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Suppliers and packagers for MINIPRESS
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MINIPRESS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-431-85 | 90 CAPSULE in 1 BOTTLE (66993-431-85) | 2021-08-25 |
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-432-85 | 90 CAPSULE in 1 BOTTLE (66993-432-85) | 2022-03-11 |
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-433-85 | 90 CAPSULE in 1 BOTTLE (66993-433-85) | 2022-03-11 |
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | REMEDYREPACK INC. | 70518-3271-0 | 30 POUCH in 1 BOX (70518-3271-0) / 1 CAPSULE in 1 POUCH (70518-3271-1) | 2021-11-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
MINIPRESS suppliers: who makes prazosin (tablets) and how the supplier landscape maps to US regulatory and patent risk
MINIPRESS is a brand of prazosin (oral tablets). The supply chain is split between (1) generic/brand tablet manufacturers supplying the US market and (2) contract manufacturers handling formulation, tablet compression, and packaging, with active pharmaceutical ingredient (API) sourced globally. The cleanest way to identify “suppliers” for MINIPRESS in the US is the FDA Orange Book (Reference Listed Drug) and the ANDA label/labeler listings, then map manufacturers to licensing and patent status where relevant.
Who supplies MINIPRESS (prazosin) in the US market?
Answer: MINIPRESS is supplied in the US through the brand’s manufacturer (where stocked and distributed) and multiple generic prazosin hydrochloride tablet suppliers listed in the FDA Orange Book. In practice, most “supplier” inquiries resolve to labeler/manufacturers on the Orange Book record for prazosin tablets, not to an exclusive upstream API source.
What counts as a “supplier” for MINIPRESS?
- Drug product labeler / applicant: the FDA-listed entity on the Orange Book for the ANDA/brand record.
- Manufacturing site(s): listed under “Manufactured for” / “Manufacturing” in the labeling for the generic product (often CMOs and packagers).
- API manufacturers: usually not fully disclosed in public Orange Book records; identified through DMF holder disclosures, inspectional records, and downstream supply chain mapping.
What is the FDA Orange Book status of MINIPRESS (prazosin tablets)?
Answer: MINIPRESS (prazosin hydrochloride) is an older, off-patent small-molecule with generic prazosin tablets typically available. Orange Book records for prazosin tablets list multiple approvals with active marketing labelers, but the brand exclusivity window is long expired.
Where to find supplier identities
Orange Book record fields used in supplier mapping:
- Applicant holder (brand or ANDA firm)
- Dosage form / strength
- Marketing status (e.g., “Marketed,” “Discontinued,” “Withdrawn”)
- Patent listings (if any) and expiration dates
How supplier counts change by strength
Prazosin is sold in multiple tablet strengths. Supplier visibility varies by:
- Strength-specific labeling
- Whether a specific ANDA is marketed consistently
- Temporary shortages that shift sourcing to other labelers
How many ANDA suppliers make prazosin tablets that compete with MINIPRESS?
Answer: Multiple ANDA applicants typically market prazosin hydrochloride tablets, and the supplier base can be broad because prazosin is a mature generic.
Why supplier counts can look higher than expected
- Separate ANDAs may exist for different strengths
- Same labeler may use multiple manufacturing sites
- Some products are marketed through relabelers or distributors while the ANDA applicant remains the same
Which companies manufacture prazosin tablets sold as generics under labels that compete with MINIPRESS?
Answer: Generic prazosin tablet manufacturers are identified through Orange Book “applicant/holder” and the drug product labeling. A robust supplier map must be built from those FDA entries for each strength.
Supplier mapping workflow used in practice
- Step 1: pull prazosin hydrochloride tablet entries in Orange Book
- Step 2: record applicant/labeler and manufacturing location from each marketed strength
- Step 3: group by company and by site
- Step 4: flag records with changes in manufacturing site or marketing status
What patent estate affects MINIPRESS supplier freedom to operate?
Answer: For a mature drug like prazosin, supplier freedom to operate is usually shaped by any remaining listed patents at the Orange Book record level. In most market cases for older small molecules, the patent estate does not block standard generic supply.
Patent estate impact points
- If any Orange Book patents are still listed for prazosin tablets, they can affect:
- launch timing of new strengths
- certain formulation or method-of-use embodiments (less likely for prazosin tablets)
- If patents are expired or not listed, supplier risk drops materially
What patent litigation or Paragraph IV challenges exist for prazosin tablets vs MINIPRESS?
Answer: For widely marketed generic prazosin, supplier risk from patent litigation is generally limited to earlier time windows. Current supplier changes are more often driven by:
- manufacturing capacity
- GMP compliance
- supply chain disruptions than active Paragraph IV disputes.
Common litigation-driven supplier shifts (market pattern)
- settlement-driven exclusivity windows
- consent decrees limiting “launch until” dates
- site-specific approvals affected by inspection outcomes
What formulations are protected for prazosin tablets (and does that limit suppliers)?
Answer: For legacy prazosin tablet products, the competitive product space is typically limited to differences in:
- strength
- excipient composition at the formulation-detail level
- coating or tablet imprint (not usually a major IP barrier for generic tablets)
What formulation patents would matter commercially
- controlled-release or novel delivery approaches (unlikely for standard prazosin tablet)
- bioequivalence-sensitive compositions (not typical for mature prazosin)
Which manufacturing contractors (CMOs) make prazosin tablets for brand or generic labelers?
Answer: The manufacturing site is usually disclosed on the product labeling, but public sources rarely provide a single upstream “CME/CMP list.” For supplier procurement, what matters is the site name listed in labeling and Orange Book.
Typical CMO roles in tablet supply chains
- API formulation and wet/granulation (if used)
- tableting (compression)
- coating (if applicable)
- packaging and secondary labeling
- quality control release testing
When does MINIPRESS lose exclusivity in the US, and what does that mean for suppliers?
Answer: MINIPRESS is not protected by current-use regulatory exclusivity timelines in the way newer drugs are. The effect of exclusivity is that generic entrants can market once patent/exclusivity barriers are removed.
How to interpret exclusivity vs patent listings
- Orange Book patents govern generic entry timing
- Regulatory exclusivity (5-year/7-year/12-year regimes) does not usually apply to legacy drugs like prazosin
What generic entry risks exist for MINIPRESS (prazosin) going forward?
Answer: Supplier risk for an established generic drug is usually not tied to exclusivity. The highest practical risks are:
- manufacturing constraints or GMP issues at key sites
- shortages that force substitutions across labelers
- supply chain concentration in API procurement
How do MINIPRESS and generic prazosin tablet suppliers differ clinically and regulatorily?
Answer: Clinically, generics must meet FDA standards for bioequivalence. The supplier differentiation is primarily:
- quality systems and inspection performance
- manufacturing site qualification and batch release
- stability and packaging specs
What procurement teams typically evaluate
- latest GMP inspection outcomes for the manufacturing site
- whether the ANDA has recent approvals or manufacturing changes
- CoA turn-around time and release lead time
Supplier landscape by dosage strength: what changes between 0.5 mg, 1 mg, and 2 mg?
Answer: Supplier coverage can vary by strength due to:
- different ANDAs for different strengths
- site qualification for each strength
- tablet tooling and compression line allocation
Which geographies supply prazosin API and tablets to the US?
Answer: Generic APIs and tablets are commonly sourced through global supply chains, with production frequently located in Asia and distributed via US labelers. However, exact API country-of-origin for a given labeler is not consistently visible from Orange Book fields alone; procurement teams usually confirm via:
- CoA
- import records
- supplier master data
Key Takeaways
- “MINIPRESS suppliers” in the US are best identified by the FDA Orange Book entries for prazosin hydrochloride tablets, capturing each marketed applicant/labeler and manufacturing site.
- MINIPRESS is a mature small molecule; supplier competition is primarily a function of generic ANDA market participation, manufacturing capacity, and GMP performance.
- Patent and exclusivity barriers that would block generic supply are typically not active for legacy prazosin tablets, so supplier risk is more operational than legal.
FAQs
-
How do I identify the US labeler/manufacturing sites for prazosin hydrochloride tablets competing with MINIPRESS?
Use the FDA Orange Book entries for prazosin tablets by strength, then cross-check the same applicant and marketed labeling. -
Do prazosin hydrochloride tablet generics have formulation patents that restrict suppliers?
For legacy prazosin tablets, supply restrictions are usually not driven by active formulation patents in the way newer drug platforms are. -
What causes sudden supplier changes for prazosin tablets?
Manufacturing capacity limits, batch release issues, and site-specific GMP findings are more common drivers than exclusivity. -
Are there multiple manufacturing sites for the same prazosin tablet applicant?
Yes. Many applicants use multiple qualified sites; labeling and Orange Book site info should be used for site-level diligence. -
What is the most actionable source for building a supplier shortlist for MINIPRESS-equivalent prazosin tablets?
The FDA Orange Book plus the current marketed labels for each strength, mapped to the manufacturing sites listed there.
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
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