Cosette Pharmaceuticals

What Cosette Pharmaceuticals does

Cosette Pharmaceuticals is a US-based, privately held specialty pharmaceutical company headquartered in Bridgewater, New Jersey, that develops, manufactures, and commercializes both branded specialty pharmaceutical products and generic prescription drugs. Formed in December 2018 when Avista Capital Partners acquired the extended topicals and dermatology portfolio of G&W Laboratories, the company has since expanded through a series of targeted acquisitions into women's health (Vyleesi, Intrarosa, CLOMID), cardiology (Benicar family, Welchol, Azor, Tribenzor, Effient), dermatology and topicals (Abreva NBE, tazarotene, clindamycin generics), neurology rare disease (SYMPAZAN for Lennox-Gastaut Syndrome), pain/inflammation (Indocin, Sprix, Zipsor, Cambia), and CNS (Ambien/Ambien CR). The company markets approximately 21 branded specialty pharmaceutical products and more than 100 generic products, supported by a direct commercial sales force, traditional US retail/wholesale distribution, an online pharmacy partnership with Mark Cuban Cost Plus Drug Company, and a global distributor network for Intrarosa.

Cosette operates two state-of-the-art US manufacturing facilities in New Jersey and Lincolnton, North Carolina, with capabilities in complex dosage forms including topical creams, ointments, oral liquids and solutions, suppositories, and injectables. The company runs an internal R&D and regulatory operation that has secured four Competitive Generic Therapy (CGT) approvals with 180-day market exclusivity (TAZORAC, RECTIV, CIPRO HC, plus metronidazole), and holds long-dated patent estates on branded assets (Welchol to 2037, Intrarosa to 2033, Vyleesi to 2041, SYMPAZAN to 2040). A separate CDMO division monetizes excess manufacturing and technical capacity for external clients.

The company is jointly controlled by Avista Capital Partners and Hamilton Lane (Nasdaq: HLNE) following Hamilton Lane's July 2024 acquisition of a significant equity interest. Revenue is generated through one-time product sales across branded and generic SKUs in the US (and selected international markets for Intrarosa), with CDMO contributing professional services revenue. The company does not publicly disclose its financial results, but disclosed product-level US annual sales across acquired and core assets (Daiichi portfolio $123M, Assertio portfolio $48.9M, Ambien $39M, metronidazole vaginal gel $45M, CIPRO HC $17.9M, RECTIV $21.2M) indicate a multi-product revenue base spread across therapeutic areas, channels, and customer types (retail pharmacy, online pharmacy, wholesale, international distributors).

Name

Cosette Pharmaceuticals

Legal name

Cosette Pharmaceuticals, Inc.

Website

https://cosettepharma.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

251–500 employees

Short description

Cosette Pharmaceuticals is a US-based specialty pharmaceutical company that develops, manufactures, and commercializes branded and generic prescription drugs across women's health, cardiology, dermatology, neurology, and pain management, serving patients, healthcare providers, and pharmacy distribution partners through US manufacturing and a direct commercial sales force.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Dermatology Specialty Pharmaceuticals (HLAIACAL)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

Keywords

• Specialty pharmaceutical products
• Generic pharmaceutical manufacturing
• Branded women's health drugs
• Contract manufacturing services
• Cardiovascular and neurology drugs

Headquarters

HQ city

Bridgewater

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Branded Specialty Pharmaceuticals: Cosette generates revenue through sale of branded specialty pharmaceutical products including women's health (Vyleesi, Intrarosa, CLOMID), cardiology (Benicar, Welchol, Azor, Tribenzor, Effient), neurology (SYMPAZAN), dermatology, and inflammation/pain products (INDOCIN, SPRIX, ZIPSOR, CAMBIA).
2. Generic Pharmaceuticals: Revenue from generic pharmaceutical products including first-to-market generics under CGT exclusivity pathway, such as CIPRO HC, TAZORAC, RECTIV, Metronidazole Gel, and others. Cosette has launched 24+ new products over three years.
3. CDMO/Contract Manufacturing: Cosette operates a Contract Development and Manufacturing Organization (CDMO) division offering manufacturing and technical services to external clients, leveraging their state-of-the-art facilities in Lincolnton, NC and New Jersey.
4. OTC/Consumer Products: Cosette markets over-the-counter products including National Brand Equivalent versions of Abreva and operates partnerships for OTC distribution.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Cosette Pharmaceuticals is a US-based, fully integrated specialty pharmaceutical company that develops, manufactures, and markets branded specialty pharmaceutical products and generic equivalents across women's health, cardiology, neurology rare diseases, dermatology, and pain/inflammation therapeutic areas. The company operates manufacturing facilities in New Jersey and North Carolina, leverages internal R&D for first-to-market generic launches with Competitive Generic Therapy (CGT) exclusivity, and acquires established brands from major pharmaceutical companies. Cosette also operates a Contract Development and Manufacturing Organization (CDMO) division offering manufacturing and technical services to external clients.

Product overview

Cosette Pharmaceuticals is a US-based, fully integrated specialty pharmaceutical company with a diverse portfolio of branded and generic products. The company markets approximately 21 branded specialty pharmaceutical products and more than 100 generic products across therapeutic areas including women's health (Vyleesi®, Intrarosa®, CLOMID®), cardiovascular (BENICAR®, WELCHOL®, AMBIEN®), and dermatology/generics. The company operates manufacturing facilities in New Jersey and North Carolina, focusing on complex dosage forms including topical creams, ointments, oral liquids/solutions, suppositories, and injectables. Recent strategic acquisitions have expanded the portfolio into neurology rare diseases (SYMPAZAN® for Lennox-Gastaut Syndrome) and pain/inflammation management (INDOCIN®, SPRIX®, ZIPSOR®, CAMBIA®). The company leverages internal R&D capabilities for generic drug development, achieving multiple first-to-market approvals including Competitive Generic Therapy (CGT) exclusivities, while also acquiring established brands from major pharmaceutical companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Vyleesi (Bremelanotide Injection) FDA-approved as-needed treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. The only FDA-approved product for this indication with 8 consecutive quarters of double-digit prescription growth.
• Intrarosa Prescription product providing both estrogen and androgen for treatment of moderate-to-severe dyspareunia (symptom of vulvar and vaginal atrophy due to menopause). Unique label without boxed safety warning. 108 patents with protection until 2033.
• CLOMID (clomiphene citrate) Proven fertility medication that stimulates hormones to support ovulation. One of the most widely dispensed prescription fertility medications in the US with 30% pregnancy success rate. Available via Cost Plus Drugs partnership.
• Ambien and Ambien CR (Zolpidem Tartrate) Sleep aid medications acquired from Sanofi US for the US market. Ambien CR is the extended-release formulation. Combined US annual sales of approximately $39 million.
• BENICAR (olmesartan medoxomil) Angiotensin II receptor blocker for hypertension treatment. Acquired from Daiichi Sankyo as part of eight-product cardiovascular portfolio.
• BENICAR HCT (olmesartan medoxomil/hydrochlorothiazide) Combination antihypertensive medication with diuretic. Part of Daiichi Sankyo cardiovascular portfolio acquisition.
• WELCHOL (colesevelam HCL) Bile acid sequestrant for cholesterol management available in tablet and oral suspension forms. Cosette holds US Patent 11,291,628 for Welchol Chewable Bar (novel drug delivery system) with protection until 2037.
• AZOR (amlodipine/olmesartan medoxomil) Combination calcium channel blocker and angiotensin II receptor blocker for hypertension.
• TRIBENZOR (olmesartan medoxomil/amlodipine/hydrochlorothiazide) Triple-combination antihypertensive medication.
• EFFIENT (prasugrel) Antiplatelet agent for reduction of thrombotic cardiovascular events.
• EVOXAC (cevimeline HCL) Cholinergic agonist for treatment of dry mouth.
• SYMPAZAN (clobazam) oral film FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome. First and only FDA-approved oral film formulation. Patent protection until 2040. Establishes Cosette's neurology rare disease footprint.
• INDOCIN (indomethacin) NSAID available in oral suspension and suppository forms for inflammation and pain management.
• SPRIX (ketorolac tromethamine) nasal spray NSAID nasal spray for acute pain management.
• ZIPSOR (diclofenac potassium) liquid-filled capsules NSAID in liquid-filled capsule formulation for pain and inflammation.
• CAMBIA (diclofenac potassium) for oral solution NSAID oral solution for migraine treatment.
• CIPRO HC Generic (ciprofloxacin/hydrocortisone otic suspension) First generic version of CIPRO HC for acute otitis externa. First approved generic in more than 27 years. 180 days CGT exclusivity.
• RECTIV Generic (nitroglycerin ointment 0.4%) First generic version of RECTIV (nitroglycerin) ointment, 0.4% for anal fissures. 180 days CGT exclusivity.
• TAZORAC Generic (tazarotene gel) First generic versions of TAZORAC tazarotene gel in 0.05% and 0.1% concentrations. 180 days CGT exclusivity.
• Metronidazole Vaginal Gel 0.75% Generic version of MetroGel-Vaginal for bacterial vaginosis. Women's health product.
• Metronidazole Gel USP, 1% Generic dermatological gel for rosacea treatment.
• Prochlorperazine Edisylate Injection First injectable product for Cosette. Generic equivalent for Compazine Injection. Used for severe nausea, vomiting, and schizophrenia.
• Griseofulvin Oral Suspension 125 mg/5 mL Antifungal medication for fungal infections. Addressed supply chain constraints in market.
• Betaine Anhydrous for Oral Solution AB-rated to Cystadane for treatment of homocystinuria (rare genetic condition). Obtained from ANI Pharmaceuticals.
• Abreva Generic (Docosanol Cream 10%) National Brand Equivalent of Abreva for cold sores. Available in 2gm tube and pump formats (first pump format approval).
• Clindagel Generic (clindamycin phosphate EQ 1%) First generic version of Clindagel topical gel for acne. Manufactured by Cosette for Solaris Pharma. Day-1 launch.
• Hydrocortisone Valerate Cream USP, 0.2% First cycle FDA approval for topical corticosteroid. First ANDA approval of 2021 from internal R&D pipeline.
• Cosette CDMO Contract Manufacturing Services Contract Development and Manufacturing Organization (CDMO) offering manufacturing and technical services to external pharmaceutical clients, leveraging state-of-the-art facilities in Lincolnton, NC and New Jersey with expertise in complex dosage forms including topical creams, ointments, oral liquids/solutions, suppositories, and injectables.

Quantifiable outcome

• 24 new product launches over three years with zero major quality observations
• +2 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Eight partnerships are on record, tiered core and minor.

• Mark Cuban Cost Plus Drug CompanycoreGTM or Marketing Partner · 3 October 2023Cosette partnered with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) to offer CLOMID (clomiPHENE citrate) 50mg tablets at low cash prices via the Cost Plus Drugs online pharmacy. This partnership improves patient access and affordability for fertility medication by eliminating middlemen and passing savings directly to consumers.
• Alembic Pharmaceuticals / Aleor DermaceuticalscoreStrategic or Co-development Partner · 24 May 2022Cosette collaborated with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals, for the FDA approval and launch of a National Brand Equivalent version of Abreva (Docosanol Cream 10%) in tube and pump formats. This partnership leveraged Cosette's manufacturing capabilities and commercial expertise.
• MSH Pharma Inc.coreStrategic or Co-development PartnerPartnership with MSH Pharma Inc. for commercialization of Intrarosa, leveraging unique commercial and manufacturing capabilities to ensure patient access.
• Global Intrarosa Distribution Partners (Theramex, Tecnimede, Avia, Lupin, Dexcel, Labatec, Lacer, Lee's Pharma, Valenta)coreChannel Partner/ Reseller/ DistributorInternational distribution network for Intrarosa covering US, UK, EU, Canada, Israel markets through partners including Theramex, Tecnimede, Avia, Lupin, Dexcel, Labatec, Lacer, Lee's Pharma, and Valenta, with Asian market launches planned for 2025.
• Women's Resource Center (WRC)minorStrategic or Co-development PartnerCosette supports WRC to promote women's self-sufficiency by providing individualized services and connections to local resources in North Carolina communities.
• Birth HavenminorStrategic or Co-development PartnerCosette supports Birth Haven, an organization offering shelter and hope for young mothers and their children, demonstrating commitment to women's health community support beyond medication provision.
• Resolve (National Infertility Association)minorStrategic or Co-development PartnerCosette partners with Resolve, the national infertility association, as an advocate sponsor of National Infertility Awareness Campaign to increase patient awareness through education and community building.
• ANI Pharmaceuticals, Inc.minorChannel Partner/ Reseller/ DistributorCosette obtained US marketing rights to Betaine Anhydrous for Oral Solution in an agreement with ANI Pharmaceuticals, expanding access to treatments for patients with homocystinuria.

Scale indicators10 records

Recent moves8 records

Expansion highlights3 records

Regional players

• Theramex: Theramex is a UK/Europe-focused women's health specialty pharma and an Intrarosa distribution partner for Cosette in international markets. Comparable as a women's health specialty player but with a regional rather than US-centric footprint.

Emerging players

• Lupin Pharmaceuticals: Lupin is an India-based global generic manufacturer with significant US operations. Cosette's CFO Rick Casten previously served as VP Finance at Lupin, and Lupin is also a global Intrarosa distribution partner, making it an overlapping peer across both generic competition and partnerships.

Broad incumbents

• Bausch Health: Bausch Health is a broad specialty pharma incumbent with dermatology (Ortho Dermatologics), women's health, and generics businesses. It overlaps with Cosette's therapeutic focus areas at a much larger scale and serves as a competitive reference point.
• Endo Pharmaceuticals: Endo is a large US specialty pharma with branded and generic injectable, urology, and pain products. Comparable as a broad incumbent in the same therapeutic adjacencies (women's health, pain, neurology), though considerably larger and more diversified than Cosette.

Others

• Alembic Pharmaceuticals: Alembic is an India-based API and generics manufacturer whose subsidiary Aleor Dermaceuticals co-developed the Abreva generic with Cosette. Functions as both a partner and adjacent peer in the complex generics and dermatology space.

Direct peers

• Amneal Pharmaceuticals: Amneal is a US-based specialty and generic pharmaceutical company with a comparable mix of branded specialty, complex generics, and CDMO services. Cosette's CEO Apurva Saraf and SVP of Operations Vincent Colicchio both previously held senior roles at Amneal, signaling direct cultural and operational overlap.
• Upsher-Smith Laboratories: Upsher-Smith is a US-based, privately held specialty generics manufacturer with deep dermatology and women's health portfolios. Brad Leonard, Cosette's VP of Commercial Operations, spent his career at Upsher-Smith, indicating strong operational and portfolio overlap.
• Padagis: Padagis (formerly Perrigo's generics prescription business) is a US-focused specialty generics company with strong topical and dermatology capabilities, comparable to Cosette's G&W Labs origin story and complex generics pipeline.
• ANI Pharmaceuticals: ANI is a US specialty/generic pharma that acquires and commercializes established branded and generic products, including women's health assets like Betaine Anhydrous (which Cosette licensed from ANI). Highly comparable business model of acquiring niche/specialty products and maximizing portfolio value.
• Slayback Pharmaceuticals: Slayback is a US specialty pharma that developed and commercialized complex generics and specialty products, recently sold to Azurity. Ted Smolenski (Cosette VP of Business Development) previously led BD at Slayback, and the company mirrors Cosette's specialty-generic hybrid model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cosette-pharmaceuticals-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries4 records

Funding overview

Funding rounds2 records

Investors2 records

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

M&A3 records

Investments

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

Frequently asked questions about Cosette Pharmaceuticals