Renewed opportunities for established molecules
Established molecules can continue to create meaningful portfolio opportunities when supported by the right product configuration, updated dossier and market strategy. Reformulation can help pharmaceutical companies revisit familiar therapeutic areas, address evolving portfolio requirements and prepare for future registration and commercial opportunities.
Remediated Dossiers
The Medis reformulation focus portfolio highlights selected established molecules that are undergoing product or dossier updates. These products were brought into focus because they may offer partners opportunities to refresh, extend or strengthen existing portfolios, while building on molecules already recognized within their therapeutic categories.
By providing earlier visibility, Medis aims to support timely customer discussions and enable partners to assess potential portfolio fit, strength coverage, dosage-form requirements and future market relevance. Reformulation status and anticipated timing vary by product, and dossier configuration, registration pathways, territorial access and commercial readiness must be evaluated individually.
For more information and to explore the suitability and timing of a pipeline opportunity for your desired market, please contact your relevant Medis Business Development Manager.
Central Nervous System
Alprazolam
A four-strength anxiolytic tablet portfolio undergoing reformulation.
- Dosage form: Tablet
- Strengths: 0.25 mg, 0.5 mg, 1 mg and 2 mg
- Therapeutic area: Nervous system
- Key indication: Anxiety
- Product class: Anxiolytic
- Dossier status: Available
- Stability coverage: Zone II
- Estimated CPP timing: Q1 2028
The dossier information includes restrictions. Customer, territory and applicable controlled-medicine requirements must therefore be evaluated individually.
Pregabalin
A broad-strength central nervous system reformulation opportunity.
- Dosage form: Hard capsule
- Strengths: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
- Therapeutic area: Nervous system
- Key indication: Neuropathic pain
- Product class: Analgesic
- Expected dossier availability: Q1 2027
- Stability coverage: Zone IVb
- Estimated CPP timing: Q2 2028
The eight-strength presentation provides the broadest strength range within the selected reformulation portfolio.
Cardiovascular Health
Atenolol
A three-strength beta-blocker opportunity undergoing reformulation.
- Dosage form: Tablet
- Strengths: 25 mg, 50 mg and 100 mg
- Therapeutic area: Cardiovascular
- Key indication: Hypertension
- Product class: Beta-blocking agent
- Dossier status: Available
- Stability coverage: Zone II
- Estimated CPP timing: Available
The three-strength presentation may be relevant to partners maintaining or expanding established cardiovascular portfolios.
Bisoprolol Fumarate
A broad cardiovascular portfolio opportunity with six strengths.
- Dosage form: Film-coated tablet
- Strengths: 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg
- Therapeutic area: Cardiovascular
- Key indication: Hypertension
- Product class: Beta-blocking agent
- Expected dossier availability: Q3 2026
- Stability coverage: Zone IVb
- Estimated CPP timing: Q3 2028
The six-strength range supports broad product coverage across different prescribed strengths.
Lisinopril
A six-strength ACE-inhibitor opportunity undergoing reformulation.
- Dosage form: Film-coated tablet
- Strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg
- Therapeutic area: Cardiovascular
- Key indication: Hypertension
- Product class: ACE inhibitor
- Expected dossier availability: Q3 2027
- Stability coverage: Zone II
- Estimated CPP timing: Q2 2029
The extensive strength range may support future cardiovascular portfolio development and continuity.
Losartan
A four-strength angiotensin II receptor blocker opportunity undergoing reformulation.
- Dosage form: Film-coated tablet
- Strengths: 12.5 mg, 25 mg, 50 mg and 100 mg
- Therapeutic area: Cardiovascular
- Key indication: Hypertension
- Product class: Angiotensin II receptor blocker
- Expected dossier availability: Q3 2026
- Stability coverage: Zone IVb
- Estimated CPP timing: Q3 2028
The selected focus opportunity covers Losartan as a single active ingredient and should be clearly separated from combination products.
Gastroenterology
Esomeprazole Capsules
A gastro-resistant capsule reformulation associated with gastroesophageal reflux disease.
- Dosage form: Gastro-resistant capsule
- Strengths: 20 mg and 40 mg
- Therapeutic area: Alimentary tract and metabolism
- Key indication: Gastroesophageal reflux disease
- Product class: Peptic ulcer and gastro-oesophageal disease treatment
- Expected dossier availability: Q4 2026
- Stability coverage: Zone II
- Estimated CPP timing: Q3 2028
This capsule reformulation should be clearly differentiated from the commercially available Esomeprazole gastro-resistant tablet presented earlier on the page.
Important Product Information
Medis partners with pharmaceutical companies and does not supply medicines directly to patients or healthcare professionals.
The information presented on this page is intended exclusively for business-to-business discussions. Product specifications, dosage forms, strengths, indications, dossier status, development timing, manufacturing arrangements, intellectual-property position, registration pathway, marketing-authorization availability, supply conditions and launch timing may vary by country and may change.
A dossier described as available may not necessarily be immediately suitable for submission or commercial launch in every territory. Additional development, documentation, regulatory activities or market-specific requirements may apply.
Indications shown are high-level portfolio descriptors and do not constitute prescribing information, medical advice or confirmation of an approved indication in a particular country.
For detailed product information and to assess the suitability of an opportunity for your desired market, please contact your relevant Medis Business Development Manager.