CLINICAL TRIALS PROFILE FOR ROBINUL FORTE

All Clinical Trials for ROBINUL FORTE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00579085 ↗	Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS	Completed	Drexel University College of Medicine	Phase 2	2006-09-01	Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS.
NCT01191398 ↗	Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation	Completed	Craig J. Huang	N/A	2010-06-01	The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
NCT02872935 ↗	Minimizing Nausea and Vomiting During Spinals for CS	Terminated	Kokila N Thenuwara	Phase 4	2015-05-15	In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT02872935 ↗	Minimizing Nausea and Vomiting During Spinals for CS	Terminated	University of Iowa	Phase 4	2015-05-15	In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT03513757 ↗	Dexmedetomidine and Propofol for Pediatric MRI Sedation	Completed	Medical College of Wisconsin	Phase 4	2018-03-04	The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.

Clinical Trial Conditions for ROBINUL FORTE

Condition Name

Condition Name for ROBINUL FORTE
Intervention	Trials
Spine Deformity	1
Surfactant Deficiency Syndrome Neonatal	1
Abdominal Neoplasm	1
Tumor	1

Condition MeSH

Condition MeSH for ROBINUL FORTE
Intervention	Trials
Neurofibromatosis 1	1
Vomiting	1
Neurofibromatoses	1
Nausea	1

Clinical Trial Locations for ROBINUL FORTE

Trials by Country

Trials by Country for ROBINUL FORTE
Location	Trials
United States	4
Canada	1
Finland	1

Trials by US State

Trials by US State for ROBINUL FORTE
Location	Trials
Wisconsin	1
Iowa	1
Texas	1
Pennsylvania	1

Clinical Trial Progress for ROBINUL FORTE

Clinical Trial Phase

Clinical Trial Phase for ROBINUL FORTE
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for ROBINUL FORTE
Clinical Trial Phase	Trials
Completed	3
Recruiting	1
Terminated	1

Clinical Trial Sponsors for ROBINUL FORTE

Sponsor Name

Sponsor Name for ROBINUL FORTE
Sponsor	Trials
University of Iowa	1
Medical College of Wisconsin	1
Oulu University Hospital	1

Sponsor Type

Sponsor Type for ROBINUL FORTE
Sponsor	Trials
Other	9

Robinul Forte (glycopyrrolate) clinical trials update, market analysis, and exclusivity/patent projection

Last updated: July 28, 2026

Robinul Forte is an oral brand of glycopyrrolate (anticholinergic). Public clinical-trials signals are sparse, with the product class anchored in established off-patent, low-growth symptomatic use rather than late-stage, differentiated development. A defensible market projection requires brand-level revenue and exclusivity context, which is not available in the information provided.

Clinical trials update for Robinul Forte: What studies are active or recruiting for glycopyrrolate oral anticholinergic use?

What is Robinul Forte in clinical-trials terms?

• Active ingredient: glycopyrrolate (anticholinergic).
• Form: oral tablets (brand name “Robinul Forte” is typically used in asthma/respiratory secretions and related indications, depending on local labeling).
• Clinical development posture: no clear late-stage randomized program tied to the brand name is evident from the information provided.

Are there late-stage trials (Phase 3/2b) for glycopyrrolate oral formulations?

• None identified in the provided data.
• No Phase 3 timeline, primary endpoints, comparators, or enrollment windows can be stated.

What endpoints typically appear for glycopyrrolate in trials? Commonly reported outcomes in glycopyrrolate research across pediatric secretions, sialorrhea, and related indications include:

• saliva drooling severity scales,
• caregiver-reported secretion burden,
• aspiration-related events and respiratory adverse events,
• anticholinergic tolerability (dry mouth, constipation, urinary retention).

No specific Robinul Forte trial endpoints or effect sizes are available from the provided information.

How does Robinul Forte’s trial activity compare with the glycopyrrolate class?

• The drug category is mature; clinical activity often shifts to:
  • pediatric sialorrhea treatment,
  • route/formulation studies,
  • comparative efficacy vs other anticholinergics (e.g., atropine, scopolamine, trihexyphenidyl depending on indication),
  • combination regimens.
• No brand-linked development comparison can be quantified without identifiers and trial listings.

What is the market for Robinul Forte today: How big is glycopyrrolate anticholinergic demand and who buys it?

Commercial framing

• Robinul Forte is a symptomatic, anticholinergic therapy. Demand drivers typically include:
  • pediatric and adult secretions management,
  • neurologic disease care pathways (label-dependent),
  • chronic use patterns where tolerated.

Market sizing and geography

• No market size figures, country sales, or channel data are included in the provided information.
• No unit consumption, prescriptions, or wholesaler movement can be projected.

Pricing and payer dynamics

• No net price, rebate, or reimbursement ranges are provided.
• No plan-tier placement data is available.

Competitive landscape for oral glycopyrrolate

• Without the needed formulary and branded/generic status by country, the competitive set cannot be listed with precision for:
  • tablets vs liquid,
  • pediatric dosing products,
  • branded vs generic shares.

What generic entry risks exist for Robinul Forte, and when does exclusivity end?

FDA/Orange Book status

• The provided information does not include FDA product identifiers, NDA/ANDA numbers, or Orange Book listings.
• A reliable exclusivity statement cannot be produced.

Patent and exclusivity projection

• No patent numbers, assignee, filing/grant/expiration dates, or Orange Book exclusivities are included.
• A “when does it lose exclusivity” or “paragraph IV risk” view cannot be stated.

Biosimilar risk

• Not applicable: glycopyrrolate is a small molecule.

How strong is the patent estate for glycopyrrolate tablet products like Robinul Forte?

• Patent strength cannot be assessed without the actual estate.
• Litigation risk cannot be evaluated without docket-level identifiers.

What formulations are protected for Robinul Forte: Are there tablet-specific composition, method-of-use, or manufacturing patents?

Formulation IP buckets When present in this class, IP typically falls into:

• composition of matter (salt form, polymorph, specific active/excipient ratios),
• formulation patents (release rate, particle size strategy),
• method-of-use (indication-specific dosing regimens),
• manufacturing process patents (granulation, compression, drying, moisture control).

Robinul Forte-specific protection

• No formulation patent list is included in the provided information.
• No protected dosage strengths or release mechanics can be assigned to the brand.

How does Robinul Forte compare with other glycopyrrolate products and anticholinergic alternatives?

Within glycopyrrolate

• Comparable oral products: generic glycopyrrolate tablets/liquids in various strengths (country dependent).
• Without regulatory and listing data, relative efficacy and tolerability comparisons cannot be tied to Robinul Forte.

Against alternatives In secretions/sialorrhea and related uses, alternatives may include:

• atropine (oral drops or ophthalmic-derived regimens off-label depending on jurisdiction),
• scopolamine (transdermal, patch),
• other anticholinergics with different CNS penetration profiles depending on indication.

No comparative clinical evidence specific to Robinul Forte is provided.

What patent litigation affects Robinul Forte or glycopyrrolate tablets?

• No litigation docket, settlement, or court findings are included in the provided information.
• A Paragraph IV narrative, settlement-trigger details, or “launch-blocked until” dates cannot be produced.

Clinical development strategy projection for Robinul Forte: What are the realistic next moves for sponsors?

Given the absence of brand-linked late-stage signals in the provided data, realistic sponsor options for a mature small-molecule anticholinergic typically include:

• line extensions (new dose strengths, pediatric packaging),
• route/formulation improvements (liquid, dispersible, alternate release),
• label expansions via Phase 2/3 or bridging studies depending on jurisdiction.

No sponsor strategy or timeline can be asserted for Robinul Forte specifically without trial registry and regulatory pathway data.

Market projection for Robinul Forte: Revenue and demand outlook for the next 5–10 years

Projection mechanics that require missing inputs A rigorous projection needs at minimum:

• historical brand/unit sales by geography,
• net pricing and discount trajectory,
• market size for labeled indications,
• generic share trends and competitive entry timing,
• reimbursement changes.

These inputs are not present in the provided information, so a quantified revenue projection cannot be produced.

Key Takeaways

• Robinul Forte is a glycopyrrolate anticholinergic brand, but the provided inputs contain no trial registry details, Orange Book/NDA/ANDA identifiers, patent lists, exclusivity triggers, or revenue history.
• Without those data, no defensible clinical trials update, patent/exclusivity timeline, or quantified market/revenue projection can be stated.
• The most decision-relevant analysis elements (active trials, patent expiration, Paragraph IV/settlement dates, and market sizing) are not available in the provided information.

FAQs

1. What is Robinul Forte used for clinically (labeled indications) and in which patient populations?
2. Is glycopyrrolate oral tablet development ongoing, and which trial phases are most active?
3. What does Orange Book listing typically look like for small-molecule oral anticholinergics, and how is exclusivity calculated?
4. How do generic manufacturers typically enter glycopyrrolate tablet markets, and what are the common IP barriers?
5. What tolerability differences matter most among oral glycopyrrolate versus other anticholinergics for secretion control?

References

1. (No citations available from the provided information.)