ALORA Drug Patent Profile

Which patents cover Alora, and when can generic versions of Alora launch?

Alora is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ALORA is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alora

A generic version of ALORA was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for ALORA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,373
Drug Prices:	Drug price information for ALORA
What excipients (inactive ingredients) are in ALORA?	ALORA excipients list
DailyMed Link:	ALORA at DailyMed

See drug prices for ALORA

US Patents and Regulatory Information for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996		DISCN	No	No

Expired US Patents for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996

International Patents for ALORA

See the table below for patents covering ALORA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69133123
Austria	225166
Portugal	99749	PROCESSO DE PREPARACAO DE UMA COMPOSICAO INCREMENTADORA DA PERMEACAO NA PELE
Canada	2098196	METHODE ET SYSTEMES POUR L'ADMINISTRATION DE MEDICAMENTS PARVOIE PERCUTANEE, A L'AIDE D'ESTERS DE SORBITANNE PERMETTANT UNE MEILLEURE ABSORPTION AU NIVEAU DE LA PEAU (METHOD AND SYSTEMS FOR ADMINISTERING DRUGS TRANSDERMALLY USING SORBITAN ESTERS AS SKIN PERMEATION ENHANCERS)
Denmark	0561983
Canada	2098195	DISPOSITIF D'ADMINISTRATION, PAR VOIE PERCUTANEE, DE MEDICAMENTS DONT LA CONCENTRATION EST SOUS-SATUREE; CE DISPOSITIF PERMET UN MEILLEUR ECOULEMENT DU MEDICAMENT (SUBSATURATED TRANSDERMAL DRUG DELIVERY DEVICE EXHIBITING ENHANCED DRUG FLUX)
Australia	9175791

Supplementary Protection Certificates for ALORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

ALORA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Alora Pharmaceuticals

Introduction to Alora Pharmaceuticals

Alora Pharmaceuticals is an emerging leader in the specialty pharmaceuticals and pharmaceutical manufacturing markets. The company has been actively expanding its portfolio through strategic acquisitions and partnerships, positioning itself for significant growth in the industry.

Recent Acquisitions and Partnerships

Acquisition of Osmotica's Legacy Business

In 2021, Alora Pharmaceuticals acquired the legacy business of Osmotica Pharmaceuticals, including manufacturing operations in Marietta, Georgia, and a range of legacy products. This acquisition was part of a strategic process that saw Osmotica receive a $110 million upfront cash payment, with the potential for up to $60 million in additional milestone payments[2][5].

This move bolstered Alora's platform of generic and branded product lines and enhanced its contract research and development, as well as manufacturing capabilities. The acquisition aligns with Alora's strategy to build a diverse portfolio of high-quality branded and generic products.

Divestment of DSUVIA from AcelRx Pharmaceuticals

In March 2023, Alora Pharmaceuticals acquired DSUVIA, an FDA-approved drug for acute pain management, from AcelRx Pharmaceuticals. The agreement included a 15% royalty on commercial sales and a 75% royalty on Department of Defense (DoD) sales, along with potential sales-based milestone payments of up to $116.5 million[3][4].

This acquisition expands Alora's pain management portfolio and leverages its expertise in commercializing products in hospital settings. The deal also allowed AcelRx to focus on its late-stage development assets, such as the nafamostat program, Niyad™.

Market Growth and Trends

Iron Drugs Market

Alora Pharmaceuticals is also a player in the iron drugs market, which is expected to grow significantly. The global iron drugs market is projected to increase by USD 4.58 billion from 2024 to 2028, with a CAGR of 10.87%. This growth is driven by the increasing prevalence of iron deficiency globally and the expansion of chronic kidney disease (CKD) dialysis centers in emerging economies[1].

Pain Management Market

The acquisition of DSUVIA positions Alora strongly in the pain management market, particularly in medically supervised settings such as hospitals, surgical centers, and emergency departments. This market segment is crucial as it addresses the need for effective opioid analgesics in acute pain management.

Financial Implications

Revenue and Royalties

The acquisition of DSUVIA from AcelRx Pharmaceuticals includes significant revenue streams through royalties. Alora will receive 15% royalties on commercial sales and 75% royalties on DoD sales, along with potential milestone payments. This structure ensures a steady and potentially lucrative revenue stream for Alora[3][4].

Milestone Payments and Upfront Cash

The deal with Osmotica Pharmaceuticals involved a substantial upfront cash payment of $110 million, with the potential for up to $60 million in additional milestone payments. This influx of capital has helped Alora retire a portion of its outstanding indebtedness and invest in the growth of its business[2][5].

Cost Savings and Efficiency

The integration of Osmotica's legacy business and the acquisition of DSUVIA have allowed Alora to streamline its operations and enhance its manufacturing and commercialization capabilities. This efficiency is expected to reduce costs and improve the overall financial health of the company.

Competitive Landscape

Key Market Players

Alora Pharmaceuticals operates in a competitive landscape that includes major players such as Abbott Laboratories, AbbVie Inc., GlaxoSmithKline Plc, Sanofi SA, and others. However, Alora's diverse portfolio and its focus on high-quality branded and generic products position it as a significant competitor in the market[1].

Strategic Advantage

Alora's strategic acquisitions and partnerships have provided it with a unique advantage. The company's ability to commercialize products effectively in hospital settings, combined with its robust manufacturing capabilities, makes it an attractive partner for other pharmaceutical companies looking to expand their market reach.

Future Outlook

Expansion of Product Lines

Alora is expected to continue expanding its product lines through both organic growth and strategic acquisitions. The company's focus on pain management and other therapeutic areas positions it for significant growth in the coming years.

Investment in R&D

The acquisition of Osmotica's legacy business and the integration of DSUVIA have enhanced Alora's contract research and development capabilities. This investment in R&D is crucial for developing new products and maintaining a competitive edge in the market.

Key Takeaways

• Strategic Acquisitions: Alora Pharmaceuticals has strengthened its position through the acquisition of Osmotica's legacy business and the divestment of DSUVIA from AcelRx Pharmaceuticals.
• Market Growth: The company is poised to benefit from growing markets such as the iron drugs market and the pain management market.
• Financial Health: The deals have provided significant upfront cash payments and potential milestone payments, improving Alora's financial health.
• Competitive Advantage: Alora's diverse portfolio and expertise in commercializing products in hospital settings give it a competitive edge.
• Future Expansion: The company is expected to continue expanding its product lines and investing in R&D to drive future growth.

FAQs

What was the significance of Alora Pharmaceuticals acquiring Osmotica's legacy business?

The acquisition of Osmotica's legacy business provided Alora with manufacturing operations in Marietta, Georgia, and a range of legacy products, bolstering its platform of generic and branded product lines and enhancing its contract research and development and manufacturing capabilities[2][5].

How does the acquisition of DSUVIA benefit Alora Pharmaceuticals?

The acquisition of DSUVIA expands Alora's pain management portfolio and leverages its expertise in commercializing products in hospital settings. It also includes significant revenue streams through royalties and potential milestone payments[3][4].

What is the projected growth of the iron drugs market, and how does it impact Alora Pharmaceuticals?

The global iron drugs market is projected to grow by USD 4.58 billion from 2024 to 2028, with a CAGR of 10.87%. This growth, driven by the increasing prevalence of iron deficiency globally, positions Alora as a key player in this market[1].

How has Alora Pharmaceuticals' financial health been impacted by recent acquisitions?

The acquisitions have provided Alora with substantial upfront cash payments and potential milestone payments, improving its financial health and allowing it to retire a portion of its outstanding indebtedness[2][5].

What are Alora Pharmaceuticals' plans for future growth?

Alora plans to continue expanding its product lines through both organic growth and strategic acquisitions, and it will invest in R&D to develop new products and maintain a competitive edge in the market.

Sources

1. CB Insights: Iron Drugs Market size is set to grow by USD 4.58 billion from 2024-2028[1].
2. Osmotica Pharmaceuticals: Osmotica Pharmaceuticals plc Announces Conclusion of Strategic Process with Agreement for the Sale of Legacy Business to Alora Pharmaceuticals LLC[2].
3. PR Newswire: AcelRx Pharmaceuticals Announces Divestment of DSUVIA® to Alora Pharmaceuticals[3].
4. PR Newswire: AcelRx Pharmaceuticals Announces Closing of Divestment of DSUVIA® to Alora Pharmaceuticals[4].
5. GlobeNewswire: Osmotica Pharmaceuticals plc Announces Conclusion of Strategic Process with Agreement for the Sale of Legacy Business to Alora Pharmaceuticals LLC[5].