Hikma acquires Novugen's FDA-approved ANDA for trametinib
Hikma Pharmaceuticals has acquired the FDA-approved ANDA for trametinib tablets from Novugen, securing 180 days of US generic market sales exclusivity. The agreement positions Hikma to handle US sales and marketing while Novugen manages manufacturing and supply.
Trametinib, an oral kinase inhibitor for cancer treatment, generated approximately $436 million in US sales under the brand name Mekinist® in the 12 months ending December 2024. This strategic acquisition strengthens Hikma's generics portfolio in oncology and expands its pipeline of essential medicines.
The partnership aims to increase access to cost-efficient cancer treatments in the US market, where Hikma maintains a strong presence in complex generic technologies, including being the largest supplier by volume of nasal sprays.
Hikma Pharmaceuticals ha acquisito l’ANDA approvata dalla FDA per le compresse di trametinib da Novugen, ottenendo 180 giorni di esclusiva per la vendita di generici negli Stati Uniti. L’accordo prevede che Hikma gestisca le vendite e il marketing negli USA, mentre Novugen si occupa della produzione e della fornitura.
Il trametinib, un inibitore orale delle chinasi utilizzato nel trattamento del cancro, ha generato circa 436 milioni di dollari di vendite negli Stati Uniti con il nome commerciale Mekinist® nei 12 mesi fino a dicembre 2024. Questa acquisizione strategica rafforza il portafoglio di farmaci generici oncologici di Hikma e amplia la sua pipeline di medicinali essenziali.
La partnership mira a migliorare l’accesso a trattamenti oncologici più economici nel mercato statunitense, dove Hikma detiene una posizione di rilievo nelle tecnologie generiche complesse, essendo anche il maggior fornitore per volume di spray nasali.
Hikma Pharmaceuticals ha adquirido el ANDA aprobado por la FDA para tabletas de trametinib de Novugen, asegurando 180 días de exclusividad en la venta de genéricos en EE. UU. El acuerdo posiciona a Hikma para manejar las ventas y el marketing en EE. UU., mientras que Novugen se encarga de la fabricación y el suministro.
El trametinib, un inhibidor oral de quinasa para el tratamiento del cáncer, generó aproximadamente 436 millones de dólares en ventas en EE. UU. bajo la marca Mekinist® en los 12 meses que finalizaron en diciembre de 2024. Esta adquisición estratégica fortalece el portafolio de genéricos oncológicos de Hikma y amplía su pipeline de medicamentos esenciales.
La asociación busca aumentar el acceso a tratamientos contra el cáncer más económicos en el mercado estadounidense, donde Hikma mantiene una fuerte presencia en tecnologías genéricas complejas, siendo además el mayor proveedor por volumen de aerosoles nasales.
히크마 파마슈티컬스(Hikma Pharmaceuticals)는 노뷰젠(Novugen)으로부터 FDA 승인된 트라메티닙 정제에 대한 ANDA를 인수하여 미국에서 180일간의 제네릭 판매 독점권을 확보했습니다. 이번 계약으로 히크마는 미국 내 판매 및 마케팅을 담당하고, 노뷰젠은 제조 및 공급을 맡게 됩니다.
트라메티닙은 암 치료를 위한 경구용 키나제 억제제로, 2024년 12월까지 12개월 동안 브랜드명 메키니스트®로 미국에서 약 4억 3,600만 달러의 매출을 기록했습니다. 이번 전략적 인수는 히크마의 종양학 분야 제네릭 포트폴리오를 강화하고 필수 의약품 파이프라인을 확장합니다.
이 파트너십은 미국 시장에서 비용 효율적인 암 치료제 접근성을 높이는 것을 목표로 하며, 히크마는 복잡한 제네릭 기술 분야에서 강력한 입지를 유지하고 있으며, 비강 스프레이 부문에서는 최대 공급업체입니다.
Hikma Pharmaceuticals a acquis l’ANDA approuvée par la FDA pour les comprimés de trametinib auprès de Novugen, obtenant ainsi 180 jours d’exclusivité de vente de génériques aux États-Unis. Cet accord place Hikma en charge des ventes et du marketing aux États-Unis, tandis que Novugen gère la fabrication et l’approvisionnement.
Le trametinib, un inhibiteur oral de kinase utilisé dans le traitement du cancer, a généré environ 436 millions de dollars de ventes aux États-Unis sous la marque Mekinist® au cours des 12 mois se terminant en décembre 2024. Cette acquisition stratégique renforce le portefeuille de génériques oncologiques de Hikma et élargit son pipeline de médicaments essentiels.
Le partenariat vise à améliorer l’accès à des traitements contre le cancer plus abordables sur le marché américain, où Hikma détient une position forte dans les technologies génériques complexes, étant également le principal fournisseur en volume de sprays nasaux.
Hikma Pharmaceuticals hat die von der FDA zugelassene ANDA für Trametinib-Tabletten von Novugen erworben und sich damit 180 Tage Exklusivität für den Verkauf von Generika in den USA gesichert. Die Vereinbarung sieht vor, dass Hikma den Vertrieb und das Marketing in den USA übernimmt, während Novugen die Herstellung und Lieferung verantwortet.
Trametinib, ein oraler Kinase-Inhibitor zur Krebsbehandlung, erzielte in den 12 Monaten bis Dezember 2024 unter dem Markennamen Mekinist® einen Umsatz von rund 436 Millionen US-Dollar in den USA. Diese strategische Übernahme stärkt Hikmas Generika-Portfolio im Onkologie-Bereich und erweitert die Pipeline wichtiger Arzneimittel.
Die Partnerschaft zielt darauf ab, den Zugang zu kostengünstigen Krebstherapien auf dem US-Markt zu verbessern, wo Hikma eine starke Position im Bereich komplexer Generika-Technologien innehat und zudem der größte Anbieter von Nasensprays nach Volumen ist.
- Secured 180-day exclusivity period for generic trametinib in US market
- Target product has significant market value ($436M in annual sales)
- Expands presence in high-value oncology market
- No upfront manufacturing investment required (Novugen handles production)
- Additional marketing and sales expenses required
- Dependency on Novugen for manufacturing and supply
- Competition from brand name product (Mekinist®) may affect market share
Insights
Hikma's acquisition of trametinib ANDA offers 180 days of exclusivity for a $436M product, significantly boosting revenue potential in high-value oncology market.
Hikma's acquisition of the FDA-approved trametinib ANDA from Novugen represents a strategically significant move with substantial revenue implications. The deal grants Hikma exclusive first-to-file status with 180 days of US market exclusivity - the most valuable period in any generic product lifecycle. With the branded version (Mekinist) generating
The partnership structure is particularly efficient: Hikma leverages its established commercial infrastructure while Novugen handles manufacturing. This allows each company to focus on core competencies without Hikma needing to invest in additional manufacturing capabilities for this complex oncology product.
Trametinib, an orally administered kinase inhibitor, strengthens Hikma's position in the high-value oncology market. Generic oncology medications typically maintain higher margins than conventional generics while improving treatment affordability. This aligns perfectly with Hikma's stated strategy of expanding in growing therapeutic areas with high patient need.
First-to-market generic entrants typically capture substantial market share during exclusivity periods, often with less price erosion than seen with multiple competitors. While the article doesn't specify the launch timeline, this acquisition positions Hikma to capitalize on a significant market opportunity while diversifying its product portfolio in the complex generics space where they already have established expertise.
Trametinib acquisition strengthens Hikma's oncology portfolio with 180-day exclusivity for a targeted therapy with $436M annual sales and strategic market positioning.
Hikma's acquisition of the trametinib ANDA represents a valuable addition to the oncology generics landscape. Trametinib is a MEK inhibitor primarily used in treating BRAF-mutated melanoma and certain other cancers, often as part of combination therapy regimens. As a targeted therapy, it commands higher reimbursement and stronger patient adherence compared to conventional chemotherapies.
The 180-day exclusivity period is particularly valuable in the oncology space where prescribers tend to be more reluctant to switch patients between manufacturers once treatment has begun. This creates a sustained advantage beyond the exclusivity window as patients often remain on the initial generic version.
With reference brand Mekinist generating
For patients, this generic entry will improve affordability for a critical cancer therapy. For Hikma, it establishes stronger relationships with oncology prescribers and payers, potentially creating pathways for future oncology product launches. The partnership with Novugen balances risk appropriately, allowing specialized manufacturing while leveraging Hikma's established commercial infrastructure in the US market.
Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.
"Hikma's Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans."
"As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen's innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma's strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."
According to IQVIA, US sales of trametinib, sold under the brand name Mekinist® (trametinib) Tablets, were approximately
Hikma's Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US1.
1IQVIA MAT December 2024, volumes by eaches
Mekinist® is a registered trademark of Novartis Pharma AG
This product has been approved for marketing in
Enquiries
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Susan Ringdal EVP, Strategic Planning and Global Affairs | +44 (0)20 7399 2760/ +44 7776 477050 |
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About Hikma
(LSE: HIK) (NASDAQ
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the
About Novugen
Novugen is a wholly owned subsidiary of SciTech International, a
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SOURCE Hikma Pharmaceuticals USA Inc.
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