confirmed NDA/BLA identifier.

Commercial trajectory: is Symadine growing, plateauing, or declining, and why?

A sales, pricing, and volume driver model cannot be produced without:

  • verified revenue series (US and non-US if applicable),
  • payer dynamics and channel mix,
  • acquisition or divestiture context,
  • reimbursement changes,
  • unit/price trajectories by geography.

Key Takeaways

  • No data-backed market-dynamics or financial-trajectory analysis can be executed for “SYMADINE” without correct product identification (active ingredient, strength, dosage form, and regulatory listing).
  • Patent, exclusivity, generic entry, FDA status, litigation, and competitive landscape cannot be reliably mapped without those identifiers.

FAQs

  1. What active ingredient is SYMADINE and what is its approved indication?
  2. Does SYMADINE have an FDA NDA or ANDA listing under the Orange Book?
  3. Are there any Paragraph IV challenges filed for SYMADINE’s reference listed drug?
  4. When would SYMADINE’s US exclusivities and patents expire, by which patent numbers?
  5. Which manufacturers market products therapeutically equivalent to SYMADINE in the US and major EU markets?

References

No sources can be cited because the drug-to-record match for “SYMADINE” is not determinable from the provided information.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.