GenBioPro

What GenBioPro does

GenBioPro, Inc. is a privately held pharmaceutical company headquartered in Las Vegas, Nevada, founded in 2012 to expand access to medical abortion in the United States. The company manufactures and distributes two FDA-approved generic pharmaceutical products: generic mifepristone tablets, 200mg (ANDA 091178, approved April 11, 2019) — the first FDA-approved generic mifepristone in the US, AB-rated to Mifeprex (Danco Laboratories) — and generic misoprostol tablets, 200mcg (approved July 2, 2019), AB-rated to Cytotec. The two drugs are used together as a combination regimen for medical termination of intrauterine pregnancy through 70 days gestation, with a documented 97% overall effectiveness rate.

The company operates a dual-channel B2B distribution model under the FDA's Risk Evaluation and Mitigation Strategy (REMS) program. In one channel, certified prescribers (physicians, nurse practitioners, and other qualified providers) order directly through authorized distributors for in-clinic dispensing. In the second channel, prescriptions are routed to certified pharmacies — including national chains (CVS in 22+ states + DC), mail-order pharmacies (Honeybee Health), and regional independents — for in-store pickup or mail delivery. Both prescribers and pharmacies must execute Prescriber/Pharmacy Agreements and meet REMS certification requirements. The 2023 FDA decision to permanently remove in-person dispensing requirements enabled telemedicine prescribing and pharmacy dispensing, materially expanding the addressable market.

GenBioPro generates revenue primarily through unit-priced product sales of generic mifepristone (the vast majority of revenue, per company materials) and secondarily through generic misoprostol. Pricing is not publicly disclosed. The company has positioned its generic mifepristone as a cost-efficient alternative to the brand Mifeprex, and its product is used in approximately 60-63% of US abortions annually — a market of more than 600,000 medical abortion patients per year. GenBioPro is actively engaged in legal advocacy to defend FDA regulations on mifepristone access, intervening in multiple state-level lawsuits (Missouri, Idaho, Kansas, Louisiana, Texas, West Virginia, Mississippi) and securing a Supreme Court stay against Louisiana's in-person dispensing requirement in 2026.

Name

GenBioPro

Legal name

GenBioPro, Inc.

Website

https://genbiopro.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

GenBioPro is a privately held Las Vegas-based pharmaceutical company that manufactures and distributes the first FDA-approved generic mifepristone (200mg) and generic misoprostol (200mcg) for medical abortion in the US, selling to certified prescribers and pharmacies under the FDA REMS program.

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule Generics (Branded/Unbranded) (HLAIABAA)

akta.pro secondary industry

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

Keywords

• Generic pharmaceuticals
• Reproductive health drugs
• Medical abortion medications
• FDA approved generics
• Women's health therapeutics

Headquarters

HQ city

Las Vegas

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Generic Mifepristone Sales: GenBioPro manufactures and sells generic mifepristone tablets, 200mg, for medical abortion. The company generates revenue through product sales to certified prescribers (for in-clinic dispensing) and certified pharmacies. For GenBioPro, the drug represents the vast majority of total revenue. Product is distributed through authorized distributors with 2nd day air shipping.
2. Generic Misoprostol Sales: GenBioPro also manufactures and sells generic misoprostol tablets, 200mcg, sold in 48-unit packs (12 individual 4-count blister packs to a carton). Revenue generated through product sales to healthcare providers and pharmacies.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels5 records

Core offering

GenBioPro manufactures and sells FDA-approved generic mifepristone tablets 200mg and generic misoprostol tablets 200mcg for medical termination of intrauterine pregnancy through 70 days gestation. Products are distributed through a network of certified prescribers and certified pharmacies operating under an FDA REMS (Risk Evaluation and Mitigation Strategy) restricted distribution program, with dispensing available via in-clinic, mail-order, and in-store pharmacy channels.

Product overview

GenBioPro is a pharmaceutical company offering a focused portfolio of two FDA-approved generic reproductive health products. The core offering consists of generic mifepristone tablets, 200 mg (launched April 2019) and generic misoprostol tablets, 200 mcg (launched July 2019), which are used together in a combined regimen for medical abortion up to 70 days gestation. Both products are AB-rated equivalents to their respective brand-name counterparts (Mifeprex and Cytotec) and are available through certified prescribers and pharmacies. The company also provides patient education resources, prescriber certification programs, and pharmacy dispensing services under FDA REMS requirements.

Differentiator

Problem solved

Functional benefit

Products and services

• Generic Mifepristone Tablets, 200 mg FDA-approved generic mifepristone tablets (200 mg) indicated for medical termination of intrauterine pregnancy through 70 days gestation, used in combination with misoprostol. The first FDA-approved generic medical abortion pill in the US, AB rated to Mifeprex, supplied to certified prescribers and certified pharmacies under the FDA REMS restricted distribution program.
• Generic Misoprostol Tablets, 200 mcg FDA-approved generic misoprostol tablets (200 mcg) used in combination with mifepristone for medical abortion. AB rated to Cytotec, sold in 48-unit packs (12 individual 4-count blister packs per carton), distributed to certified prescribers and pharmacies.

Quantifiable outcome

• 97% overall success rate for medical abortion using mifepristone and misoprostol regimen
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature3 records

Partnerships

Five partnerships are on record, tiered core.

• Democracy Forward FoundationcoreImplementation/ SI/ Consulting Partner · 3 February 2026Legal advocacy organization representing GenBioPro in lawsuits defending FDA regulations on medication abortion. GenBioPro retained Democracy Forward Foundation and Arnold & Porter for legal representation in interventions in multiple lawsuits including Missouri v. FDA and Louisiana v. FDA.
• Arnold & PortercoreImplementation/ SI/ Consulting Partner · 3 February 2026Law firm retained by GenBioPro for legal representation in defending medication abortion access through court interventions and amicus briefs in Supreme Court and appellate court cases challenging FDA mifepristone regulations.
• CVS PharmacycoreChannel Partner/ Reseller/ DistributorNational pharmacy chain certified to dispense GenBioPro generic mifepristone. CVS fills prescriptions in 22 states and DC including California, New York, Illinois, and other major markets. Prescribers submit Prescriber Agreement once to cover all participating CVS locations.
• Honeybee HealthcoreChannel Partner/ Reseller/ DistributorMail-order pharmacy and the first certified pharmacy to dispense GenBioPro generic mifepristone. Fills prescriptions in multiple states and aims to dispense within 24 hours of receiving prescription.
• Danco LaboratoriescoreStrategic or Co-development PartnerCo-manufacturer of mifepristone (brand name Mifeprex) and co-defendant in multiple lawsuits defending FDA mifepristone regulations. Both companies intervened together in Louisiana v. FDA and other cases to protect medication abortion access.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Organon & Co. Organon is a global women's health pharmaceutical company with established products across contraception, fertility, and menopause. While not in medical abortion, it competes for the same prescriber and patient mindshare and represents an incumbent women's-health player that could expand into adjacent indications.
• Perrigo Company: Perrigo is a large generic pharmaceutical manufacturer with women's health and reproductive product lines. It represents a potential generic competitor or partner for mifepristone and a comparable business model for US generic distribution.
• Bayer (Women's Health): Bayer's pharmaceutical division includes a major women's health franchise (e.g., Mirena, Yaz, Ella). It is a broad incumbent in reproductive health and a potential adjacent entrant, though currently focused on contraception rather than medical abortion.

Emerging players

• Hey Jane: Hey Jane is a telehealth clinic providing medication abortion (using mifepristone/misoprostol) via mail in states where permitted. It is an emerging downstream channel/customer of GenBioPro, shaping how patients access the regimen and increasingly partnering with pharmacies to fulfill prescriptions.
• Aid Access: Aid Access is an international telemedicine service providing medication abortion, including shipping mifepristone/misoprostol into the US. It intersects with GenBioPro as an alternative sourcing channel for patients in restricted states and represents a partial substitute or complement depending on regulatory outcomes.
• Choix Clinic: Choix is a telehealth medication abortion provider operating in multiple US states, prescribing mifepristone/misoprostol through certified pharmacies. It is a prescriber-side customer of GenBioPro's regimen and an emerging competitor for direct-to-patient abortion care delivery.
• Honeybee Health: Honeybee Health is an online pharmacy that was the first certified pharmacy to dispense GenBioPro's generic mifepristone. It is both a key channel partner and a representative example of the mail-order pharmacy model that competes for telehealth-enabled abortion care delivery.

Regional players

• Linepharma International: Linepharma is an international manufacturer of mifepristone (marketed as Medabon in combination packs) primarily outside the US. It is a regional peer offering the same molecule in other geographies and represents a potential alternative source if US supply is disrupted.

Direct peers

• Danco Laboratories: Danco Laboratories manufactures brand-name Mifeprex (mifepristone 200mg), the originator product GenBioPro's generic is AB-rated to. Danco is a direct peer in the same molecule, indication, REMS-restricted channel, and is also GenBioPro's frequent co-defendant in litigation defending mifepristone access.

Others

• McKesson Corporation: McKesson is one of the largest US pharmaceutical wholesalers and authorized distributors handling GenBioPro's generic mifepristone to certified prescribers and pharmacies. It is an infrastructure/ecosystem participant rather than a direct competitor but is materially relevant to distribution scale and reliability.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/genbiopro-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about GenBioPro